An interventional study of CAPABLE Care + Connect - Open Label Pilot and CAPABLE Care + Connect - Pilot in Social Isolation in Older Adults, Social Isolation or Loneliness and Social Isolation, sponsored by Johns Hopkins University. Recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-02.
Sponsored by Johns Hopkins University · Not applicable, Interventional, and Prevention
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.
CAPABLE is a home-based, interdisciplinary, goal-directed program that reduces physical disability by working with the person and environment. This program has shown improved performance of activities of daily living (ADL), instrumental activities of daily living (IADL), and depression. Coordinating CAPABLE and Johns Hopkins Home-Based Medicine (JHOME) can help address barriers to health, function, and social connection. Amid limited to no evidence-based strategies to address social isolation and loneliness, this study offers a unique opportunity to address this problem. Because CAPABLE addresses environmental and personal needs to improve the ADL and IADL function of people with disabilities, combining the two programs may better enable people who are homebound to more easily navigate and access the home or beyond. Additionally, this effort will enable the investigators to explore the impact of this combined intervention on social isolation and loneliness.
As in CAPABLE (NA_00031539), the delivery characteristics of CAPABLE Family consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW).
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. The investigators seek to explore if the CAPABLE program increases social connection in homebound older adults, and if the benefits of CAPABLE services improve social connections among socially isolated/lonely homebound older adults.
236 studies on the registry are indexed under Social Isolation; 61 are open to participants now.
This study's planned enrollment of 450 is above the median of 80 across 198 interventional studies indexed under Social Isolation.
Browse Social Isolation studies →Johns Hopkins University is the lead sponsor of 1,815 studies on the registry; 315 are open to participants now.
Of its 208 completed or terminated interventional studies of FDA-regulated products, 144 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Standard of Care/Comparison group Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The Open Label Pilot will include testing the CAPABLE Care + Connect intervention on a total of 8. The investigators will recruit and provide CAPABLE to four caregiver-patient dyads (eight participants) and four older adults without caregivers.
Behavioral: CAPABLE Care + Connect - Open Label Pilot
The investigators will recruit fifteen new partner-patient dyads and fifteen participants without caregivers to receive CAPABLE. That is a total of 45 participants that will receive the CAPABLE intervention
Behavioral: CAPABLE Care + Connect - Pilot
The standard of care/comparison group will apply for JHOME patients. There are currently around 400-450 patients in JHOME, therefore, our total sample size including both intervention and standard of care group will be up to 450 people. It is important to note that the standard of care group is for individuals who did not complete the intervention and is used to evaluate the effectiveness of the intervention itself. Those eligible for the intervention will be included in the study, whereas those ineligible based on intervention screen will be asked about record review. If those ineligible decline record review, those ineligible will be excluded from entire study.
As in CAPABLE, the delivery characteristics of CAPABLE Care + Connect consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW). Adaptations targeting those in JHOME will be made on a per-client basis as part of the open-label pilot. The investigators will further refine and develop the intervention by receiving feedback from the open label pilot participants and CAPABLE clinicians who implemented the pilot to gain those perspectives of the acceptability and feasibility of implementing the CAPABLE Care + Connect intervention. Based on this feedback, the study team will have developed an adapted iteration of the prototype.
As in CAPABLE, the delivery characteristics of CAPABLE Care + Connect consist of an assessment-driven, individually tailored package of interventions delivered over the course of 4 months by an occupational therapist (OT) (\~6 home visits for ≤ 1hour), a registered nurse (RN) (\~4 home visits for ≤ 1hour) and a handy worker (HW). Refinements based on the open label pilot results will be included.
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living Scale
6 questions, each 1 point for a total score range of 1- 6. A score closer to 6 indicates high patient independence, better outcome.
Time frame: Baseline, 16 weeks
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale (IADL)
Participants rate their ability to perform daily tasks on a 5-point scale (1 = no difficulty, 2 = a little difficulty, 3 = moderate difficulty, 4 = a lot of difficulty, 5 = unable to do). Score range 8 to 40, higher scores represent greater difficulty performing ADLs, worse outcome.
Time frame: Baseline, 16 weeks
Change in Pain as assessed by the Brief Pain Inventory Scale (Short Form)
The Brief Pain Inventory - Short Form is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain. Score range 0-90, higher score worse outcome.
Time frame: Baseline, 16 weeks
Change in Function as assessed by the American Community Survey Disability Measure
This measure is used to identify whether a person is considered to have a disability based on responses to six standardized questions. A person is considered to have a disability if the person answers "Yes" to at least one of the six questions. There is no composite score.
Time frame: Baseline, 16 weeks
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
The PHQ-8 contains 8 questions, with a 0-3 scale. A score of 10 or greater is considered major depression, 20 or more is severe major depression. Score range 0-24, higher score worse outcome.
Time frame: Baseline, 16 weeks
Change in Social Connection as assessed by the Lubben Social Network Scale
The Lubben Social Network Scale - 12 item version (LSNS-12) includes 12 questions, each scored from 0 to 5 based on the number of social contacts, with total scores ranging from 0 to 60, where lower scores indicate greater social isolation, worse outcome.
Time frame: Baseline, 16 weeks
Change in Social Connection as assessed by the University of California Los Angeles (UCLA) Loneliness Scale
The UCLA Loneliness Scale (20-item version) includes 20 questions, each rated on a 1 to 4 scale, with total scores ranging from 20 to 80, where higher scores indicate greater perceived loneliness, worse outcome.
Time frame: Baseline, 16 weeks
Change in Social Connection as assessed by qualitative questions
2 open ended questions about social network. Qualitatively look at answers from descriptive perspective
Time frame: Baseline, 16 weeks
Change in Caregiver Burden as assessed by Zarit Burden Inventory
The Zarit Burden Interview - 12 item version includes 12 questions, each scored from 0 (never) to 4 (nearly always), for a total score range of 0 to 48, with higher scores indicating greater caregiver burden, worse outcome.
Time frame: Baseline, 16 weeks
Change in Perceived Change in Function Scale
14 questions related to perceived improvement in function. Scale of -2 (gotten much worse) to 2 (improved a lot). The higher the overall score, the greater the improvement, better outcome.
Time frame: 16 weeks
Change in Caregiver Burden as assessed by the Oberest Caregiver Burden Scale
The Oberst Caregiver Burden Scale includes 15 items rated on a 5-point scale assessing the time and difficulty of caregiving tasks, with total scores ranging from 15 to 75 per subscale and higher scores indicating greater burden.
Time frame: Baseline, 16 weeks
Change in Caregiver Outcomes as assessed by the Bakas Caregiving Outcomes Scale
The Bakas Caregiving Outcomes Scale includes 15 items, each rated on a 7-point scale from -3 (changed for the worst) to +3 (changed for the best), with total scores reflecting the caregiver's perceived changes in life due to caregiving. Higher score better.
Time frame: Baseline, 16 weeks
Change in Pain as assessed by the Brief Pain Inventory (Short Form)
The Brief Pain Inventory - Short Form is a 9 item self-administered questionnaire used to evaluate the severity of a patient's pain and the impact of this pain on the patient's daily functioning on a 10 point scale. 0 = no pain and 10 indicates the worst imaginable pain. Higher score worse outcome.
Time frame: Baseline, 16 weeks
Change in Pain as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form
The PROMIS Pain Interference Short Form includes 6 questions, each rated on a 5-point scale, with raw scores summed and converted to a T-score, where higher scores indicate greater interference from pain in daily activities.
Time frame: Baseline, 16 weeks
JHOME Health System Effects- Number Urgent Visits
Frequency (number) of urgent visits
Time frame: 6 months prior to program, 16 weeks
JHOME Health System Effects- Number Emergency Room Visits
Frequency (number) of emergency room visits
Time frame: 6 months prior to program, 16 weeks
JHOME Health System Effects - Nursing Home Placement
Yes/No to being placed in nursing home
Time frame: 16 weeks
JHOME Health System Effects- Number of Medications
Number of medications prescribed
Time frame: 6 months prior to program, 16 weeks
JHOME Health System Effects- Number Routine Care Visits
Frequency (number) of routine care visits
Time frame: 6 months prior to program, 16 weeks
Plan to share: No
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Started Aug 2025 (actual). Primary completion is estimated for May 2027, 21 months after the start.
Of 155 non-industry interventional studies with no phase under Social Isolation, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 21 months is above that.
Counting every sponsor, half of 156 studies reached it within 18 months; a quarter within 10 and three quarters within 36.
How these figures are worked out, and which studies are left out of them.
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