RecruitingNot Applicable

CAPABLE Care + Connect

United States450 participantsStarted 2025-08-14

Plain-language summary

In this evaluation scale-up research project, the investigators seek to test an implementation of CAPABLE on the infrastructure of home-based primary care for individuals who may experience social isolation and/or loneliness. These two home-based care programs may improve each other and provide opportunity to further improve quality of life for people living with disabilities and the caregivers. The purpose of this mixed methods study is to adapt and test CAPABLE, an existing evidence-based program, to a new target population with the scalable infrastructure of home-based primary care.

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Any patient currently in JHOME * At risk for or experiencing social isolation as defined by the Lubben Social Network Scale 6 item score less than or equal 12 points or loneliness as defined by the UCLA Loneliness Scale 3 item score of 6 to 9 points * Cognitive inclusion criteria Montreal Cognitive Assessment (MOCA) \>23 as determined by referring JHOME study team member provider * English speaking (measures are standardized in English) * Ability to participate in an approximately 45-60 min virtual or in person meeting * Eligible for CAPABLE * 50 years or older * Not hospitalized over night more than 4 times in the last 12 months * Have some difficulty with any ADL * Cognitively intact * Live in Baltimore County or Baltimore City * Not receiving active cancer treatment * Interested in participating in CAPABLE Care partners will be included if the care partners provide \> 10 hours of care/week Exclusion Criteria: * Terminally ill * live in long term care setting * receiving active cancer treatment Standard of Care/Comparison group Inclusion Criteria: • Any patient currently in JHOME who did not receive the CAPABLE intervention

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living Scale

Timeframe: Baseline, 16 weeks

Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale (IADL)

Timeframe: Baseline, 16 weeks

Change in Pain as assessed by the Brief Pain Inventory Scale (Short Form)

Timeframe: Baseline, 16 weeks

Change in Function as assessed by the American Community Survey Disability Measure

Timeframe: Baseline, 16 weeks

Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)

Timeframe: Baseline, 16 weeks

Change in Social Connection as assessed by the Lubben Social Network Scale

Timeframe: Baseline, 16 weeks

Change in Social Connection as assessed by the University of California Los Angeles (UCLA) Loneliness Scale

Trial details

NCT IDNCT07123298

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05

Contact for this trial

Chloe Wynn, MS

667-208-7444 cwynn3@jh.edu

View on ClinicalTrials.gov More Social Isolation in Older Adults trials

Plain-language summary

Who can participate

Age range

50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living Scale

Timeframe: Baseline, 16 weeks

Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale (IADL)

Timeframe: Baseline, 16 weeks

Change in Pain as assessed by the Brief Pain Inventory Scale (Short Form)

Timeframe: Baseline, 16 weeks

Change in Function as assessed by the American Community Survey Disability Measure

Timeframe: Baseline, 16 weeks

Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)

Timeframe: Baseline, 16 weeks

Change in Social Connection as assessed by the Lubben Social Network Scale

Timeframe: Baseline, 16 weeks

Change in Social Connection as assessed by the University of California Los Angeles (UCLA) Loneliness Scale