Developing Initial Programme Theories for a Realist Evaluation of an Intervention to Support Adults in Adapting to Life With Type 1 Diabetes: Methodological Insights and Implications for Practice

Abstract

A key component of realist evaluation is the development of initial programme theories. However, methods for developing initial programme theories are often underreported and there is limited guidance on how to construct initial programme theories based on exploratory qualitative data. In this article, we attend to these gaps by describing the development of initial programme theories for a realist evaluation of an intervention to support adults in adapting to life with type 1 diabetes. Our development of initial programme theories was based on literature related to the intervention, creative writing sessions, qualitative data from a feasibility study of the intervention, and input from stakeholders. The stakeholders included healthcare professionals delivering the intervention, an advisory group of the realist evaluation study involving people with diabetes and healthcare professionals, and a realist research peer support group. We applied a retroductive analysis approach to identify causal insights related to the intervention and develop initial programme theories. The initial programme theories were shared with the stakeholders which led to further refinement of the theories. We grouped the final initial programme theories into ten categories which illustrate the connections between contexts, mechanisms, and outcomes of the intervention. Based on our process of developing initial programme theories, we suggest using qualitative data to construct and refine programme theories although the data may not have been collected with a realist evaluation perspective. Furthermore, we encourage using visual aids to engage stakeholders in programme theory building and suggest that researchers adapt their approach to engage stakeholders according to the different stakeholder groups involved.

Keywords

realist evaluation initial programme theory exploratory data psychosocial support type 1 diabetes newly diagnosed

Introduction

Even though more than half of people living with type 1 diabetes are diagnosed in adulthood (Harding et al., 2022; Leslie et al., 2021), adults with new-onset type 1 diabetes have received limited attention in the literature (Due-Christensen et al., 2023). Psychosocial support interventions can have a significant impact on how adults with new-onset type 1 diabetes cope with and manage their condition (Due-Christensen et al., 2023). Accordingly, there is a need to address how supportive interventions among adults with new-onset diabetes work and the factors that promote or inhibit these outcomes (Due-Christensen et al., 2023).

Theory-driven approaches to evaluation such as realist evaluation have gained increasing attention in the literature (Malengreaux et al., 2022). Rather than assuming a linear model of causality, realist evaluation seeks to provide an understanding of how, when and for whom an intervention works (Fick & Muhajarine, 2019; Smeets et al., 2022). Realist evaluation is based on realist philosophy which suggests that reality is stratified in layers and that underpinning generative forces are the cause of things happening (Jagosh, 2019). The first step of conducting a realist evaluation is to formulate initial programme theories (Flynn et al., 2020; Mukumbang et al., 2017). Initial programme theories refer to a set of ideas about what the intervention is intended to achieve and how this will be achieved (Pawson & Tilley, 1997). The next step of the realist evaluation approach is to test the initial programme theories using qualitative and/or quantitative methods (Fick & Muhajarine, 2019). Based on these insights, the initial programme theories are refined to clarify and illustrate how and why the intervention works or does not work (Wong et al., 2016). Conducting a realist evaluation is an iterative rather than a linear process of testing and refining initial programme theories (Fick & Muhajarine, 2019).

While there are several approaches to identify initial programme theories, their real-world application is often underreported and there are few practical examples of how to construct initial programme theories (Fick & Muhajarine, 2019; Griffiths et al., 2022; Malengreaux et al., 2024). For example, there is limited guidance on how to construct initial programme theories based on exploratory qualitative data. This study aims to address these gaps by describing the development of initial programme theories for a realist evaluation using exploratory data from an intervention to support adults in adapting to life with type 1 diabetes.

An Intervention to Support Adults in Adapting to Life With Type 1 Diabetes

A diagnosis of type 1 diabetes in adulthood can be very disruptive as the condition impacts the individual’s everyday life in multiple ways (Due-Christensen et al., 2018, 2019). Research has shown that accommodating the demands of type 1 diabetes into established life routines can lead to significant psychological and social challenges for adults with type 1 diabetes. This includes concerns such as anxiety, feelings of loss or diabetes related distress, which can make managing diabetes more difficult and consequently increase the risk of developing diabetes complications (Due-Christensen et al., 2018; Hessler et al., 2017; Lašaitė et al., 2016). In addition, many adults experience that their psychological and emotional needs are not adequately addressed by healthcare professionals in the period following diagnosis (Due-Christensen et al., 2019). To address these issues, a group of researchers, adults with type 1 diabetes and healthcare professionals co-designed an intervention to support adults in adapting to life with type 1 diabetes (Due-Christensen et al., 2021).

The intervention consists of two parts: A) one-to-one sessions with diabetes specialist healthcare professionals trained in facilitating dialogue about psychosocial aspects of diabetes, and B) group-based psychoeducational sessions addressing psychosocial challenges and strategies for managing diabetes in everyday life facilitated by a peer and a healthcare professional (Due-Christensen et al., 2021). This study focuses on intervention A as this part of the intervention will be implemented in a specialist diabetes clinic which is the organisational context of the realist evaluation. Intervention A includes two visual dialogue tools and a training manual to support healthcare professionals in using the tools. The tools, the Diabetes Roadmap and the Living with Diabetes tool, are intended to address the psychological and social impact of a diagnosis of type 1 diabetes and how to adapt to life with diabetes. Accordingly, they are designed to facilitate dialogue about thoughts and feelings related to the diagnosis, normalise and reframe potential challenges, and encourage solution-focused thinking in the process of adapting to life with diabetes (Due-Christensen et al., 2021). The theoretical framework of the intervention is based on a theory of adapting to diabetes and the bio-psycho-social model (Engel, 1977; Whittemore & Roy, 2002). Furthermore, the intervention is inspired by acceptance and commitment therapy, social learning theory and self-determination theory (Bandura, 2001; Hayes et al., 2006; Ryan & Deci, 2000). The aim of the Diabetes Roadmap is to express how adapting to diabetes in an ongoing process and to lay out what the person with diabetes can expect from their diabetes care during the first year. The tool depicts a winding road starting from the point of diagnosis. Furthermore, it consists of images of different types of healthcare professionals who are part of the treatment course and examples of thoughts and questions people might have in relation to living with type 1 diabetes. The examples of thoughts and questions are intended to support adults in expressing their experience of living with type 1 diabetes and to normalise emotional and social responses they might experience. The aim of the Living with Diabetes tool is to facilitate dialogue about the way diabetes might affect the person’s body, their everyday life and their thoughts and emotions (Due-Christensen et al., 2021). The tool depicts three overlapping petals which represent the body, everyday life, thoughts, and emotions and how these aspects interact. In this way, the tool addresses the complexity of adapting to a diagnosis of type 1 diabetes. The tool also involves some open questions to give adults with type 1 diabetes the opportunity to express and process the biomedical, psychological, and social impacts of diabetes. The tools can be seen in Supplemental material 1.

The intervention was delivered by trained healthcare professionals in one-to-one consultations lasting 30-45 minutes. Each healthcare professional who was tasked with responsibility for delivery of the intervention received six hours of training in therapeutic communication and facilitation skills prior to the intervention and supervision during the implementation. A feasibility study of the intervention has shown that the intervention supported psychosocial adaptation in relation to processing the diabetes diagnosis and navigating a new normality (Due-Christensen et al. 2026). To enhance understanding of how the intervention works, we decided to conduct a realist evaluation of the intervention in a larger study. This study aims to 1) develop initial programme theories for the evaluation by engaging stakeholders and using exploratory qualitative research, 2) describe the methodological steps of developing initial programme theories.

Methods

The study describes the first step of conducting a realist evaluation, namely the construction of initial programme theories for an intervention to support adults with new-onset type 1 diabetes. An initial programme theory articulates the outcomes that an intervention is intended to generate, the mechanisms through which the intervention contributes to particular outcomes as well as the contexts that shape these mechanisms (Mukumbang et al., 2017; Pawson, 2002; Pawson et al., 2005). Mechanisms refer to ways in which people respond to the intervention which can be triggered or constrained by different contexts such as personal and organisational factors (Dalkin et al., 2015; Pawson & Tilley, 1997). Thus, initial programme theories propose how and why the intervention will lead to outcomes and for what kind of settings and populations (Dalkin et al., 2015; Pawson & Tilley, 1997). The process of developing initial programme theories involves articulating and testing hypotheses regarding particular relationships between context, mechanism and outcome. Each of these hypotheses are called a Context-Mechanism-Outcome (CMO) configuration and can help gain a deeper understanding of how the intervention works (Jagosh et al., 2015). Figure 1 shows how we conceptualise context, mechanism and outcome in this study.

Figure 1.

Conceptualisation of context, mechanism and outcome

We relied on several sources to inform the construction of initial programme theories: literature related to the development of the intervention, creative writing sessions, data from a feasibility study of the intervention, as well as input from various stakeholders. These include healthcare professionals delivering the intervention, an advisory group of the realist evaluation study involving people with diabetes and healthcare professionals, and a realist research peer support group. Some of the stakeholders had been involved in developing and feasibility testing the intervention whereas others had no prior knowledge of the intervention. Figure 2 illustrates our process of developing initial programme theories. In accordance with realist inquiry, we adopted an iterative approach to theorising (Jagosh et al., 2022). Thus, the different steps of developing the initial programme theories informed each other.

Figure 2.

Process of developing and refining initial programme theories (IPTs)

Literature Related to the Intervention

The first step of developing initial programme theories was to review literature about the development of the intervention and adults with new-onset type 1 diabetes. One of the key stakeholders (MDC) involved in the process of developing initial programme theories has facilitated the development and feasibility testing of the intervention as part of her PhD and Postdoc studies. Thus, her extensive knowledge about the intervention and adults with new-onset type 1 diabetes guided our choice of studies to include. We included peer reviewed literature about the development of the intervention as well as unpublished literature about the intervention e.g., training manuals for healthcare professionals. When reviewing the literature, we were informed by the following questions (Wong et al., 2013): what assumptions are built into the programme? What assumptions are we (the researchers) making? Which ones do we need to challenge and why? The questions directed our attention towards the specific components of the intervention e.g., dialogue tools, peer support and communication training as well as the implicit or explicit assumptions of these efforts.

Creative Writing Session

As some of the stakeholders had prior knowledge about the intervention, we acknowledged the importance of identifying our assumptions about the intervention and developing theoretical sensitivity to the development of initial programme theories. To do so, we (MDC and RASP) organised a creative writing session to map the components of the intervention and identify potential mechanisms and contexts at play (Wong et al., 2016). In the initial part of the session, we wrote anything that came to mind in relation to the following questions: what is it that the intervention is intended to address?, what are the support needs of adults with new-onset type 1 diabetes?, what do healthcare professionals need to understand about adults with new-onset type 1 diabetes?, and what skills do healthcare professionals need to support adults with new-onset type 1 diabetes? Then, we discussed our ideas and synthesised our notes. We engaged in another round of reflective writing according to the following questions: what is it about the intervention that makes it work?, and what assumptions are we (the researchers) making? Following this, we discussed suggested mechanisms of the intervention and drilled into vague concepts to operationalise our causal claims about the intervention. In doing so, we differentiated between intervention components (mechanism resources) and participants’ reactions (mechanism responses) as this helps distinguish between contexts and mechanisms of the intervention (Dalkin et al., 2015). Supplemental material 2 provides an overview of the mechanisms identified in the creative writing session.

Data From a Feasibility Study of the Intervention

To further develop and refine our initial programme theories we included data from a feasibility study of the intervention (Due-Christensen et al. 2026). The feasibility study was conducted in Denmark and the UK and used a controlled design to compare the intervention with usual care. Data on psychosocial and clinical outcomes were collected through questionnaires and electronic records. Furthermore, the study comprised interviews with adults with new-onset type 1 diabetes (n= 31) and healthcare professionals (n=9) who participated in the intervention. People were eligible for the study if they had been diagnosed with type 1 diabetes in adulthood ≥ 20 years and had received the diagnosis recently <nine months. We used data from the interviews to inform our development of initial programme theories. The interviews were conducted either in person, on the phone or virtually via Microsoft Teams within four months of the last consultation. The interviews focused on exploring participants’ experiences of participating along with their views on the acceptability, appropriateness, and feasibility of the intervention. This included the perceived fit, relevance or compatibility of the intervention to address psychosocial adaptation in adults with new-onset type 1 diabetes. The interviews were audio-recorded and transcribed verbatim. The feasibility study was approved by the Danish Data Protection Agency (VD-2018-196) and the North-West Preston Research Ethics Committee (22/NW/0053). All interview participants provided written informed consent before participation.

We conducted a secondary analysis of the interview data to further develop our initial programme theories. Our analysis was informed by a retroductive approach using both inductive and deductive logic (Wong et al., 2016). The approach involves moving back and forth between different types of reasoning to identify generative causality (Rees et al., 2025). Initially, we began coding the transcripts according to the initial programme theories that we had described based on the literature and the creative writing session. However, we found it challenging to differentiate between contexts, mechanisms and outcomes and found that we missed important insights about the context of the intervention. Thus, we decided to change our analytical approach and foreground the empirical material rather than the initial programme theories. In doing so, we read all transcripts to achieve an understanding of the content of the data. We then re-read a small sample of the transcripts to identify causal insights about the intervention including gaps in evidence. Following this, we extracted data according to the identified causal insights and drafted initial programme theories that corresponded to the data and the causal insights. Table 1 illustrates the analysis process. In accordance with Jagosh et al. (2024), we explored whether the extracted data aligned, disputed, or extended our initial programme theories. As such, we considered different rival theories to gain a deeper understanding of the mechanisms and contexts of the intervention. By developing sensitivity to rivalry, we were able to challenge our own assumptions about the intervention and identify important elements of context.

Table 1.

Example of Analysis Process

Informants	Transcript	Causal insights	Initial programme theory	CMO
People with diabetes	“I think it’s just some topics that maybe was somewhere on the back of my mind, but I wasn’t actually talking about those things […] I don’t want to be a burden to someone to speak about those.” (UK participant)	Topics were on the back of the mind	If the healthcare professional uses the Diabetes Roadmap or the Living with Diabetes tool in the consultation to visualise and normalise different aspects of life with diabetes, the person with diabetes will feel seen and encouraged to open up and verbalise thoughts, experiences and concerns in relation to diabetes. Furthermore, the person with diabetes will feel relieved and become aware of thoughts and experiences that otherwise had been hidden.	C: self-management support for adults with new-onset type 1 diabetes often revolves around physical aspects of diabetes. The person with diabetes may not be familiar with the course of treatment and is unaware of their potential need for psychosocial support. Healthcare professionals often prioritise knowledge provision rather than attending to the psychosocial aspects of diabetes.
	“I think probably being able to talk really openly about your feelings allows you to be more honest.” (UK participant)	Used to keep things to oneself		M: the person with diabetes feels seen and encouraged to open up and verbalise thoughts, experiences and concerns in relation to diabetes. The person with diabetes feels relieved and become aware of thoughts and experiences that otherwise had been hidden.
	“You start having open conversations and you don’t just kind of keep it to yourself in the beginning. That kind of sets the president going forward.” (UK participant)	Don’t want to be a burden		O: the person with diabetes recognises their reactions and feels prepared for experiences that may happen in the future. The person with diabetes feels confident in asking for support when needed.
	“It [using the dialogue tools] was like talking about a whole bunch of different perspectives on how I was really feeling. [I was] thinking about it without really putting it into words, so I really appreciated that. [When I left the clinic] I really felt relieved; as if a stone fell off my heart.” (DK participant)	Able to talk openly about feelings
	“I’ve been given so much information about how it [diabetes] physically affects you, how much [insulin] to take and many of those physical things. [Healthcare professionals] almost tried to carpet-bomb all that information from the start.” (DK participant)	Being honest about issues
		Feeling relieved
Healthcare professionals	“I think it [the dialogue tools] shapes your treatment in a much more holistic way away from the constant talk of numbers and management techniques; what I broadly considered the boring part of diabetes. I think it gives people an option to talk about stuff we very rarely cover really.” (UK participant)	The treatment becomes more holistic and less focused on numbers and diabetes management techniques	If the healthcare professional uses the Diabetes Roadmap or the Living with Diabetes tool in the consultation to visualise and normalise different aspects of life with diabetes, the person with diabetes will feel seen and encouraged to open up and verbalise thoughts, experiences and concerns in relation to diabetes. Furthermore, the person with diabetes will feel relieved and become aware of thoughts and experiences that otherwise had been hidden.	C: self-management support for adults with new-onset type 1 diabetes often revolves around physical aspects of diabetes. The person with diabetes may not be familiar with the course of treatment and is unaware of their potential need for psychosocial support. Healthcare professionals often prioritise knowledge provision rather than attending to the psychosocial aspects of diabetes.
	“It was so good that I had it [the dialogue tools in the consultation]. He [person with diabetes] just came up with all his concerns; something that you may never get to talk about if there wasn’t a dialogue tool.” (DK participant)	Facilitates conversation about psychological and social issues that would not otherwise be addressed in the consultation		M: the person with diabetes feels seen and encouraged to open up and verbalise thoughts, experiences and concerns in relation to diabetes. The person with diabetes feels relieved and become aware of thoughts and experiences that otherwise had been hidden.
	It [the consultation] becomes more open and broader and there are some topics on the tool that they [people with diabetes] otherwise wouldn’t think about [bringing up], and that I wouldn’t specifically ask them about. (DK participant)	Encourages people with diabetes to open up about concerns		O: the person with diabetes recognises their reactions and feels prepared for experiences that may happen in the future. The person with diabetes feels confident in asking for support when needed.
	“I think that the social and psychological part [of living with diabetes] takes up more space [in the consultation]; how they [people with diabetes] feel about things rather than merely how they do it [manage diabetes].” (DK participant)	Encourages people with diabetes to open up about concerns

Input From Stakeholders

Based on our analysis of the interview data, we sought feedback on our initial programme theories from various stakeholders. Doing so, we aimed to further refine the initial programme theories and enhance trustworthiness of our findings. We organised meetings with healthcare professionals delivering the intervention, a realist research peer support group, and the study advisory group. The advisory group consists of people with diabetes and healthcare professionals. As part of the advisory group, they are invited to provide feedback on the evaluation of the intervention and the implementation in clinical practice. In the meetings with the healthcare professionals and the advisory group, we introduced the realist evaluation approach and a few theory statements that the stakeholders could comment and reflect on. The participants had many questions about the realist evaluation approach and the formulation of theory statements. Consequently, we spent most of the first meeting discussing the benefits and challenges of using the realist evaluation approach rather than getting feedback on our theory statements. Thus, we decided to elicit their feedback in a different way. We selected two theory statements and introduced a mind map with the suggested statements (Figure 3). Then, we invited the participants to write down and discuss factors that may influence how the intervention works e.g., the approach of the healthcare professional and the time since the diagnosis. This was followed by a plenary discussion where we discussed barriers and facilitators related to our ideas about intended mechanisms and outcomes of the intervention. Based on the meetings with healthcare professionals and the advisory group, we summarised the input (Supplemental material 3) and presented some of our initial programme theories to a realist peer support group who commented on the description and formulation of programme theories. The process of soliciting input from various stakeholders directed our attention towards the contextual factors that promote or inhibit the mechanisms and outcomes of the intervention and inspired us to further develop and refine our initial programme theories.

Figure 3.

Example of mind map of suggested theory statements for discussions with stakeholders

Refinement and Prioritisation of Initial Programme Theories

In the final step of the process of developing programme theories, we combined insights from meetings with stakeholders, the creative writing session, and our analysis of data from the feasibility study of the intervention. In doing so, we compared the initial programme theories from our analysis of the data from the feasibility study with insights from the creative writing session and meetings with stakeholders and grouped the initial programme theories according to the suggested intervention mechanisms that we identified in the creative writing session. Then, we identified relationships between contexts, mechanisms and outcomes of the intervention and constructed CMO configurations. Finally, we categorised conceptually similar CMO configurations and prioritised the CMO configurations based on their correspondence with available data. To translate the CMO configurations into testable hypotheses about how the intervention may work, we constructed IF-THEN-BECAUSE statements for each category of initial programme theories. The IF-THEN-BECAUSE statements are formulated as IF (context), THEN (outcome), BECAUSE (mechanism).

Findings

The initial programme theories were grouped into the following ten categories (Figure 4).

Figure 4.

Categories based on the consolidation of CMOs

Assists the Healthcare Professional in Engaging in Conversations About Psychosocial Aspects of Diabetes

The healthcare professional may or may not recognise the importance of providing psychological and social support for adults with type 1 diabetes. This may depend on organisational barriers such as consultation time constraints, requirements set by clinical guidelines and an emphasis on blood glucose targets. Using the Diabetes Roadmap and the Living with Diabetes tool as part of the consultation can legitimise spending time on exploring psychosocial aspects of diabetes. Furthermore, training in therapeutic communication and facilitation skills can support the healthcare professional in exploring psychosocial aspects of diabetes. Thereby, the healthcare professional will feel confident in addressing psychosocial topics in the consultation. In addition, the person with diabetes will feel seen and open up to the healthcare professional. This will make the healthcare professional become aware of issues that are important to the person with diabetes and enable them to tailor their counselling accordingly. However, the healthcare professional’s ability to engage in conversations about psychosocial aspects depends on their communication skills, their participation in the communication training, as well as their use of and familiarity with the dialogue tools.

Context-Mechanism-Outcome Configuration

Healthcare Professional

IF healthcare professionals receive training in therapeutic communication that supports discussion of psychosocial aspects of diabetes, THEN they are more likely to tailor consultations to issues that matter to the person with diabetes, BECAUSE they feel capable and more confident in addressing psychosocial concerns.

Supports the Healthcare Professional in Adopting the Role of Facilitator

Healthcare professionals are often socialised into a biomedical approach and trained to be experts. This may shape their approach to providing psychological and social support. Providing training to support healthcare professionals in facilitating conversations about psychosocial aspects and including roleplay as part of the training will enable the healthcare professionals to try out the Diabetes Roadmap and the Living with Diabetes tool and support them in active listening. Thereby, the healthcare professional will put themselves in the shoes of the person with diabetes and reflect on their role in the consultation. As a result, the healthcare professional will recognise the applicability of the dialogue tools, get practical experience with using the tools and feel more confident in adopting the role of facilitator. Where healthcare professionals are trained to facilitate conversations about psychosocial aspects and the training includes group exercises and supervision, the healthcare professionals will feel seen and encouraged to share and reflect on common experiences and challenges in relation to the provision of psychological and social support. Doing so, they will feel more confident in adopting the role as facilitator and applying the Diabetes Roadmap and the Living with Diabetes tool as an integral part of their own practice. Healthcare professionals with previous experience of facilitating conversations about psychosocial aspects may find it easier to adopt the role of facilitator compared to healthcare professionals with limited experience. Experienced healthcare professionals may also be more prepared for addressing sensitive topics in the consultation.

Context-Mechanism-Outcome Configuration

Healthcare Professional

IF healthcare professionals receive group-based training in therapeutic communication, including supervision that supports reflection on their professional role and the perspective of the person with diabetes, THEN they are more likely to engage in conversations about psychosocial aspects and address sensitive topics in consultations, BECAUSE they come to see the dialogue tools as applicable to their own practice and feel confident in adopting a facilitating role.

Presents a Framework That Validates Conversations About Psychosocial Aspects of Diabetes

This initial programme theory focuses on the idea that the use of the Diabetes Roadmap and the Living with Diabetes tool as part of the consultation legitimises and creates time and space to discuss psychosocial aspects in the consultation. Thereby, the person with diabetes will experience that psychosocial issues are prioritised and feel confident in bringing up those issues. Furthermore, the healthcare professional will find it helpful to have a structure for the consultation which makes it easier to explore and address experiences and concerns of the person with diabetes. This will enable the healthcare professional to provide more person-centred care and involve the person with diabetes in the consultation. Furthermore, the focus on psychosocial issues in the consultation may foster a trusting relationship between the person with diabetes and the healthcare professional. However, if the healthcare professional experiences time constraints and does not validate the feelings of the person with diabetes, the person with diabetes may feel overlooked. For example, the healthcare professional may perceive the dialogue tools as an additional time-consuming task rather than a supportive intervention. Accordingly, the healthcare professional may be concerned about having enough time in the consultation to cover topics set by clinical guidelines. This may result in the healthcare professional feeling inadequate and doubtful about their ability to use the dialogue tools and provide psychological and social support. Furthermore, the person with diabetes may be reluctant to share their experiences with the healthcare professional, making it challenging to build a trusting relationship.

Context-Mechanism-Outcome Configurations

Healthcare Professional

IF healthcare professionals use the dialogue tools to structure consultations around psychosocial issues, THEN they are more likely to involve the person with diabetes and adapt the consultation to their needs, BECAUSE they recognise the need for a reorientation of the consultation towards what matters to the person with diabetes rather than predefined clinical agendas.

IF consultations are shaped by time constraints and guideline-driven requirements that emphasise biomedical targets, THEN healthcare professionals are more likely to focus on covering biomedical topics and deprioritise psychosocial aspects, BECAUSE they doubt their ability to use the dialogue tools and provide psychological and social support within the available time.

Person With Diabetes

IF healthcare professionals provide a clear structure for addressing psychosocial aspects in the consultation, THEN people with diabetes are more likely to share their experiences and concerns related to diabetes, BECAUSE they experience that psychosocial issues are legitimate topics and feel confident in raising them.

IF healthcare professionals deprioritise psychosocial aspects in consultations due to time constraints and guideline-driven requirements, THEN people with diabetes are more likely to feel overlooked and reluctant to share their experiences, BECAUSE the lack of acknowledgement and validation signals that their feelings are not relevant or welcome in the consultation.

Helps to Identify and Verbalise Thoughts and Experiences in Relation to Diabetes

The initial treatment and self-management support for adults with new-onset type 1 diabetes often revolves around physical aspects of diabetes and pays little attention to the emotional life of people with diabetes. Thus, the person with diabetes may not expect to bring up psychosocial issues in the consultation. By using the quotes and questions related to life with type 1 diabetes on the Diabetes Roadmap and the Living with Diabetes tool in the consultation to normalise different aspects of life with diabetes, the person with diabetes will feel seen and encouraged to open up. Using the illustration of a winding road and the three overlapping petals to visualise the complexity of adapting to a diagnosis of type 1 diabetes will also encourage the person with diabetes to verbalise thoughts, experiences and concerns in relation to diabetes. Thereby, the person with diabetes will feel relieved and become aware of thoughts and experiences that otherwise had been hidden. This will make the person with diabetes recognise their reactions and they will feel prepared for experiences that may happen in the future. In addition, the person with diabetes will feel confident in asking for support when needed. The healthcare professional will gain insight into the feelings, thoughts, and concerns of the person with diabetes and be able to tailor diabetes care to the individual needs of the person with diabetes. In addition, the healthcare professional will actively involve the person with diabetes in the consultation and the course of treatment. However, the level of empathy and positive regard demonstrated by the healthcare professional may affect the person’s willingness to share their feelings, thoughts, and concerns in relation to life with diabetes. In addition, some people do not have the vocabulary or ability to articulate what they feel.

Context-Mechanism-Outcome Configurations

Healthcare Professional

IF healthcare professionals show empathy and use quotes and questions from the dialogue tools to normalise different aspects of living with diabetes, THEN they are more likely to tailor diabetes care to the needs and priorities of people with diabetes, BECAUSE they recognise the importance of how the person with diabetes feels about their condition and gain insight into these aspects.

Person With Diabetes

IF a person with diabetes has not previously had the opportunity to talk about their emotions or is unable to articulate how they feel, THEN the quotes and questions on the dialogue tools can help them engage with and reflect on their thoughts and experiences, BECAUSE they feel seen and encouraged to verbalise what they are experiencing in relation to diabetes.

Enhances Understanding of the Connection Between Bio-Psycho-Social Aspects of Diabetes

The initial self-management education often revolves around physical aspects of diabetes. Furthermore, a biomedical discourse that diabetes can be controlled may reinforce the negligence of psychosocial issues and make the person with diabetes blame themselves for not managing diabetes “well enough”. By addressing the connection between bio-psycho-social aspects of diabetes, the consultations with the Diabetes Roadmap and the Living with Diabetes tool encourage the healthcare professional and the person with diabetes to recognise the complexity of living with diabetes. This will make the person with diabetes feel seen and heard. Furthermore, the person with diabetes will reflect on, articulate, and gain understanding of the interactions between thoughts, feelings, and behaviours in their life with diabetes. As a result, the person with diabetes will become less anxious about blood glucose levels and more compassionate towards their own efforts to manage diabetes. The healthcare professional will gain insight into the feelings, values, and beliefs of the person with diabetes and be able to tailor diabetes care to the individual needs of the person with diabetes. This may depend on the person’s willingness to share their experiences as well as their ability to articulate their feelings. In addition, the level of empathy and positive regard demonstrated by the healthcare professional may affect the person’s willingness to share their feelings and beliefs in relation to life with diabetes.

Context-Mechanism-Outcome Configurations

Person With Diabetes

IF the dialogue tools help a person with diabetes recognise the complexity of living with diabetes, THEN they will become willing and able to share their experiences, BECAUSE they develop an understanding of how thoughts, feelings, and behaviours interact in their life with diabetes.

IF a healthcare professional uses the dialogue tools to encourage a person with diabetes to share their experiences and normalise the complexity of managing diabetes, THEN the person will become more compassionate towards their own efforts, BECAUSE they feel seen and heard and recognise that managing diabetes is inherently complex.

Gives an Overview of and a Common Starting Point for the Process of Adapting to Diabetes

Being diagnosed with type 1 diabetes involves acquisition of a lot of information concurrent with getting new responsibilities for navigating the healthcare system. Furthermore, adults with new-onset type 1 diabetes need to adopt and maintain self-management skills. By illustrating and providing an overview of the course of treatment, the Diabetes Roadmap can provide clarity about the next steps. In response to this, the person with diabetes will know what to expect and feel reassured there is a plan for their care. Thereby, the person with diabetes will be prepared for the upcoming process and more confident in interacting with healthcare professionals. However, the ability to navigate the healthcare system may depend on their experiences with the healthcare system. Furthermore, being introduced to the next steps of care may be overwhelming for some, making them less receptive to information and less engaged in their future treatment course.

Context-Mechanism-Outcome Configurations

Person With Diabetes

IF a person with diabetes is unclear about what to expect in their care and has limited experience navigating the healthcare system, THEN they will feel prepared for the upcoming process, BECAUSE the Diabetes Roadmap clarifies the next steps, and the person feels reassured there is a plan for their care.

IF a person with diabetes is given a lot of information without consideration of their emotional responses, THEN they will be less engaged in their care, BECAUSE they feel overwhelmed.

Provides Understanding That Learning to Live With Diabetes is a Process

A biomedical discourse that diabetes can be controlled and that there is a certain endpoint of learning to live with diabetes may or may not make the person with diabetes feel that they must get everything right in a short space of time. By using the Diabetes Roadmap in the consultation to illustrate and normalise that learning to live with diabetes is a process, the person with diabetes will feel seen and understand that it takes time to get into new routines. In addition, the person with diabetes will feel less under pressure and relieved that there is time to learn and adapt. This will result in the person with diabetes becoming more compassionate towards themselves and confident in their abilities to manage diabetes. Moreover, the person with diabetes will become more open to try different ways of managing diabetes and learn through experience. The person’s knowledge of diabetes and experience with the healthcare system prior to their diagnosis may affect their adaptation to life with diabetes.

Context-Mechanism-Outcome Configuration

Person With Diabetes

IF a person with diabetes feels overwhelmed after diagnosis and believes they must get everything right immediately, THEN they will become more compassionate towards themselves and confident in their ability to manage diabetes, BECAUSE the Diabetes Roadmap illustrates that learning to live with diabetes is a process, helping them feel less pressured and reassured that there is time to learn and adapt.

Normalises and Signposts Experiences and Challenges in Life With Diabetes

Accommodating type 1 diabetes into life routines may lead to significant psychological and social challenges for the person with diabetes. This may include difficulties in coming to terms with the diagnosis, disruption of daily life, feeling alone with their feelings as well as feeling concerned about potential consequences of the diagnosis in terms of employment and social relationships. By using the examples on the Diabetes Roadmap tool as part of the consultation to normalise experiences and challenges in life with diabetes, the person with diabetes will recognise themselves in the examples and feel seen and less alone. Thereby, the person with diabetes will get a new perspective on their experiences and increase their awareness of the things that are going well. In addition, the person with diabetes will become more confident in their abilities to manage diabetes. Some people, however, may not recognise themselves in the examples on the Diabetes Roadmap. This may lead to the person with diabetes feeling distressed and out of place. Consequently, the person with diabetes may be reluctant to share their experiences with the healthcare professional.

By normalising and signposting experiences and challenges in life with diabetes, consultations with the Diabetes Roadmap and the Living with Diabetes tool can provide a new perspective on life with diabetes. In response to this, the person with diabetes will gain a greater understanding of the emotional and social impact of diabetes and feel more prepared for and hopeful about the future. Thereby, the person with diabetes will find it easier to accommodate diabetes into life routines and become more engaged in self-management practices. The process of adaptation may be more relatable for those who has experience with the healthcare system or know about diabetes before getting diagnosed with diabetes themselves.

Context-Mechanism-Outcome Configurations

Person With Diabetes

IF a person with diabetes is struggling to come to terms with their diagnosis and recognises themselves in the examples on the Diabetes Roadmap, THEN they will gain a new perspective on their experiences and become more confident in their ability to manage diabetes, BECAUSE they feel seen and less alone.

IF a person with diabetes finds it difficult to accommodate diabetes into their life routines and they engage with the dialogue tools, THEN they will become more involved in self-management practices, BECAUSE they gain a new perspective on the social and emotional impact of diabetes, helping them feel more hopeful about the future.

IF a person with diabetes does not recognise themselves in the examples on the Diabetes Roadmap, THEN they will be reluctant to share their experiences with the healthcare professional, BECAUSE they feel distressed and out of place.

Clarifies and Addresses Needs for Support

The initial diabetes self-management education often pays little attention to the emotional life of people with diabetes. Thus, the person with diabetes may or may not be expecting to express or is unaware of their needs and wishes for support in the consultation. By using the Living with Diabetes tool in the consultation to address social aspects of living with diabetes as well as the need for social support, the person with diabetes will reflect on and become aware of their needs and wishes for support. This will make the person with diabetes feel reassured and confident in requesting relevant support. Furthermore, the healthcare professional will gain insight into the support needs of the person with diabetes and be able to tailor diabetes care to the individual needs of the person with diabetes.

Family members often play a significant role in the care of their family member with diabetes but may have limited insight into how to best support their family member with diabetes. Furthermore, the person with diabetes may not wish to involve their family members in diabetes care. If the person with diabetes introduces the Diabetes Roadmap or the Living with Diabetes tool to their family members to illustrate and normalise the complexity of living with diabetes, the family members will gain a new perspective on the person with diabetes. This will result in the person with diabetes feeling reassured and confident in expressing their needs and wishes for support. In addition, the family members will become aware of and adapt to the support needs of their family member with diabetes. However, some family members may not be interested in discussing the experiences and support needs of their family member with diabetes. Consequently, they may not meet the support needs of their family member with diabetes.

Context-Mechanism-Outcome Configurations

Person With Diabetes

IF a person with diabetes is unclear about what to expect in their care or unaware of their needs and wishes for support and is exposed to the Living with Diabetes tool, THEN they will be able to express and request their support needs, BECAUSE the Living with Diabetes tool highlights the social aspects of living with diabetes and helps them recognise their own needs.

Family Members

IF family members are interested in using the dialogue tools to discuss life with diabetes and the support needs of the person with diabetes, THEN they will become aware of and adapt to those support needs, BECAUSE they gain a new perspective on the complexity of living with diabetes.

IF family members are not interested in using the dialogue tools to discuss the experiences of the person with diabetes or feel unable to meet their support needs, THEN conflict or disappointment may arise, BECAUSE expectations about discussing and responding to support needs are not met.

Addresses the Organisational Context of Implementation

As indicated above, organisational barriers such as consultation time constraints, requirements set by clinical guidelines and an emphasis on blood glucose targets can affect implementation of the Diabetes Roadmap and the Living with Diabetes tools. Therefore, it is important to consider the organisational context of implementing the dialogue tools and to support healthcare professionals in the implementation process. More specifically, this includes informing healthcare professionals about the intervention in advance, inviting them to provide feedback on the implementation process, and addressing potential challenges they may encounter during implementation. This will make the healthcare professionals feel prepared and motivated for using the dialogue tools. Accordingly, people with diabetes should be prepared for using dialogue tools prior to their consultation. Thereby, the person with diabetes will know what to expect prior to their consultation. In addition, there is a need to ensure that the IT system of the organisation is feasible for documenting the consultations. As there may be a limited number of adults with new-onset type 1 diabetes in the clinic, healthcare professionals may have limited possibilities for gaining experience with using the dialogue tools and feel doubtful about their ability to use the tools. However, the dialogue tools can be applied flexibly and adjusted to different settings. Thus, healthcare professionals can adapt the dialogue tools to their own practice and gain experience with using them. As a result, they will be more inclined to use them and apply them more consistently. Furthermore, the consistent use of the dialogue tools as part of the course of treatment may lead to adults with new-onset diabetes experiencing enhanced continuity of care.

Context-Mechanism-Outcome Configurations

Healthcare Professional

IF a healthcare professional finds it challenging to use the dialogue tools due to time restraints or clinical guideline requirements and is invited to provide feedback during the implementation process, THEN they will be more willing to use and adapt the dialogue tools to their own practice, BECAUSE they feel listened to and prepared to use them.

IF a healthcare professional has limited possibilities for gaining experience with the dialogue tools, THEN they will be less inclined to use the dialogue tools, BECAUSE they have limited experience with the dialogue tools and doubt their ability to use them.

Discussion

This study provides a practical example of developing initial programme theories for an intervention to support adults with new-onset type 1 diabetes. The initial programme theories contribute with important insights about contexts, mechanisms, and outcomes of the intervention. In line with previous studies (Fick & Muhajarine, 2019; Flynn et al., 2020), we encountered some challenges in the process of developing initial programme theories.

One of the challenges that we encountered was to describe the interactions between the intervention and the context. To address this challenge, we consulted the different stakeholder groups and revisited the literature about the development of the intervention. Furthermore, we relied on a study by Greenhalgh and Manzano (2022) which elaborates on different conceptualisations of context in realist research. Greenhalgh and Manzano (2022) suggest that context is conceptualised as relational and dynamic features that shapes the mechanisms through which the intervention works. For example, the intervention in this study is intended to support healthcare professionals in facilitating conversations about psychosocial aspects of diabetes, thereby affecting the interactions between people with diabetes and healthcare professionals. At the same time, the experience of the healthcare professional in terms of facilitating dialogue about psychosocial aspects may shape how the intervention is applied and perceived. As such, the experience and competencies of the healthcare professional can function as both a mechanism and a context. In addition, organisational structures such as clinical guidelines and procedures in diabetes care may affect the healthcare professional’s ability to facilitate conversations about psychosocial aspects. Thus, the intervention operates at multiple levels of social systems. However, the initial programme theories in this study do not necessarily capture the interactions between the individual consultations and the wider clinical context. This includes e.g. how clinical workflows and perceptions of professional roles affect the intervention (Sørensen et al., 2020). Consequently, these aspects require further exploration in the realist evaluation of the intervention. In addition, it is essential that the realist evaluation explores how the relationship between the person with diabetes and the healthcare professional shapes the intervention e.g. the importance of trust. For example, research has shown that a trusting relationship between the person with diabetes and the healthcare professional can encourage the person with diabetes to discuss sensitive topics (Hendrieckx et al., 2021).

Another challenge that we encountered was using and combining the different data sources to develop initial programme theories. We addressed this challenge by demonstrating reflexivity in the process of developing initial programme theories. This includes recognising how the assumptions and liabilities of the research team and the key stakeholders influence the research process (Downey et al., 2024). As our research team included key stakeholders who had been involved in developing and feasibility testing the intervention, we were able to quickly get a comprehensive overview of relevant literature related to the intervention. However, this approach may involve a risk of confirmation bias. To address this challenge, we conducted a creative writing session where we discussed our assumptions about the intervention and developed rival theories. In line with this, Jagosh et al. (2024) suggest contrasting initial programme theories with rival theory statements illustrating how the same intervention can trigger different responses. Furthermore, we received input from stakeholders who had not been involved in developing the intervention which enabled us to challenge our assumptions about the intervention. However, one challenge in engaging stakeholders was to introduce them to the realist approach and present initial programme theories. In this regard, we struggled to present the programme theories with sufficient detail to reflect the intervention yet avoid being too specific as this could cause confusion. Furthermore, we experienced that the involvement of diverse stakeholders required us to adapt our approach depending on the stakeholder group. Accordingly, Malengreaux et al. (2024) suggest that researchers tailor the stakeholder involvement strategy to the individual stakeholder group. In our study, we used realist terminology with the realist peer support group and applied a more open approach with healthcare professionals and people with diabetes. For example, we used visual aids such as mind maps to support reflection and discussion of theory statements. Using visual aids as means to engage stakeholders in the development of programme theories has also proved to be beneficial in other studies (Fick & Muhajarine, 2019; Griffiths et al., 2022). In addition, it was an advantage that the facilitator of the meetings had been involved in developing and feasibility testing the intervention as she could spot opportunities to ask further questions and drill into ideas before the conversation had moved on. However, there is a risk that the participating stakeholders may have been less likely to share critical perspectives on the intervention. To address this issue, we encouraged the stakeholders to reflect on factors that could either promote or inhibit the effects of the intervention. This exercise also allowed the stakeholders to reflect on the intervention beyond their own setting. In line with this, Malengreaux et al. (2022) highlight the need to consider the involvement of stakeholders as a participatory practice to develop a common understanding of the intervention rather than merely a means for building evidence about the intervention.

The initial programme theories that we have developed as part of this study are intended to guide the realist evaluation of the intervention. For example, they have informed the development of interview guides for people with diabetes and healthcare professionals. The input that we got from stakeholders not only informed the construction of programme theories, but also provided vital insights about the implementation of the intervention. This included organisational aspects of implementation such as documentation of the consultations and the healthcare professionals’ opportunities to gain experience with using the dialogue tools. This knowledge can be used to understand how the intervention might be adapted to fit within different contexts. Accordingly, Greenhalgh and Manzano (2022) suggest that the task of realist evaluation is to explore how an intervention might work differently in different contexts rather than to identify and reproduce the ‘ideal’ contextual conditions for implementing the intervention.

In this study, we used exploratory data from a feasibility study of the intervention to inform the development of initial programme theories. Doing so, we combined an exploratory approach to data generation with a realist evaluation approach to analysis. Realist evaluation and exploratory approaches often rely on different philosophical assumptions which have implications for data generation and analysis (Moore & Kelly, 2024). Despite these differences, we would argue that the approaches complemented each other in this study. While the exploratory approach allowed us to gather rich descriptive insights about how the intervention was experienced, the realist evaluation perspective provided a deeper understanding of the generative causes that informed and shaped the participants’ experiences of the intervention. Thus, the realist evaluation perspective offered an essential framework to explore causal mechanisms of the intervention which might be applicable in similar interventions.

Reflecting on the process of developing initial programme theories, we have the following recommendations for practice. We suggest involving different stakeholder groups in programme theory building and to adapt the approach according to the different groups. Furthermore, we encourage using visual aids to engage stakeholders in programme theory building. We also suggest using exploratory qualitative data to construct and refine programme theories as it can provide vital insights that can contribute meaningfully to the construction of programme theories. In the next phase of the study, we will apply realist principles to the data collection to further explore connections between context, mechanisms, and outcomes of the intervention.

Supplemental Material

Supplemental Material - Developing Initial Programme Theories for a Realist Evaluation of an Intervention to Support Adults in Adapting to Life With Type 1 Diabetes: Methodological Insights and Implications for Practice

Supplemental Material for Developing Initial Programme Theories for a Realist Evaluation of an Intervention to Support Adults in Adapting to Life With Type 1 Diabetes: Methodological Insights and Implications for Practice by Regitze Anne Saurbrey Pals, Bryan Cleal, Angus Forbes, Mette Due-Christensen in International Journal of Qualitative Methods

Supplemental Material

Supplemental Material - Developing Initial Programme Theories for a Realist Evaluation of an Intervention to Support Adults in Adapting to Life With Type 1 Diabetes: Methodological Insights and Implications for Practice

Supplemental Material

Supplemental Material - Developing Initial Programme Theories for a Realist Evaluation of an Intervention to Support Adults in Adapting to Life With Type 1 Diabetes: Methodological Insights and Implications for Practice

Footnotes

Acknowledgements

The authors would like to thank the advisory group of the realist evaluation, the realist research peer support group and the healthcare professionals who were involved in the study.

ORCID iDs

Regitze Anne Saurbrey Pals

Mette Due-Christensen

Ethical Considerations

The feasibility study was approved by the Danish Data Protection Agency (VD-2018-196) and the North-West Preston Research Ethics Committee (22/NW/0053). The studies complied with the Helsinki Declaration.

Consent to Participate

Interview participants provided written informed consent before participation.

Author Contributions

Regitze Anne Saurbrey Pals and Mette Due-Christensen conceptualised the study, analysed and interpreted the data. Regitze Anne Saurbrey Pals drafted the manuscript and Mette Due-Christensen, Bryan Cleal and Angus Forbes critically reviewed the manuscript for important intellectual content. All authors approved the final version of the manuscript.

Funding

The authors received no financial support for the research, authorship, and/or publication of this article.

Declaration of Conflicting Interests

The authors declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Data Availability Statement

The data are available, but restrictions apply to the availability of these data, which were used under the license for the current study, and so are not publicly available. However, data are available from the authors upon reasonable request.*

Supplemental Material

Supplemental material for this article is available online.

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