Protocol of Process Evaluation of Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA)Trial

Abstract

Background and aims

Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT India) is a complex intervention delivered across 30 centres in 16 Indian states. The study delivers intervention in 12 languages in the form of workbook, videos and short messaging using cellular device and internet as a tool. Objectives of process evaluation are to assess whether trial was implemented as planned (fidelity and dose); whether, how and why the intervention is effective by looking at the stakeholders’ experiences (effectiveness); to assess reach of intervention in population (reach); how intervention fits into treatment plan to cause behavioural change when adopted (adoption); usefulness for target population and bring behaviour change (maintenance).

Methods

SPRINT India process evaluation is a prospective, multicentre study conducted with mixed-methods approach. Sample size of centres and stakeholders will be selected by maximum variance purposive sampling strategy. Centres will be stratified primarily for representing the 11 regional language in which the intervention is delivered. Qualitative data will comprise of interviews of patients, care givers and health professionals at these centres using semi structured interview guide. Quantitative data will comprise of all the randomised patients. Process evaluation framework is based on Realist and RE-AIM evaluation models presented according to Medical Research Council’s guidance. The four sections of the framework are context, trial implementation, mechanisms of impact and trial outcomes.

Results

Interviews of approximately 100 stakeholders and focus group interviews of health professionals and SPRINT India study central coordinating staff will be conducted. Analysis will be done using triangulation methodology. It will incorporate use of both quantitative and qualitative data, data collection techniques, data sources, evaluation models, stakeholders and researchers.

Conclusions

Process evaluation will identify efficacious factors in intervention package and consolidate use of secondary stroke semi-interactive stroke prevention package into practice and policy to prevent recurrent stroke.

Keywords

secondary prevention stroke evaluation mixed-methods framework internet

Introduction

Stroke incidence and mortality have reduced in high-income countries over the last 50 years while recurrent stroke is still prevalent globally (Khanevski et al., 2019). Various studies have established that the stroke recurrence rates vary from 7%–20% at 1 year to 16%–35% at 5 years (Edwards et al., 2017). Stroke occurs on an average 10 years earlier in India in contrast to many countries and recurrent stroke and coronary heart disease largely cause 60% mortality in stroke patients in the first year (Edwards et al., 2017; Ray et al., 2013; Sylaja et al., 2018; Yeo et al., 2017). Nearly 60% of all strokes happen in population under the age of 70 each year, out of which 8% of strokes happens under 44 years of age (Lindsay et al., 2019). Non-compliance to medications and non-adherence to stroke prevention treatment is present in 30–50% of patients (Al AlShaikh et al., 2016; Bushnell et al., 2011; Perreault et al., 2012). A blueprint for delivering quality stroke treatment and several action plans have been proposed to eliminate disparities in stroke care, with an emphasis on the significance of using novel, culturally adapted and context-specific strategies (GBD 2019 Stroke Collaborators, 2021). The use of mobile technology, for example, is part of a mix of stroke preventive strategies (Pandian et al., 2018). The booming use of mobile phones around the world including low- and middle-income countries, offers a lot of promise for its usage especially in areas where health care is scarce (Pandian et al., 2018). India has a high mobile phone presence with affordable internet packages (‘BBC’, 2019; ‘Statista’, 2021a; ‘Statista’, 2021b). Furthermore, it has been illustrated in community-based preventive interventions that e-health can help in addressing the lack of knowledge of stroke, its risk factors and treatment (Sureshkumar et al., 2016; Srinivasapura Venkateshmurthy et al., 2019).

‘Secondary Prevention By Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA)’ trial was the first trial to be initiated in 2017 in the Indian Stroke Clinical Trial Network (INSTRuCT) established under the aegis of Indian Council of Medical Research. (Pandian et al., 2021). SPRINT India is a randomised controlled trial, parallel design, adaptive and blinded end-point clinical trial of sub-acute stroke patients initiated with the aim to reduce recurrent stroke, acute coronary syndrome and deaths in patients (Kate et al., 2020). Intervention is provided in the form of Short Messaging Services (SMS), video messages and educational workbook delivered over a period of one year (Kate, Arora et al., 2020; Kate, Verma et al., 2020). SPRINT India study intervention algorithm is presented in the published SPRINT India research articles (Kate, Arora et al., 2020; Kate, Verma et al., 2020). The intervention underwent a rigorous formative process from March 2017 to March 2018 to develop the SMSs, patient workbook and short duration videos in English (Kate, Arora et al., 2020; Kate, Verma et al., 2020). The intervention was translated into 11 Indian languages with the help of stakeholders and language experts to maximise its reach in the target population (Kate, Arora et al., 2020; Kate, Verma et al., 2020). Acceptability stage meetings were held for all the Indian languages at the centres where the language is primarily spoken. After undergoing formative and acceptability stage, the intervention was implemented in all the 30 centres, both government and private, across the 16 states in the country after receiving the ethics approval (Kate, Arora et al., 2020; Kate, Verma et al., 2020).

The SMS and videos are sent as a message link to which patient/caregiver gives a missed call to the embedded toll free number which is then saved by the system (Kate, Arora et al., 2020; Kate, Verma et al., 2020). Patients with aphasia, hemianopia and illiterate patients are also recruited with the help of primary caregiver being responsible to read and acknowledge the receipt of messages and videos (Kate, Arora et al., 2020; Kate, Verma et al., 2020). Contamination of intervention is avoided by explaining about the confidentiality and copyright of the patient education material and obtaining the informed consent (Kate, Arora et al., 2020; Kate, Verma et al., 2020). The patients are followed up at 6 months and 1 year (Kate, Arora et al., 2020; Kate, Verma et al., 2020). The primary outcomes are high risk transient ischaemic attack, acute ischaemic stroke, intracerebral haemorrhage, acute coronary syndrome and death at one year. (Kate, Arora et al., 2020; Kate, Verma et al., 2020).

There is an inherent element of evaluation in the SPRINT India RCT with the incorporation of the Case report form ‘Patient Feedback Questionnaire’ and the inclusion of patient diary in the workbook which has sections dedicated to all the 3 interventions for the patients to write and reflect on their learning experience and provide feedback. This method of critical realist evaluation is acquired out of critical realism (Quintans et al., 2020). The SPRINT India intervention is diverse and has complex interplaying components. SPRINT India Trial process evaluation (PE) will evaluate the various varied complex facets of the intervention presented through the new model. The document describing the updated Medical Research Council framework presents complex intervention as one which has numerous characters and the outcomes are produced due to external determinants like receiver attributes and the context across which it is applied (Skivington et al., 2021).

Hence it is imperative to have knowledge of the key variables which influence the intervention. A PE using both qualitative and mixed-methods designs is crucial for assessment in this kind of complex research for resolving questions past effectiveness (Skivington et al., 2021). PE is conducted to enlighten findings to provide insight into why an intervention misses unanticipatedly, or why an intervention achieves and how it can be furthered. This includes exploring the fidelity and quality of the intervention, clarifying causal mechanisms and identifying contextual factors associated with variation in the outcomes (Skivington et al., 2021).

A promising recommendation is to perform a realist evaluation in order to understand the effectiveness of the intervention elements instead of only the intervention as a composite; comprehend the mechanisms which bring change and assess the rationale of the context of the intervention in its entirety. A realist evaluation is based on theory driven by the question ‘what works for whom and under what circumstances’, which helps to realistically explore the mechanisms involved and their interplay with context (Bonell et al., 2012). This theory is derived from an understanding of the varied composite social and organisational context underlying the intervention, which is essential to develop hypothesis to describe why interventions are beneficial in some cases but not in others (Dalkin et al., 2021). We believe that RCTs like SPRINT India can allow for thorough inspection of context and mechanisms whilst allowing for an evaluation of causal pathways due to incorporation of inherent process evaluation checks. A realist strategy will be needed to identify insights with respect to contexts, mechanisms and outcomes of the SPRINT India intervention into routine stroke practice (Dalkin et al., 2021). This will include collection, analysis and evaluation of qualitative and quantitative data with the goal of developing and verifying intervention programme theories and providing understanding into the role of context on the intervention’s influence (Skivington et al., 2021). This should result in real awareness of how and which intervention component will achieve the outcomes and under what circumstances (Fisher, et al., 2021).

The SPRINT India trial randomised first patient on April 28th, 2018 and has recruited 4298 patients as of 15th November 2021. SPRINT Trial is the first RCT, in India with 30 centres with distinctive 3 pronged semi-interactive intervention using the cellular device and internet as a tool. The other unique element of the trial is that the intervention is being delivered in culturally appropriate 11 Indian languages. The PE will probe the scope of the generalisability of the intervention and help elucidate whether the SPRINT trial was implemented as planned, inform who, how and why the intervention had a specific effect and identify key obstacles and facilitators to its implementation.

The objectives of the SPRINT India PE are as follows: (1) To assess whether the SPRINT trial was implemented as planned (fidelity and dose); (2) To determine whether, how and why the intervention is effective by looking at the stakeholders experiences (effectiveness); (3) To assess the reach of the intervention in population (reach); (4) How does intervention fit into the treatment plan to cause behavioural change and which intervention was more effective when adopted (adoption) and (5) To find out practically, the convenience and usefulness of the intervention for the target population and bring an actual behaviour change over time (maintenance).

Material and Methods

Study Design and Study population

The PE of SPRINT India is a prospective multicentre study which will be performed at 11 hospitals.

a. Inclusion Criteria: SPRINT India Trial randomised patients with their care givers, SPRINT India Trial health professionals and stroke staff at the centres.

b. Exclusion Criteria: SPRINT India Trial participants who have withdrawn their consent.

Process evaluation Models and Hypothesis Framework

The SPRINT India trial PE is based on the Realist and RE-AIM evaluation models with a pragmatic approach. The realist model is established on realism-based hypothesis for the specific context involving both qualitative and quantitative components (Quintans et al., 2020). The characteristics of the environment and setting under which the treatments were implemented represent the context (Quintans et al., 2020). The SPRINT India PE theory has been described and will be further refined into the contexts, mechanisms and outcome elements and tested through data gathering in order to achieve the study’s objectives (Fisher, et al., 2021). The evaluation questions have been specifically prepared with regards to the pivotal aspects of the developed hypothesis. Largely quantitative approaches will be utilised in reference to the context and qualitative methods will aid in the examination of hypotheses as well as the uncovering of unintended contextual factors and outcome elements (Quintans et al., 2020). In this way, the semi structured interviews and other data collection techniques will be modelled into context–mechanisms–outcome (CMO) combinations to explain the causal sequence correlations with hypothesis and facets that influenced the outcomes (Quintans et al., 2020). The purpose is to extract extensive, qualitative data in order to determine facilitators and barriers to intervention implementation and performance (Bonell et al., 2012). Accordingly, in the analysis, various outcome patterns will emerge for different groups or contexts herein the evaluation (Quintans et al., 2020). The model emphasises on the structural elements – mechanism and context to analyse the influence of social behaviours and organisational sector to determine ‘what works, for whom, in what context, and how’ (Quintans et al., 2020).

The RE-AIM model is established on elements – reach (R), effectiveness (E), adoption (A), implementation (I) and maintenance (M), to assess long-term efficacy for both the organisational sector and the target subjects (Glasgow et al., 2019). Taking a pragmatic approach, both models will provide guidance factoring the relevant aspects of the evaluation objectives, context, organisational sector and target subjects. Strategies will be characterised with the context and linkages explored across the implementation approaches and their outcomes. Implementation variable – fidelity will determine intervention delivered comprehensively past various tiers of organisation to its stakeholders and adaptations will determine the questions ‘who, what, why, where, and when’. (Glasgow et al., 2019) Mixed-methods data collection will probe the causal mechanisms for the RE-AIM components by qualitative approach to grasp ‘what happened, how and why’. (Glasgow et al., 2019)

Process evaluation framework design and its rationale

SPRINT India framework (Figure 1) is designed according to the Medical Research Council’s process evaluation guidance (Moore et al., 2015). The framework is organised into four elements: context, trial implementation, mechanisms of impact and trial outcomes. Context, implementation and mechanisms of impact are derived from intervention and presented in coloured frames and fit questions based on the RE-AIM and REALIST models. The evaluation framework is clearly outlined and illustrated to project what it includes and involves; who the subjects are, who delivers it, the geographical coverage and the expected outcomes, among other things in line with the above models (Quintans et al., 2020).

Figure 1.

SPRINT INDIA process evaluation framework.

Outcomes will be interpreted using these elements, guided by the principal hypotheses of the SPRINT India intervention. The data collection tools used to meet the objectives are also presented in the framework.

Tools used to meet the objectives of the PE and the mixed-methods:

1. To assess whether the SPRINT India trial was implemented as planned (fidelity and dose) – Quantitative data sets like the Screening Logs and Case Report Forms from electronic case records, missed call acknowledgement data, questionnaires for capturing acknowledgement of SMS and Video receipt for intervention arm, questionnaire for capturing intervention contamination for control arm, workbooks filled and returned by the patients with their feedback. The questionnaires for capturing acknowledgement of intervention, contamination and filled workbook information are being captured on Google sheets for patients by the centre coordinators. The patient’s perceptions in these Google sheets have been coded in a Likert scale and thus ‘quantitising’ of qualitative data is done for quantitative analysis (Gaglio et al., 2014; O’Cathain et al., 2010).

2. To determine whether, how and why the intervention is effective by looking at the stakeholders’ experiences (effectiveness) – Qualitative in-depth interviews of patients, caregivers, health professionals and a neutral stroke unit staff with the help of semi structured questions from the interview guides emphasise on obtaining answers to the PE objectives. Interview of a neutral, stroke unit staff not associated with SPRINT India from each sample centre will provide understanding of the context of the organisation’s secondary stroke prevention strategies. Individual stakeholder insights on the mechanisms associated with the implementation, delivery and impact of the secondary stroke awareness intervention, and their connect to contextual facets and intended outcomes, will be examined via realist interviews (Fisher et al., 2021).

Semi-structured interview guides have been developed in English and prepared for patient, caregiver and health professional separately. The interview guides have been pilot tested on two Hindi speaking patient caregiver duos after obtaining their consents. After the pilot testing interview guides were further fine-tuned to meet the objectives of the study and made more incisive.

3. To assess the reach of the intervention in population (reach) – The screening logs obtained from each centre from the electronic case records and the qualitative interviews.

4. How does intervention fit into the treatment plan to cause behavioural change and which intervention was more effective when adopted (adoption) – The qualitative health professional and neutral stroke unit staff in depth interviews will elucidate adoption from the organisational context and in-depth interviews of patients and their caregivers from the target subjects’ perspectives.

5. To find out practically, the convenience and usefulness of the intervention for the target population and bring an actual behaviour change over time (maintenance) – The qualitative in-depth interviews of the stakeholders and Case Report Forms from electronic case records.

Sample size

Centres: The primary stratification of centres for qualitative interviews are based on the 11 languages in which intervention was translated and acceptability amongst stakeholders was checked. These languages were used to prepare intervention according to the feasibility data obtained from patient subgroups at the SPRINT India centres initially in 2017. We recognise that the context of the evaluation would be found lacking without stakeholder representation using all the Indian intervention languages. Centres will also be stratified for private and government hospitals, north and south Indian hospitals and older and newer centres added to the trial over the years. SPRINT India centres and PE sample centres with their languages are presented in Figure 2.

Figure 2.

SPRINT INDIA centres and Process Evaluation centres with their languages.

Stakeholders: A sample of 3–4 patient, care giver dyads, who have either completed or completing 1 year of intervention will be interviewed from each centre following a maximum variance purposive sampling strategy for age, gender, treatment group, region and modified Rankin Scale. Accordingly, in depth interview of 2–3 health professionals, that is, the principal investigators, centre coordinators and neutral health professional like a stroke nurse/physiotherapist/occupational therapist/speech therapist/physician assistant) individually will be done per sample centre. Focus group interviews of the INSTRuCT Network, Central Coordinating Centre (CCC) team and health professionals will also be performed. A projected 100–130 in depth interviews will be performed. An effort to interview those patients who did not allow follow-up in the trial, due to any reason will also be done to identify the barriers.

Sample Recruitment and Study Organisation

The INSTRuCT Network, CCC comprises of JDP, the Principal Investigator (PI) with Information Technology (IT) personnel, two National Coordinators (SJV and DA), one Statistician and Research Associate (AD). (Pandian et al., 2021). The primary responsibility of the PE will lie with SJV. She will train, direct and manage the CCC team and conduct personal qualitative sessions to prepare them to conduct the interviews at the centres. The qualitative interviews in the south Indian languages (Tamil, Telugu, Malayalam and Kannada) will be conducted by AD. The qualitative interviews in the north Indian languages (Hindi, Bengali, Assamese, Marathi, Gujarati, Oriya and Punjabi) will be conducted by SJV and DA. SJV will also conduct focus groups interviews with the Indian Council of Medical Research officials, CCC team members and trial investigators about barriers and facilitators to trial implementation.

A list of eligible patients satisfying the sampling parameters will be e-mailed to the centres a few days prior to the visit to call and invite the patient caregiver duos for interview on the scheduled date. If the duo is not willing to participate, where possible, effort will be made to know the reason. The health professionals of each centre will be invited via email or in person to participate in interviews, which will be conducted in English. After obtaining written informed consents, interviews will be conducted separately for each stakeholder.

Interviewing patient and caregiver individually has the advantage of eliciting opinions that would not be obtained if the other was present. Efforts will be made to conduct in person interviews as per the COVID pandemic guidelines or adapted to be held via telephone call, according to the COVID pandemic situation. Telephonic informed consent forms have also been developed for the same and have received ethics approval at all the PE sample centres.

The centre would also be requested to arrange an interpreter; preferably a researcher working with the sample hospital but not involved with the SPRINT INDIA trial to reduce bias. It will be ensured that the interpreter is well versed in the regional language and familiar with the local cultural background. Prior to the visit, a ZOOM meeting will be scheduled with the interpreter and provided training in relevant aspects of SPRINT INDIA intervention and the PE objectives, usage of the interview guide, conducting the interview and also acquaint them with the visiting CCC personnel.

Analysis

Triangulation methodology will be incorporated with the use of quantitative and qualitative data, different data collection techniques, multiple data sources, the two theoretical frameworks – Realist and RE-AIM, sampling from various viewpoints and multiple researchers. For each case, collected data will be analysed separately, yielding two sets of findings (O’Cathain et al., 2010). The researchers will then seek to combine their findings, a method known as triangulation (O’Cathain et al., 2010). The triangulation method of carrying out PE utilising multiple methods, as mentioned above, will present a more comprehensive overview of the secondary stroke prevention intervention. Thematic analysis will be used to code the data to build themes across the sub elements of this process evaluation framework for the qualitative analysis (Patton, 1999). In tandem with being a realist evaluation, the study hypothesis and corresponding elements of context–mechanism–outcome will be used as the reference point. Subsequently, data will be analysed in a continual, hierarchical manner with contrasting of data sources in order to recognise standard and noteworthy themes (Fisher et al., 2021; Patton, 1999).

The perspectives of patient, caregiver, and health professional and quantitative data from each site will be analysed to correlate links between contexts, mechanisms and outcomes. (Fisher et al., 2021). Depending on the mechanisms and contextual parameters, the realist evaluation will provide a rationale for the outcome patterns. Various outcome patterns are expected to appear for various groups or contexts within the confines of PE of the intervention. It could reveal if a particular intervention component works independently of others, how intervention is implemented in differing styles, whether it is more potent with a few groups, if it is being used more at one site over another, how intervention can have both premeditated and unforeseen consequences and if the impact is expected to endure (Quintans et al., 2020).

Interviews will be audio recorded, professionally translated and transcribed verbatim in English. Quotes will be extracted from audio recordings and entered in qualitative NVivo software (O’Cathain et al., 2010). The availability of both qualitative and quantitative data on the same cases is a unique feature of mixed-methods investigations. At the analysis, data from the qualitative and quantitative components will be combined, and subset of cases built, for which both Case Report Forms and the transcript will be essential (O’Cathain et al., 2010). For example, asking ‘Are you taking physical activity regularly? Has there been more regularity or is it the same over time?’ can be corroborated from the Case Report Form from the same case. Hence, contrasting stakeholder’s opinions to semi structured interview guide with their interview transcript, the data can be reviewed in depth for each case. To triangulate the budding themes, relevant data from observations and other quantitative data will be employed (Zhang & Creswell, 2013).

Other forms of triangulation to improve the reliability of results include sampling from various viewpoints, such as patient, caregiver, neurologists, neutral health professionals and centre coordinators, and the triangulation of different researchers in the team who each contribute their distinct cultural influences and academic experience (Patton, 1999). The different techniques employed include the capturing of information through case report forms, interviews and Google sheets. The framework will serve as a master plan for combining these insights. This means that the continual study of the process evaluation results would improve our decipherment of the intervention’s causal mechanisms.

The quantitative data will be summarised using frequency distribution and descriptive statistics. The continuous variable (ratio) will be represented as Mean (SD) and categorical variables (nominal) will be represented as Count (percentage). All the randomised patient’s responses collected using intervention receipt questionnaire, intervention contamination amongst control arm questionnaire, patient’s baseline and feedback data from electronic case record forms will be analysed using SPSS version 26.0.

Ethical approval and Reporting of PE Outcomes

The PE of the SPRINT India study ordained the amendment to the SPRINT India protocol and Ethics Committee approvals at all the centres. The Informed consent forms for both written and telephonic interviews for the patients, caregivers and health professionals and the semi structured interview guidelines in the study have received approvals at the sample centres.

The main results of the SPRINT India PE will be published by approval from the INSTRuCT Steering Committee with appropriate authorship determined by the steering committee and as per International Committee of Medical Journal Editors (Pandian et al., 2021). The corresponding author would specify the chosen citation, correctly identify all individual authors and list additional group members in the acknowledgements (Pandian et al., 2021).

Discussion

Our process evaluation intends to augment a thorough evaluation of the trial’s outcomes by enlightening our stakeholders on how, for whom, and why this secondary stroke awareness model can be useful. The use of mixed-methods data collection will probe causal mechanisms for the Realist and RE-AIM models to grasp ‘what happened, how and why’.

Complex interventions are context-dependent, which means their performance will be influenced by variables including socio – cultural, economic and environmental factors, organisational capability, policies and core demographics (Bonell et al., 2012). This can be due to differences in existing levels of organisational structure to implement and gain rewards from complex interventions, as well as the fact that such initiatives frequently have long causal chains that perform in different ways in different circumstances (Bonell et al., 2012).

Discontinuation of secondary preventive treatment due to a variety of socio demographic variables leads to increased recurrence and disabilities among stroke patients (Das et al., 2010). The evaluation of the process of the SPRINT India study will help to explain that when a novel approach to spread secondary stroke awareness is practiced for a large sample group, do all the cogs in the machinery of implementation, work as planned according to the protocol. The power and reach of mobile and internet technology in delivering complex interventions presented in entertaining and unique way needs exploration in developing countries. Evaluation of the various varied complex facets of the intervention presented through this new model will help demystify all the methods and mechanics involved. Key obstacles and facilitators to intervention implementation will also be identified.

We will be able to ascertain the factors efficacious in semi structured stroke intervention package and help consolidate the stroke secondary prevention awareness into practice and policy for the stroke treatment plan to prevent recurrent stroke and cardiovascular events. The PE of the semi-interactive secondary stroke awareness is essential to probe the scope of the generalisability of this intervention. The evaluation of the intervention will accredit the policymakers with knowledge that how the measures will have varied effects in different situations and to decide upon the identified recommendation of intervention to be adopted under specified conditions.

Summary and Conclusion

SPRINT India PE findings will explore the perspectives of the involved stakeholders and actual issues across various contextual backgrounds for authorities to decipher the real picture regarding secondary stroke prevention and use of internet as a tool. Our process evaluation intends to present a thorough evaluation, with the mixed – methods process, of the trial’s outcomes by enlightening the context, developed intervention, its implementation and mechanism of impact.

Supplemental Material

sj-pdf-1-ijq-10.1177_16094069221093139 – Supplemental Material for Protocol of Process Evaluation of Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA)Trial

Supplemental Material, sj-pdf-1-ijq-10.1177_16094069221093139 for Protocol of Process Evaluation of Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA)Trial by Shweta J. Verma, Puja Gulati, Himani Khatter, Deepti Arora, Aneesh Dhasan, Meenakshi Sharma, P. N. Sylaja and Jeyaraj D. Pandian in International Journal of Qualitative Methods

Footnotes

Declaration of Conflicting Interests

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

Funding

The author(s) disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: Structured Semi-Interactive stroke prevention package in India (SPRINT India) study has received grant from Indian Council of Medical Research, New Delhi (Grant number: SWG/Neuro/30/2017-NCD-I).

Correction (September 2024):

Article updated to correct affiliation of the corresponding author.

ORCID iDs

Shweta J. Verma

Himani Khatter

Deepti Arora

Aneesh Dhasan

Meenakshi Sharma

Padmavathyamma Narayanapillai Sylaja

Jeyaraj D. Pandian

Supplemental Material

Supplemental material for this article is available online.

References

Al AlShaikh

Quinn

Dunn

Walters

Dawson

(2016). Predictive factors of non-adherence to secondary preventative medication after stroke or transient ischaemic attack: A systematic review and meta-analyses. European Stroke Journal, 1(2), 65–75. https://doi.org/10.1177/2396987316647187

BBC . (2019). Mobile data: Why India has the world’s cheapest. https://www.bbc.com/news/world-asia-india-47537201 Retrieved May 28 2021

Bonell

Fletcher

Morton

Lorenc

Moore

(2012). Realist randomised controlled trials: a new approach to evaluating complex public health interventions. Social Science & Medicine (1982), 75(12), 2299–2306. https://doi.org/10.1016/j.socscimed.2012.08.032

Bushnell

C. D.

Olson

D. M.

Zhao

Pan

Zimmer

L. O.

Goldstein

L. B.

Alberts

M. J.

Fagan

S. C.

Fonarow

G. C.

Johnston

S. C.

Kidwell

Labresh

K. A.

Ovbiagele

Schwamm

Peterson

E. D.

AVAIL Investigators (2011). Secondary preventive medication persistence and adherence 1 year after stroke. Neurology, 77(12), 1182–1190. https://doi.org/10.1212/WNL.0b013e31822f0423

Dalkin

S. M.

Hardwick

Haighton

C. A.

Finch

T. L.

(2021). Combining realist approaches and normalization process theory to understand implementation: A systematic review. Implementation Science Communications, 2(1), 68. https://doi.org/10.1186/s43058-021-00172-3

Das

Ghosh

Khanna

Banerjee

Mondal

G. P.

Singh

O. P.

Chakraborty

(2010). Discontinuation of secondary preventive treatment of stroke: an unexplored scenario in India. Clinical Neurology and Neurosurgery, 112(9), 766–769. https://doi.org/10.1016/j.clineuro.2010.06.007

Edwards

J. D.

Kapral

M. K.

Fang

Swartz

R. H.

(2017). Long-term morbidity and mortality in patients without early complications after stroke or transient ischemic attack. CMAJ : Canadian Medical Association journal = journal de l'Association medicale canadienne, 189(29), E954–E961. https://doi.org/10.1503/cmaj.161142

Fisher

R. J.

Chouliara

Byrne

Cameron

Lewis

Langhorne

Robinson

Waring

Geue

Paley

Rudd

Walker

M. F.

(2021). Large-scale implementation of stroke early supported discharge: The WISE realist mixed-methods study. NIHR Journals Library.

Gaglio

Phillips

S. M.

Heurtin-Roberts

Sanchez

M. A.

Glasgow

R. E.

(2014). How pragmatic is it? Lessons learned using PRECIS and RE-AIM for determining pragmatic characteristics of research. Implementation Science: IS, 9(1), 96. https://doi.org/10.1186/s13012-014-0096-x

10.

GBD 2019 Stroke Collaborators (2021). Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. The Lancet. Neurology, 20(10), 795–820. https://doi.org/10.1016/S1474-4422(21)00252-0

11.

Glasgow

R. E.

Harden

S. M.

Gaglio

Rabin

Smith

M. L.

Porter

G. C.

Ory

M. G.

Estabrooks

P. A.

(2019). RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Frontiers in Public Health, 7( 1 ), 64. https://doi.org/10.3389/fpubh.2019.00064

12.

Kate

M. P.

Arora

Verma

S. J.

Sylaja

P. N.

Renjith

Sharma

Pandian

J. D.

SPRINT India Collaborators (2020a). Secondary Prevention by Structured Semi-Interactive Stroke Prevention Package in India (SPRINT INDIA) study protocol. International Journal of Stroke : Official Journal of the International Stroke Society, 15(1), 109–115. https://doi.org/10.1177/1747493019895653

13.

Kate

M. P.

Verma

S. J.

Arora

Sylaja

P. N.

Padma

M. V.

Bhatia

Khurana

Sharma

Ojha

P. K.

Renjith

Kulkarni

G. B.

Sadiq

Jabeen

Borah

N. C.

Ray

B. K.

Sharma

Pandian

J. D.

(2020b). Systematic Development of Structured Semi-interactive Stroke Prevention Package for Secondary Stroke Prevention. Annals of Indian Academy of Neurology, 23(5), 681–686. https://doi.org/10.4103/aian.AIAN_639_19

14.

Khanevski

A. N.

Bjerkreim

A. T.

Novotny

Naess

Thomassen

Logallo

Kvistad

C. E.

NOR-STROKE study group (2019). Recurrent ischemic stroke: Incidence, predictors, and impact on mortality. Acta Neurologica Scandinavica, 140(1), 3–8. https://doi.org/10.1111/ane.13093

15.

Lindsay

M. P.

Norrving

Sacco

R. L.

Brainin

Hacke

Martins

Pandian

Feigin

(2019). World stroke organization (WSO): Global stroke fact sheet 2019. International Journal of Stroke: Official Journal of the International Stroke Society, 14(8), 806–817. https://doi.org/10.1177/1747493019881353

16.

Moore

G. F.

Audrey

Barker

Bond

Bonell

Hardeman

Moore

O'Cathain

Tinati

Wight

Baird

(2015). Process evaluation of complex interventions: Medical Research Council guidance. BMJ (Clinical Research ed.), 350(1), h1258. https://doi.org/10.1136/bmj.h1258

17.

O’Cathain

Murphy

Nicholl

(2010). Three techniques for integrating data in mixed methods studies. BMJ (Clinical Research ed.), 341(1), c4587. https://doi.org/10.1136/bmj.c4587

18.

Pandian

J. D.

Gall

S. L.

Kate

M. P.

Silva

G. S.

Akinyemi

R. O.

Ovbiagele

B. I.

Lavados

P. M.

Gandhi

Thrift

A. G.

(2018). Prevention of stroke: A global perspective. Lancet (London, England), 392(10154), 1269–1278. https://doi.org/10.1016/S0140-6736(18)31269-8

19.

Pandian

J. D.

Verma

S. J.

Arora

Sharma

Dhaliwal

Khatter

Huilgol

Sylaja

P. N.

Dhasan

Renjith

Pathak

Pai

Sharma

Vaishnav

Ray

Khurana

Mittal

Kulkarni

Sebastian

Reddy

Y. M.

(2021). INSTRuCT: Protocol, Infrastructure, and Governance. Stroke, 52(10), e574–e580. https://doi.org/10.1161/STROKEAHA.120.033149

20.

Patton

M. Q.

(1999). Enhancing the quality and credibility of qualitative analysis. Health Services Research, 34(5 Pt 2), 1189–1208.

21.

Perreault

A. Y.

Côté

Dragomir

White-Guay

Dumas

(2012). Adherence to antihypertensive agents after ischemic stroke and risk of cardiovascular outcomes. Neurology, 79(20), 2037–2043. https://doi.org/10.1212/WNL.0b013e3182749e56

22.

Quintans

J. R.

Yonekura

Trapé

C. A.

Soares

C. B.

(2020). Realist evaluation for programs and services in the health area: an integrative review of the theoretical and methodological literature. Revista latino-americana de enfermagem, 28(1), Article e3255. https://doi.org/10.1590/1518-8345.3933.3255

23.

Ray

B. K.

Hazra

Ghosal

Banerjee

Chaudhuri

Singh

Das

S. K.

(2013). Early and delayed fatality of stroke in Kolkata, India: results from a 7-year longitudinal population-based study. Journal of Stroke and Cerebrovascular Diseases : The Official Journal of National Stroke Association, 22(4), 281–289. https://doi.org/10.1016/j.jstrokecerebrovasdis.2011.09.002

24.

Skivington

Matthews

Simpson

S. A.

Craig

Baird

Blazeby

J. M.

Boyd

K. A.

Craig

French

D. P.

McIntosh

Petticrew

Rycroft-Malone

White

Moore

(2021). Framework for the development and evaluation of complex interventions: gap analysis, workshop and consultation-informed update. Health Technology Assessment (Winchester, England), 25(57), 1–132. https://doi.org/10.3310/hta25570

25.

Srinivasapura Venkateshmurthy

Mc Namara

Koorts

Mohan

Ajay

Jindal

Malipeddi

B. R.

Roy

Tandon

Prabhakaran

Worsley

Maddison

O'Reilly

(2019). Process evaluation protocol for a cluster randomised trial of a complex, nurse-led intervention to improve hypertension management in India. BMJ Open, 9(5), Article e027841. https://doi.org/10.1136/bmjopen-2018-027841

26.

Statista . (2021a). Internet penetration rate in India from 2007 to 2021. https://www.statista.com/statistics/792074/india-internet-penetration-rate/Retrieved

27.

Statista . (2021b). Number of smartphone users in India in 2015 to 2020 with a forecast until 2025. https://www.statista.com/statistics/467163/forecast-of-smartphone-users-in-india/Retrieved

28.

Sureshkumar

Murthy

Natarajan

Naveen

Goenka

Kuper

(2016). Evaluation of the feasibility and acceptability of the 'Care for Stroke' intervention in India, a smartphone-enabled, carer-supported, educational intervention for management of disability following stroke. BMJ Open, 6(2), Article e009243. https://doi.org/10.1136/bmjopen-2015-009243

29.

Sylaja

P. N.

Pandian

J. D.

Kaul

Srivastava

Khurana

Schwamm

L. H.

Kesav

Arora

Pannu

Thankachan

T. K.

Singhal

A. B.

(2018). Ischemic Stroke Profile, Risk Factors, and Outcomes in India: The Indo-US Collaborative Stroke Project. Stroke, 49(1), 219–222. https://doi.org/10.1161/STROKEAHA.117.018700

30.

Yeo

K. K.

Zheng

Chow

K. Y.

Ahmad

Chan

Chang

H. M.

Chong

Chua

Foo

Low

L. P.

Ong

H. Y.

Koh

T. H.

Tan

H. C.

Tang

K. F.

Venketasubramanian

(2017). Comparative analysis of recurrent events after presentation with an index myocardial infarction or ischaemic stroke. European Heart Journal. Quality of Care & Clinical Outcomes, 3(3), 234–242. https://doi.org/10.1093/ehjqcco/qcw048

31.

Zhang

Creswell

(2013). The use of “mixing” procedure of mixed methods in health services research. Medical Care, 51(8), e51–e57. https://doi.org/10.1097/MLR.0b013e31824642fd

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