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NCT Number: NCT07123298

CAPABLE Care + Connect

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.

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Key information

Conditions

Social Isolation in Older Adults Behavior Disability Physical Homebound Persons Quality of Life Social Behavior Social Isolation Social Isolation or Loneliness

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAPABLE Care + Connect - Open Label Pilot

Behavioral

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.

CAPABLE Care + Connect - Pilot

Behavioral

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.

Primary outcomes

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

    Time frame: Baseline, 16 weeks

    6 questions, each 1 point for a total score range of 1- 6. A score closer to 6 indicates high patient independence, better outcome.

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

    Time frame: Baseline, 16 weeks

    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.

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

    Time frame: Baseline, 16 weeks

    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.

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

    Time frame: Baseline, 16 weeks

    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.

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

    Time frame: Baseline, 16 weeks

    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.

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

    Time frame: Baseline, 16 weeks

    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.

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

    Time frame: Baseline, 16 weeks

    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.

  8. Change in Social Connection as assessed by qualitative questions

    Time frame: Baseline, 16 weeks

    2 open ended questions about social network. Qualitatively look at answers from descriptive perspective

  9. Change in Caregiver Burden as assessed by Zarit Burden Inventory

    Time frame: Baseline, 16 weeks

    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.

  10. Change in Perceived Change in Function Scale

    Time frame: 16 weeks

    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.

  11. Change in Caregiver Burden as assessed by the Oberest Caregiver Burden Scale

    Time frame: Baseline, 16 weeks

    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.

  12. Change in Caregiver Outcomes as assessed by the Bakas Caregiving Outcomes Scale

    Time frame: Baseline, 16 weeks

    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.

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

    Time frame: Baseline, 16 weeks

    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.

  14. Change in Pain as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form

    Time frame: Baseline, 16 weeks

    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.

Secondary outcomes

  1. JHOME Health System Effects- Number Urgent Visits

    Time frame: 6 months prior to program, 16 weeks

    Frequency (number) of urgent visits

  2. JHOME Health System Effects- Number Emergency Room Visits

    Time frame: 6 months prior to program, 16 weeks

    Frequency (number) of emergency room visits

  3. JHOME Health System Effects - Nursing Home Placement

    Time frame: 16 weeks

    Yes/No to being placed in nursing home

  4. JHOME Health System Effects- Number of Medications

    Time frame: 6 months prior to program, 16 weeks

    Number of medications prescribed

Other outcomes

  1. JHOME Health System Effects- Number Routine Care Visits

    Time frame: 6 months prior to program, 16 weeks

    Frequency (number) of routine care visits

Study contacts

Contact information is provided by the study sponsor or research team.

Chloe Wynn, MS

CONTACT

[email protected]

667-208-7444

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Disability, Independent Living, and Rehabilitation Research
  • Rita & Alex Hillman Foundation

Registry information

Official study title

CAPABLE Care + Connect: Pilot Feasibility of Implementing CAPABLE Into Homebased Primary Care

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2025
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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