Adaptation Outcomes of a CAPABLE-Family Open-Label Pilot Study for Community-Dwelling Older Adults With Mild Cognitive Impairment/Early Dementia and Disability

Abstract

Background

Despite the high prevalence of physical disabilities among older adults with cognitive impairment, physical function is rarely addressed.

Objective

This study evaluates acceptability and feasibility of CAPABLE-Family, a home-based intervention adapted from CAPABLE to support older adults with mild cognitive impairment (MCI)/early dementia.

Methods

Thirteen participants (six older adults with care partners (dyads) and one older adult without a care partner) received the intervention and provided feedback on necessary adaptations.

Results

Participants were 86 ± 4.7 years old, 71% female, and 43% White. All but one (lost to follow-up due to medical decline) remained in the study, demonstrating feasibility. At endpoint, 100% of those completing the satisfaction survey found the program useful and would apply strategies to future goals. Key adaptations included an optional fifth RN visit, a care partner resources folder, and a care partner conversation to ensure the intervention remained focused on the older adult with MCI/early dementia.

Keywords

activities of daily living (ADLs)community dementia depression pain management

What This Paper Adds

• Determines the needs of this population early to subsequently intervene in the community.

• Provides a varied sample of dyads to understand the experience of physical disability and co-occurring memory impairment.

• Gives a unique voice to a population often stigmatized for cognitive difficulty.

Applications of Study Findings

• Application to practice: Provide caregiver specific training and education.

• Application to policy: Reduce Medicare expenditures for persons with physical disabilities and MCI/early dementia.

• Application to research: Inform and develop health interventions reflecting participants’ needs with visual research methodology.

Introduction

Older adults often face co-existing cognitive and functional decline, affecting both ADLs (self-care tasks) and IADLs (complex tasks requiring executive functioning). Environmental challenges can emerge as cognitive and functional abilities decline and can contribute to disability trajectories leading to frequent hospitalizations, institutionalization, reduced quality of life, and high mortality rates (Cipriani et al., 2020). Over time, older adults often need help with self-care tasks like bathing and dressing, which are time-consuming and costly for both them and their care partners (Alzheimer’s Association, 2019, 2022). There is a critical need to maintain and improve the functional ability of older adults with cognitive impairment, whether they live alone or with care partners. Aging in place with co-occurring functional and cognitive impairment often requires home-modifications and building new skillsets to improve activities of daily living. This study aimed to adapt an existing effective intervention to better address the daily needs of older adults with coexisting physical disability and MCI/early dementia.

The CAPABLE (Community Aging in Place, Advancing Better Living for Elders) program, with its core components of capitalizing on home-based assessments, interdisciplinary support, tailored environmental modifications, and collaborative goal-setting, addresses many of the domains that become increasingly relevant in aging individuals, especially those with co-occurring functional and cognitive impairment. CAPABLE was originally not designed to support those with memory impairment, rather, it was developed as a structured program to support community-dwelling older adults with functional disabilities. CAPABLE provides 10 60–90-minute visits delivered by occupational therapists (OTs) and registered nurses (RNs) over a 4–5-month period to improve self-identified limitations, and a handy worker for home modifications (Szanton et al., 2014). Multiple studies of the CAPABLE program have demonstrated improvements in depressive symptoms, ADLs, and IADLs compared to randomized and matched control comparison groups (Szanton et al., 2021). In one prior study, CAPABLE modified its inclusion criteria at the funders’ request and served 12 participants with dementia (MMSE score <23). Over half of these participants improved ADLs and IADLs. This suggests the need to investigate providing CAPABLE for people with early cognitive difficulties such as MCI or early dementia. This paper documents the adaptations made to CAPABLE with insights from the OTs and RNs involved in adapting CAPABLE. Using an open label pilot where all participants receive the intervention without randomization, the initial acceptability and feasibility of CAPABLE-Family was evaluated in older adults with coexisting physical disabilities and MCI/early dementia, and their care partners (Fields et al., 2022).

Methods

To adapt CAPABLE into “CAPABLE-Family,” we used several methods to garner input from multiple stakeholders (e.g., photovoice and semi-structured interviews during our open label pilot). Consistent with the updated MRC Framework for developing and evaluating complex interventions (Skivington et al., 2021), this study followed an iterative development process in which a pre-pilot photovoice phase (Jenkins et al., 2025) informed intervention refinement. The present open label pilot study, which is a pilot study where participants are not randomized and know that they are receiving the intervention, served as a feasibility assessment to evaluate acceptability and refine the necessary adaptations to CAPABLE using semi-structured interviews with clinicians.

Recruitment and Consent

Older adults with MCI/early dementia and care partners were recruited from multiple sources including flyers in churches, memory clinics, senior high-rise apartment buildings, an Electronic Health Record Recruitment Service, social media postings (Facebook, Nextdoor, Craigslist, Instagram), and studies or programs for which participants had been ineligible due to cognitive impairment. Interested individuals completed a pre-screening recruitment survey via telephone, which included cognitive assessment using the Montreal Cognitive Assessment (MoCA)-Blind as there are no visual tasks to complete (Nasreddine et al., 2005).

Eligibility

Eligible participants were community-dwelling people aged 60 or older with at least one ADL disability and cognitive impairment (defined in our study as a MoCA-Blind score between 8 and 18, with scores between 14 and 18 reflecting MCI, and 8–13 reflecting early dementia). Older adults could participate with or without an informal care partner.

Ethical Considerations

Following eligibility screening, a study team member met with the older adult and care partner, if applicable, to describe the study purpose, duration, risks, and outcomes. During this visit it was determined whether a participant was interested in participating, and a written consent form for the older adult and care partner was completed.

Capacity to provide informed consent for participants with MCI/early dementia was evaluated in accordance with the study protocol approved by our institution’s Institutional Review Board (IRB). The IRB-approved consent materials were written in a format that requires the study team to reiterate and restate key information to ensure comprehension. During the consent discussion, research staff assessed understanding through ongoing conversation check-ins, in which participants were asked to describe the study’s purpose, procedures, risks, and voluntary nature of their participation in their own words. Participants were only enrolled if they could demonstrate adequate understanding. The Johns Hopkins Institutional Review Board (IRB00243117, IRB00281553) approved this study.

Confidentiality and Data Handling

Measures were taken to protect participants’ autonomy, privacy, and well-being during home visits. All home-based interactions were conducted with sensitivity to participant comfort with CAPABLE trained, seasoned clinicians. Participants retained the right to pause or discontinue visits at any time. Study procedures involving physical, cognitive, or environmental assessments were explained prior to initiation, and participants could decline any component without consequence.

Data handling and confidentiality, such as demographics and survey responses, were stored separately from their identifying information to reduce risk of identification. All data were stored on secure, access-restricted systems consistent with IRB and institutional policies. Quantitative and qualitative datasets were de-identified prior to analysis. Identifiers were removed from transcripts and survey files. A coded linking-file was stored separately in a secure location. These procedures ensured participant privacy and protected the confidentiality of participants across all phases of data collection.

Framework

This study was guided by two theories: the Disablement Process Model and the Theory of Dyadic Illness Management. In the Disablement Process Model: (1) acute and chronic conditions (pathology) lead to impairments that affect functioning; and (2) personal/internal and environmental/external factors speed up the trajectory to disablement (Verbrugge & Jette, 1994). Improving person-environment fit slows the trajectory of disablement and addresses secondary outcomes such as pain (Szanton et al., 2014; Van Vianen, 2018). Additionally, the Theory of Dyadic Illness Management posits that if both people in a dyad appraise a situation similarly, they can manage symptoms better and experience better health (Lyons & Lee, 2018).

Therefore, to adapt the CAPABLE program for dyads in which one member is experiencing cognitive impairment, we qualitatively explored risk factors for disablement and dyadic management behaviors using human-centered design methods (Bazzano et al., 2017). Human-centered design includes (1) empathy for end-user’s needs through contextual observations of users in their environment; (2) synthesis and ideation or collaboration with tested constraints and stakeholder brainstorming; and (3) iterative user-driven prototyping or testing of simpler faster versions of the ultimate program (Roberts et al., 2016). Although the original focus of the research was on dyads, we included one participant without a care partner to reflect the 8% of adults who do not receive help from a family member or other informal care provider (Alzheimer’s Association, 2022).

Figure 1 outlines the design and timeline of the study. As a brief overview, 121 individuals were screened, 26 were not interested, and 55 were ineligible or excluded for reasons such as having no ADL impairment or being fully independent, not meeting MCI/early dementia criteria, not responding to outreach, or not being community dwelling. Additional individuals were not enrolled due to loss to follow-up, declining participation for unclear reasons, or being asked to be contacted later for an upcoming randomized trial phase. Fifteen individuals were eligible at screening and enrolled into this open-label pilot study; two enrolled participants were lost to follow-up prior to intervention start, and thirteen were subsequently allocated to the intervention. All 13 allocated participants completed the intervention.

Figure 1.

CAPABLE-Family pilot consort diagram

The CAPABLE-Family intervention was tailored to the physical and cognitive capacity of the participants. Consistent with the original CAPABLE program, the adapted intervention consisted of three main components delivered by an OT, RN, and Handy worker (HW). The original CAPABLE study process and intervention content by visit are described in detail elsewhere (Szanton et al., 2014). Briefly, CAPABLE participants receive approximately ten 1-hour sessions with an OT and an RN and an average of two visits from the HW to provide repairs/modifications with a budget of $1,300 per household, over a 4–5-month period (Szanton et al., 2021).

Based on feedback from participants in the pre-pilot photovoice phase, we increased the intervention time, with CAPABLE-Family participants receiving six 45–150-minute OT sessions over 4 to 6 months and four-to-five 60–135-minute RN sessions over 6 months. OT sessions were guided by a function-focused assessment, which helped older adults select actionable goals that were important to them. Visit content included fall prevention and recovery education, a home safety assessment to identify modifications/repairs and determine supplies needed related to their goals, and training on new assistive devices and home modifications. Interventionists clinically tailored intervention-related content to the dyad’s risk profile and goals. An example would be the OT brainstorming and developing an action plan with the person living with MCI/early dementia, or the dyad, related to organizing their mail/papers and clothing to decrease clutter in the older adult’s home.

The RN sessions occurred between the OT sessions over the same 4–6-month timeframe. After assessment, the RN helped the older adult with MCI/early dementia develop goals that mattered to them. For example, a participant-driven goal from the open label pilot phase was to reduce pain to be able to vacuum and wash clothes independently. To accomplish this, the participant chose to do CAPABLE exercises (e.g., seated leg lifts), taking Tylenol, and, for stress relief, incorporating daily prayer/meditation with church service recordings.

The HW component was contracted with Civic Works, a community-based non-profit that trains young AmeriCorps volunteers in construction skills. Civic Works coordinated the repairs and modifications and ordered the assistive devices and supplies for each participant. The HW made on average 2 visits to the homes to provide the repairs/modifications. The budget was $1,300 per household. There were no adaptations from the original CAPABLE to the HW sessions for this open label pilot study.

Both the OT and RN sessions included a readiness to change assessment gathered on their first and last visits, respectively (range: 1: precontemplation to 4: action; Prochaska & Norcross, 2001).

Measures

Evaluators gathered assessment data at baseline and at a 6-month follow-up visit via an in-person or telephone interview with study staff. Data was uploaded to REDCap, an online software that manages data entry with built-in safety features to minimize data entry errors such as range checks, branching logic, and calculated fields. The measures included the Activities of Daily Living (Katz), the Instrumental Activities of Daily Living (Lawton-Brody; Lawton & Brody, 1969), The Patient Health Questionnaire (PHQ-8; Kroenke et al., 2009), the PROMIS - Pain Interference - Short Form 8A questionnaire (Teresi et al., 2016), and the Perceived Change in Function Scale.

Goal Development and Completion Outcomes

The OT and RN conducted their initial visits using semi-structured rapport building with the Client-Clinician Assessment Protocol (C-CAP OT or C-CAP RN) and clinical observations. The OT focused assessments on the participants’ self-perceived level of functional mobility, ADLs, and IADLs and readiness to change. The RN assessed medication and pain management, typical daily activities, diet, oral health practices, depressive symptoms, psychosocial and social support, wellbeing, evidence of abuse, strength and balance, fall assessment and risk, diabetes support, vision and hearing status, clinician communication strategies, as well as their readiness to change. Each clinician collaborated with participants to identify and prioritize up to three treatment goals. Goals were rated by the participants at the end of the intervention as “fully met,” “partially met,” or “not met.”

Acceptability and Feasibility Outcomes

We measured study acceptability by examining percentages of people who stayed in the study as well as goal achievement. Satisfaction with the CAPABLE-Family intervention was assessed by participants with qualitative surveys at the midpoint and end of the open label pilot. Feasibility outcomes were assessed with OTs’ and RNs’ qualitative responses to predetermined questions related to their experiences. 15 RNs and OTs were interviewed using a semi-structured interview guide to capture clinicians’ experiences.

Sample Size and Analysis

We recruited fifteen participants (seven older adults with MCI/early dementia with care partners and one older adult without a care partner). Due to resource constraints, we could not address a pest infestation that existed in the home of one dyad; hence, they were not able to participate in the study. One of our feasibility outcomes was to look at recruitment and retention in our open label pilot sample for a future trial though we did not have statistical power to detect significant differences in pre- and post-assessments.

Analytic Approach

We used descriptive statistics such as means and percentages to analyze the sample’s demographic characteristics. Mixed method data, both quantitative descriptive and qualitative survey data, were used to determine feasibility and acceptability. Program satisfaction was evaluated at 6 months among the participants in the form of a qualitative survey, and we conducted qualitative analyses of clinician interview data.

Qualitative data were analyzed using thematic analysis (Castleberry & Nolen, 2018). Semi-structured interview transcripts were analyzed to understand clinician and participant experiences relevant to adaptation of the CAPABLE-Family intervention. Transcripts were independently coded by two coders: the primary author (EJ) and a secondary member of the study team who was not directly involved in the open-label pilot.

Words and phrases were tagged and indexed electronically using F4Analyse qualitative data analysis software (f4analyse, 2020). Through an iterative analytic process, codes were compared across transcripts and grouped into categories that were progressively refined into broader themes through ongoing team discussion. Coding discrepancies were discussed among investigators until consensus was achieved.

To enhance analytic rigor and credibility, themes identified through transcript coding were compared with themes emerging from a collaborative Mural board that was developed concurrently by the research team during analytic meetings. This comparison supported triangulation across analytic approaches and helped ensure consistency between individual coding and team-based thematic interpretation.

The research team engaged in regular discussions to reflect on interpretations and potential assumptions during coding and theme development. Credibility was further supported through independent coding, consensus-based resolution of discrepancies, and use of multiple analytic artefacts.

In addition to qualitative analysis, feasibility outcomes were examined, including recruitment, retention, and study completion rates for a future trial. Time feasibility was assessed by examining length of visits and overall duration of program completion.

Results

Demographics (Six Dyads and One Older Adult Without a Care Partner (n = 13))

Participants with MCI/early dementia (n = 7) were 86 years old on average (SD = 4.70), 71% female, 43% White, and 57% had a master’s degree. Of the five participants who provided income data, 50% had a family income of ≥ $75,000. Approximately 28% of the sample were men (Table 1). In terms of cognition, 57% had scores indicative of an MCI stage of cognitive impairment (MoCA Blind 14–18) and 43% had scores indicative of a mild/early dementia stage of impairment (MoCA Blind 8–15 (out of 22 points)). Of the care partners (n = 6), 50% were between 50 and 69 and 50% were 80 and 89. All care partners cared only for one individual, the older adult with comorbid MCI/early dementia and physical disability, and 50% had one or more jobs/volunteer work each week with hours ranging from <10 to 40 hours/week. 50% of dyads had spousal care partners, and the other 50% were a child or in-law. Additionally, 67% of care partners documented at least 6 hours of care per week.

Table 1.

Participants’ Characteristics at Study Baseline, CAPABLE-Family, N = 13

Characteristics	Older adult (n = 7)	Care partner (n = 6)
Age at study baseline, years (or range) (M+/- SD)	86 +/- 4.70	50–89
Education
8^th grade/less to some college	3 (43%)	2 (33%)
Associate to professional degree	4 (57%)	4 (67%)
Race
White	3 (43%)	3 (50%)
Black	2 (28.5%)	2 (33%)
Asian	2 (28.5%)	1 (17%)
Sex
Male	2 (28.5%)	2 (33%)
Female	5 (71.5%)	4 (67%)
Cognition (MoCA blind, 0–22)
Mild cognitive impairment (MoCA blind 14–18)	4 (57%)	-
Mild/early dementia (MoCA blind 8–15)	3 (43%)	-
Family income	(Missing 2)
US$25–$34,999	1 (14%)	1 (17%)
US$35–$49,999	1 (14%)	-
US$50–$74,999	-∼ (29.5%)	1 (17%)
US$75–$99,999	2 (28.5%)	2 (33%)
US$100,000 and over	1 (14%)	2 (33%)
Residential type
Single family home	4 (57%)	-
Apartment	2 (29%)	-
Condo or townhome	1 (14%)	-
Relationship of participants
Spouse	3 (43%)	-
Child/other relative	3 (43%)	-
No care partner participating	1 (14%)	-
Cares for another person	-	3 (50%)
Works
<10 hours/week	-	1 (17%)
40 hours/week	-	2 (33%)
Older adult ADLs (M+/- SD)	4 +/- 2.62	5.3 +/- 2.13
Older adult IADLs	3.71 +/- 1.83	5.7 +/- 2.36
Pain interference	10.1 +/- 2.47	11 +/- 4.6
Depression symptoms	2.71 +/- 1.91	4.3 +/- 3.09

Care Partner Sentiment and Involvement

At baseline, 83% of care partners felt at least somewhat satisfied with their present caregiving arrangement. At the midpoint of the intervention (∼3 months into the study), approximately 67% of the care partners documented CAPABLE-Family involvement in enrollment, scheduling, and being present for at least 1 OT session and 1 RN Session. This percentage describes the degree of care partner participation in elements of the CAPABLE-Family pilot. At the end of the intervention, care partners participated in 50% of all research study visits.

Research Study Duration and Visit Length

Participants had six OT visits (average length 84.88 minutes) and four RN visits (average length 96.52 minutes). For RN and OT sessions, longer visits occurred more for persons with MCI than in those with early dementia.

Goals

Table 2 outlines the goals set during the RN and OT visits for participants in the CAPABLE-Family program. Each goal is marked as either fully met (white square) or partially met (gray square), providing a visual representation of the progress made in various domains. The RN visit goals primarily focused on medication management, fall prevention, social support, and pain management. OT visit goals emphasized mobility, ADLs, IADLs, and social support. The goals were tailored to address specific needs of the participants, highlighting the comprehensive and personalized approach of the CAPABLE program in enhancing the quality of life for older adults. By the endpoint, 100% of participants’ goals set during the study were at least partially met; while 72% of the goals the participant chose with the RN and 78% of the goals the participants chose with the OT were fully met. The majority of goals the participants chose with the RNs which were fully met were classified as “other,” meaning the participant goal was self-identified and did not arise from a list of options.

Table 2.

RN and OT Visit Goals From the Open Label Pilot Rubric

ID	RN visit goals			OT visit goals
ID	Goal 1	Goal 2	Goal 3	Goal 1	Goal 2	Goal 3
1001	Other: Will maintaining driving privileges or find alternatives if license is revoked	Fall prevention: Will use assistive devices when ambulating around the house and outside the house	Other: Will organize or find storage for depends	IADL: Take medications on time	Mobility: Walk about the distance of the block (grocery store)	ADL: Get better rest and sleep
1002	Social support and isolation: Food delivery service for meals and company (meals on wheels) with flavored prune juice for constipation	Social support and isolation: Calling friends despite challenges with hearing aid	Fall prevention: Doing laundry by myself	Mobility: To be able to get in/out of tub safely (CP wants her to do her hygiene properly)	Mobility: To be able to get in/out of the rear porch door safely	Other: To organize mail/paper and clothing (CP goal)
1003	Mood: To not have anxiety 1–2 nights weekly due to staying awake thinking about health and unresolved issues and to have a peaceful rest	Fall prevention: To be the steadiest using new pushcart with wheels during grocery shopping	Medications: To read the fine print on prescription bottles	Mobility: Walk outside 30–45 minutes 6x/week	Mobility: Kneel down to reach items and pick them up easier	IADL: Organize work time and activity schedule
1004	Medications: Take meloxicam as schedule does not adhere to taking it daily only when needed	Pain: Resume chair yoga at the YMCA virtually 2x per week	Other: Sleep schedule. Get to bed by 12:30 am on Friday to attend Bible study Saturday morning at 8:30 am. Make my bed daily	ADL: Cook without taking so many breaks	ADL: Toileting—make wiping easier	Mobility: Ability to reach something easier
1005	Medications: Assist care partner with filling med box	Other: Complete daily seated exercise	Incontinence: Complete Kegels 4x daily	IADL: To be able to text family in case of change in plans	Mobility: To get in/out of cars easier	IADL: Keep track of glasses
1007	Pain: Reduce pain to vacuum and wash clothes	Incontinence: Reduce cost of underwear	Social support and isolation: Travel/social support —van service to get to church	Mobility: Tub and toilet transfers	ADL: Getting socks on	Mobility: Bending/reaching down to get an item
1008	Pain: Originally medications—getting pill box and medications in order; changed to try to get this pain in control	Fall prevention: Getting out of the house to go for a walk	Social support and isolation: Get to church to hand out food to persons in need	Mobility: Cell phone use	IADL: Lifting/bending to put up heavy items; changed to carrying items on the steps	IADL: Keeping track of appointments

Goals fully met = white square; goals partially met = gray square.

38% percent of RN visit goals were related to fall prevention and social support, and included maintaining driving privileges, using assistive devices for ambulation, organizing storage for incontinence products, reading prescription labels, taking medications on schedule, resuming chair yoga, reducing anxiety, improving sleep quality, and reducing pain to perform household chores. 81% percent of OT visit goals focused on mobility and IADLs, specifically on walking longer distances, safely transferring in and out of bathtubs and/or cars, cooking without frequent breaks, toileting, getting dressed independently, organizing work schedules, texting family members, traveling to social events, and participating in community activities.

Adaptation Outcomes

Qualitative feedback from the RNs and OTs who implemented the CAPABLE-Family intervention in this open label pilot study is organized in Table 3 and is categorized based on specific questions related to the sessions and outlines the resulting adaptations implemented in the CAPABLE-Family program.

Table 3.

Qualitative Feedback From RNs and OTs From the Open Label Pilot

Open label pilot feedback question	RN feedback/sample quote	OT feedback/sample quote	Resultant change for CAPABLE-Family
How was this session different from your experience seeing a client without memory issues?	“Client is easily distracted by environment, i.e., people coming in and out of the house, conversations can have tangents.”	“Needs more time due to her hearing deficits, us wearing masks, and her STM issues.”	Adding an optional 5^th RN visit—addresses the additional time needed due to memory changes and sensory deficits of clients
Did you feel equipped on how to handle the differences? What other guidance/structure should we provide for clinicians who might be less familiar with MCI/early-stage dementia?	“Suggestion on teaching how to communicate with those farther along in dementia, i.e., shorter sentences, giving 1-2 choices, asking concrete questions.”	“Yes, include the CP but don’t let them overshadow what the client really wants if it is a safe option.”	Adding a care partner resource folder/clinician care partner training—addresses the need for training/education for care partners and clinicians necessary for improved function in persons with MCI/early dementia
If applicable, to what extent did the care partner participate? Were there issues with not enough or too much participation?	“Care partner participated appropriately, let client answer questions first before speaking, gave client ample time to think about answers.”	“CP shared that he gets anxious before appointments. I Asked him to describe that feeling and why it happens. We discussed and he wanted to have the dates of all visitors coming to their home on the calendar because he says he confuses them.”	Informal care partner involvement/older adult focus of the conversation—addresses the importance of appropriate communication with care partners and older adults which centers the older adult as the focus of the visit
Were there any issues that came up for you or do you have any suggestions related to: introducing the session goal/connecting this visit to last visit, reviewing strategies and action plans, assessing goal achievement, or closure of intervention, other?	“Length between visits might be too long for someone with memory issues. Client didn’t remember talking about goals from last visit/priorities changed.”	“Brainstorming took longer and more detailed for the goal of being better organized when cooking/baking.”	Additional relevant form—action plan for brain health—addresses concerns about memory issues/brain health and the difficulty with brainstorming for persons with cognition difficulties
Were there any issues that came up for you or do you have any suggestions related to: brainstorming/problem-solving process, action planning, environmental assessment/equipment needs, and time management?	“Care partner was unable to participate due to his health concerns. An exercise link should be provided with activity booklet due to some participants [which are] tech savvy.”	“Many changes since my last visit due to client having a spontaneous lower back fracture. This led to a hospital stay, rehab, now home with HHJPT and RN. Also, the CAPABLE RN started at the same time. Overwhelmed as their children are making them move to a 1-level apartment situation and leaving their home of many years and memories tried to support this new situation as best as possible. Addressed immediate needs of more energy efficient bed transfers. Helped him identify a new goal to replace his final goal of lifting items easier as he is now not allowed to do any lifting.”	Additional relevant form—action plan for social support—addresses social needs such as care partner support during an illness or dealing with a move, hospital stay, etc.

With relation to the adaptation of increasing intervention time, with CAPABLE-Family participants receiving six 45–150-minute OT sessions over 4 to 6 months and four-to-five 60–135-minute RN sessions over 6 months, RNs reported, “[The] client is easily distracted by environment, i.e., people coming in and out of the house, conversations can have tangents.” While OTs noted the need for more time due to non-modifiable participant factors, as described in the quote, “Needs more time due to her hearing deficits, us wearing masks, and her STM [short-term memory] issues.” To address these challenges, the program added an optional fifth RN visit to accommodate the additional time needed due to memory changes and sensory deficits.

Additionally, the RNs suggested teaching clinicians effective communication strategies, highlighted by the quote, “Suggestion on teaching how to communicate with those farther along in dementia, i.e., shorter sentences, giving 1-2 choices, asking concrete questions.” Prompting changes such as using shorter sentences and concrete questions as an adaptation in CAPABLE-Family. OTs emphasized the importance of including the care partner “but [not letting] them overshadow what the client really wants,” reinforcing a focus on centering goals around the older adult while still including the care partner. This feedback led to the introduction of a Care Partner Resource folder and clinician Care Partner training to provide necessary education for improved function in participants with MCI/early dementia.

Further feedback (Table 3) indicated that care partners generally participated appropriately, allowing clients to answer questions first and giving them ample time to think about their responses. In situations when the care partner did not allow the older adult time to contemplate, CAPABLE clinicians re-focused the conversations on the older adult. RNs reported that the length between visits might be too long for clients with memory issues, as clients often did not remember discussing goals from previous visits. OTs found that brainstorming took longer and required more detailed strategies for goals such as being better organized when cooking or baking. To address these concerns, the program introduced an additional relevant form for action plans focused on brain health. OTs described significant changes in clients’ situations, such as spontaneous health issues leading to hospital stays and rehabilitation, which required immediate support and adjustments to goals. The program responded by adding an action plan for social support, addressing the social needs of clients and care partners during illnesses, moves, hospital stays, and other significant life changes.

In summary, we adapted the CAPABLE intervention to include an optional fifth RN visit, adding a Care Partner Resource Folder/Clinician Care Partner Training (including relevant information for memory challenges, e.g., the Alzheimer’s Associations 24/7 Helpline), centering conversations with care partners on the older adult with MCI/early dementias’ goals, tailoring clinician communication strategies for MCI/early dementia, and including documents which reflect information about brain health and social support. Together, these insights directly guided refinements to make CAPABLE-Family more responsive, supportive, and tailored for participants with memory changes and their care partners. No adaptations were made related to the handy worker portion of the original CAPABLE program.

Feasibility and Acceptability Outcomes

We administered open-ended surveys at the midpoint and end of the study to assess feasibility/acceptability. From the midpoint qualitative survey, 71% of participants were satisfied with the length of all visits. For the RN visits, 57% of participants were satisfied with the length of the visits, and 71% stated visit content was easy to understand. For the OT visits, 71% of participants were satisfied with the length of the visits at midpoint and 57% stated visit content was easy to understand. From the endpoint qualitative survey, ≥57% of participants were content with their OT goal creation, goal achievement, and visit length, and 43% of participants were content with their goal creation with RNs and visit length. Ultimately, 87% of the participants were retained, with one survey incomplete due to a participant’s medical decline (Table 4).

Table 4.

Feasibility and Acceptability Outcomes from the Open Label Pilot

Domain	Metric	Operational definition	Result	Notes/interpretation
Recruitment	Individuals screened	Total number screened	121	--
	Not interested	Declined further participation	26	--
	Ineligible/excluded	Did not meet eligibility criteria (e.g., no ADL impairment, fully independent, not MCI/early dementia, non-response, and not community-dwelling)	55	Most exclusions due to functional independence or cognitive criteria^a
	Eligible and enrolled	Number eligible at screening who enrolled	15	--
	Allocated to intervention	Enrolled participants who received the intervention	13	Two lost to follow-up pre-allocation
Retention	Completed intervention	Number completing intervention ÷ allocated	13/13 (100%)	Strong feasibility despite memory impairment
Retention	Overall retention	Participants completing study participation	87%	One survey incomplete due to medical decline
Care partner involvement	Midpoint engagement	Participation in scheduling more than one OT or RN visit	67%	Reflects active mid-study partner involvement
Care partner involvement	Post-intervention engagement	Participation across total study visits	50%	Expected decline due to study burden
Adherence/fidelity	OT visits	Number completed and average duration	6 visits; 84.88 minutes	Longer visits were more common for MCI than early dementia stages
Adherence/fidelity	RN visits	Number completed and average duration	4 visits; 96.52 minutes	RN visits among MCI stage were longest
Goal setting & outcomes	OT goal completion	Percent of goals that were fully met	78% fully met; 100% at least partially met	OT goals were primarily mobility and IADL related (walking, endurance, bathing, transfers, cooking, endurance)
Goal setting & outcomes	RN goal completion	Percent of goals that were fully met	72% fully met; 100% at least partially met	A majority of fully met goals were participant-identified (“other”), 38% fall prevention and social support (anxiety/sleep goals, pain reduction, medication management)
Midpoint acceptability (participant survey)	Satisfaction with visit length (all visits)	Participants reporting satisfaction	71% satisfied	--
	RN visit length satisfaction	Satisfied with RN visit duration	57%	--
	RN visit content clarity	RN visit content was easy to understand	71%	--
	OT visit length satisfaction	Satisfied with OT visit duration	71%	--
	OT visit content clarity	OT visit content was easy to understand	57%	Some participants desired more structured materials
Endpoint acceptability	Satisfaction with RN goal creation and visit length	Participants reporting contentment	43%	Lower satisfaction may relate to complexity of RN goals
	Ability to generalize strategies	Reported “yes” to generalizing strategies to future goals	100%	Indicates strong perceived usefulness
	Would recommend the program	Reported “yes” to would you recommend this program to others	100%	High acceptability

^aSee more details related to ineligibility/exclusion reasons in Figure 1.

When assessing participant satisfaction at the endpoint, 100% of those who completed the survey stated “yes” they would be able to generalize strategies for other goals, would recommend this study to others, and stated the program was useful.

Discussion

In this open-label pilot study, we adapted CAPABLE to include older adults with MCI and early dementia. To further contextualize the contribution of this open label pilot study within the continuum of intervention development, CAPABLE-Family can be situated within the updated Medical Research Council (MRC) framework for developing and evaluating complex interventions (Skivington et al., 2021). Consistent with the MRC’s emphasis on iterative, theory-informed development, our adaptation process unfolded across two distinct but complementary phases. The pre-pilot photovoice study functioned as part of the development phase, generating in-depth insights into the lived experiences, environmental barriers, and priorities of dementia-affected dyads (Jenkins et al., 2025). These findings informed refinement of the intervention’s content, highlighted contextual determinants relevant to implementation, and supported identification of potential mechanisms of change. The present open-label pilot study, in turn, reflects the feasibility phase of the MRC framework, in which acceptability and implementation considerations are systematically examined before undertaking more rigorous evaluation. Adaptations informed by this open-label pilot study and situated within the theoretical frameworks that guided this study are presented below. By clarifying the roles of these stages within an established framework, and describing the adaptations within the theoretical frameworks, the contributions of the current study become more explicit. Our findings provide preliminary evidence that CAPABLE-Family is acceptable to deliver to dyads and feasible to deliver in a home-based format, while also identifying areas requiring optimization prior to further testing. Our findings can further be understood through the lens of the Disablement Process Model, which conceptualizes disability as the dynamic gap between an individual’s capabilities and the demands of their environment (Verbrugge & Jette, 1994) and the Theory of Dyadic Illness Management which provides a complementary framework for interpreting the relational processes we observed in this open-label pilot study (Lyons & Lee, 2018).

In the Disablement Process Model, functional decline emerges not only from underlying pathology but also from modifiable personal and environmental factors that can accelerate or slow disablement trajectories. The CAPABLE-Family adaptations specifically target these modifiable components; while ensuring they are tailored to those with co-occurring memory impairment. For example, the dementia-friendly communication education for CAPABLE-Family clinicians and care partner resource folders are consistent with the model’s emphasis on addressing risk factors including psychosocial attributes, coping resources, and health behaviors to slow functional decline and prevent exacerbators of disability. Likewise, the handyman repairs and home modifications directly reduce environmental demands, thereby narrowing the person–environment gap identified as central to the disablement process.

The Theory of Dyadic Illness Management emphasizes that illness management occurs at the level of the dyad rather than the individual, with dyadic appraisal (shared understanding of illness and needs) and dyadic management (collaborative engagement in care behaviors) serving as central mechanisms. The CAPABLE-Family clinicians observed care partners and older adults frequently negotiating goals, calibrating levels of involvement, and balancing autonomy with support, processes that correspond directly to dyadic appraisal and collaborative coping described by Lyons and Lee (2018). For instance, situations where dyads worked together to refine goals or coordinate task sharing reflect the theory’s spectrum of dyadic management behaviors, ranging from complementary to collaborative forms of engagement.

Our qualitative findings illustrate how these adaptations to the original CAPABLE may operate in practice for those with co-occurring memory impairment. Participants described improved confidence navigating daily tasks and achieving individualized goals when environmental barriers were reduced, and clinicians introduced personalized, dementia-friendly strategies. Such experiences are consistent with the Disablement Process Model’s prediction that environmental supports and intervention-driven accommodations can attenuate the progression from impairment to functional limitation, thereby supporting continued engagement in meaningful activities. Observations related to clinician communication education, the care partner resource folders, and centering on goals the older adult with MCI/early dementia developed themselves informed the adaptations in CAPABLE-Family that intentionally support dyads in achieving shared appraisal and co-management. In this way, this open-label pilot provides preliminary indications of how CAPABLE-Family components may interrupt disablement pathways, an important consideration for future efficacy testing.

Goal Setting, Goal Attainment, Behavior Change, and Visit Length

Results from this CAPABLE adaptation underscore the diverse range of individualized goals tailored to address the specific needs of participants. While clinicians introduced broad functional domains as potential areas of exploration (such as mobility, IADLs, fall prevention, and social support), participants ultimately defined the specific goals they wished to pursue, exemplifying CAPABLE-Family’s support of patient autonomy. When participants identified priorities that fell outside the standard domains, clinicians worked to translate those goals into actionable steps aligned with the program framework without overriding the participant’s intent. Example goals include maintaining driving privileges, organizing storage, improving cell phone use, assisting with medication management, completing daily exercises, walking outside, traveling to church, and lifting heavy items. Clinicians worked with the participants in collaboration, incorporating the participant-and-family’s priorities into the plan of care to address the identified goals. The 100% full or partial successful completion rate of these goals demonstrates the effectiveness of the CAPABLE program while respecting participant autonomy, shared decision-making, and tailoring care around the individual and their care partner/families to ensure a person-centered approach.

Our findings emphasized the importance of including a care partner (when available) but ensuring they did not overshadow the older adult’s wishes and goal planning. Shared or dyadic appraisal (shared understanding of illness and needs) can enhance dyadic management behaviors (collaborative engagement in care behaviors) (Lyons & Lee, 2018) and ultimately promote better outcomes for both the person with MCI/early dementia and their care partner. We found it essential to center interventions around the older adults’ goals and needs, emphasizing their autonomy and willingness to engage. Research shows that conflicts in goal-setting priorities and expectations between individuals with dementia and their care partners can hinder progress (Jogie et al., 2021). According to the Theory of Dyadic Illness Management, moments of tension or misalignment such as care partners wanting to “step in” while older adults attempt independence are consistent with known challenges associated with appraisal incongruence (Lyons & Lee, 2018). Education on effective communication with participants who were further along the dementia continuum, by asking concrete questions or using shorter sentences, was a suggested adaptation to the standard approach of interacting with the participants, again centering the older adult with MCI/early dementia in conversation. These adaptations align with Verbrugge and Jette’s (1994) assertion that environmental modifications and activity accommodation are essential mechanisms through which individuals maintain independence despite cognitive or physical impairments.

In contrast to the fully met OT goals, all partially met goals were IADL goals, whether the person had MCI or early dementia. This contrasts with the literature, which indicates that IADLs are a core clinical distinction between early dementia and mild cognitive impairment (Hall et al., 2011). Our pilot suggests that in older adults with co-occurring physical disability and MCI/early dementia, IADLs may be impacted earlier in the disease trajectory, and this may require additional time to address during the intervention. This additional time with IADLs could be addressed with longer study duration/visits to reinforce strategies and improve participants’ goal attainment, which were only partially met. Additionally, visits with persons with dementia were shorter compared to visits with persons with MCI; older adults with MCI and their families may require more time in the visits to express their concerns/communicate. The longer duration for those with fewer cognitive impairments was likely because they were more independent and took additional time to complete tasks themselves. Consistent with our findings, persons with MCI took longer to brainstorm solutions due to waning memory functions and associated word-finding difficulties (Kalbe et al., 2005). During visits with persons with an early dementia stage of memory impairment, care partners were more involved in the goal selection and the brainstorming process, resulting in shorter visits.

Care Partner Participation, Satisfaction, and Enrollment

Care partners participated in 50% of RN and OT visits. It may be useful to develop strategies to improve care partner participation in CAPABLE-Family by explicitly laying out their role at the first visit. A Care Partner Resource Folder and relevant Clinician Care Partner Training may increase the care partner’s CAPABLE-Family participation.

Limitations include that the study was designed only to adapt CAPABLE, not to infer intervention impact. The current findings are also not generalizable to the general population, and we acknowledge that due to the small, highly motivated sample, goal-attainment ratings may have been inflated due to expectancy effects. The open-label pilot study with its by-design lack of a control group, along with the close clinical involvement of study staff, may have contributed to enhanced participant engagement, which can bias subjective outcome measures. Although these contextual factors are inherent to early-stage feasibility work, they underscore the need for larger, controlled studies with more independent assessment procedures to better determine the robustness and generalizability of these preliminary findings. Strengths of this study include that it extends CAPABLE, a program that has demonstrated consistent results in reducing ADL disability (Szanton et al., 2021). A second strength is that the intervention is tailored and replicable for older adults with MCI/early dementia. Third, given that living with dementia is costly, this intervention has the potential to reduce Medicare expenditures (Ruiz et al., 2017) while allowing older adults with MCI/early dementia and disability to thrive as healthy and functioning community members. Lastly, a strength of the study was the demographic variation of the sample by education, race, sex, cognitive status, family income, residential type, and participant relationship.

Conclusion

This CAPABLE-Family adaptation contributes to the literature by providing preliminary indications that participants with MCI or early dementia perceived improvements in daily functioning and goal attainment. This pilot study also provides initial acceptability and feasibility of CAPABLE-Family and provides insights into how the CAPABLE-Family program may preserve and enhance daily function in persons with cognitive difficulties which is a public health goal. A subsequent larger, controlled study is necessary to evaluate these findings further.

Footnotes

Acknowledgments

We would like to thank the participants for their time and contribution to this study.

ORCID iDs

Inga Antonsdottir

Qiwei Li

Valerie Cotter

Ethical Considerations

The Johns Hopkins Medical Institutions Internal Review Board approved this study (IRB00243117 and IRB00281553).

Author Contributions

EJ, SS, JT, EH, JG, JW, QS, QL, VC, CO, and MB designed the intervention, contributed to study design, and/or data acquisition. IMA and EJ drafted the manuscript and GR, AEG, GH, JSR, RSW, VC, HH, SC, and SS revised the manuscript for intellectual content. All authors read and approved of the final manuscript.

Funding Statement

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: We disclose receipt of the following financial support for the research and publication: NIH National Institute of Aging (R36AG07210-01) (3T32AG066576-03S1), the Rita and Alex Hillman Foundation (19043041), and National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR) (90RTGE0003). NIDILRR is a Center within the Administration for Community Living (ACL), Department of Health and Human Services (HHS). The contents of this publication do not necessarily represent the policy of NIDILRR, ACL, or HHS, and we do not assume endorsement by the Federal Government.

Declaration of Conflicting Interests

The authors declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: Under a license agreement between 1) National Center for Healthy Housing, 2) Muskegon Community Health Project, 3) Colorado Visiting Nurse Association, 4) Johns Hopkins Home Health Services, Inc., 5) Triad HealthCare Network, 6) Village Practice Management, LLC, 7) Iowa Department on Aging, 8) Minnesota River Area Agency on Aging, Inc., 9) Petersburg Medical Center, 10) Colorado Visiting Nurse Association, and Johns Hopkins University, which involves technology described in this presentation, the University is entitled to remunerations. Dr. Szanton is an inventor of this technology. This arrangement has been reviewed and approved by Johns Hopkins University in accordance with its conflict-of-interest policies.

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