Recruiting

CAPABLE

Sponsor:

Johns Hopkins University

Code:

NCT07123298

Conditions

Social Isolation in Older Adults

Social Isolation or Loneliness

Social Isolation

Quality of Life

Disability Physical

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

CAPABLE Care + Connect - Open Label Pilot

CAPABLE Care + Connect - Pilot

Study Details

Brief 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.

Conditions

Social Isolation in Older Adults

Social Isolation or Loneliness

Social Isolation

Quality of Life

Disability Physical

Study ID

NCT07123298

Start date

Aug 14, 2025

Status verified date

Jun, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

450 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Open-Label Pilot

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.

experimental: Pilot- Intervention

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

no intervention: Standard of Care Group

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.

Interventions

CAPABLE Care + Connect - Open Label Pilot

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

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 outcome measure

  • Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living Scale [ Time Frame: Baseline, 16 weeks ]
  • Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale (IADL) [ Time Frame: Baseline, 16 weeks ]
  • Change in Pain as assessed by the Brief Pain Inventory Scale (Short Form) [ Time Frame: Baseline, 16 weeks ]
  • Change in Function as assessed by the American Community Survey Disability Measure [ Time Frame: Baseline, 16 weeks ]
  • Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8) [ Time Frame: Baseline, 16 weeks ]
  • Change in Social Connection as assessed by the Lubben Social Network Scale [ Time Frame: Baseline, 16 weeks ]
  • Change in Social Connection as assessed by the University of California Los Angeles (UCLA) Loneliness Scale [ Time Frame: Baseline, 16 weeks ]
  • Change in Social Connection as assessed by qualitative questions [ Time Frame: Baseline, 16 weeks ]
  • Change in Caregiver Burden as assessed by Zarit Burden Inventory [ Time Frame: Baseline, 16 weeks ]
  • Change in Perceived Change in Function Scale [ Time Frame: 16 weeks ]
  • Change in Caregiver Burden as assessed by the Oberest Caregiver Burden Scale [ Time Frame: Baseline, 16 weeks ]
  • Change in Caregiver Outcomes as assessed by the Bakas Caregiving Outcomes Scale [ Time Frame: Baseline, 16 weeks ]
  • Change in Pain as assessed by the Brief Pain Inventory (Short Form) [ Time Frame: Baseline, 16 weeks ]
  • Change in Pain as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference Short Form [ Time Frame: Baseline, 16 weeks ]

Central Contacts and Locations

Central contacts

Chloe Wynn, MS

667-208-7444cwynn3@jh.edu

Locations

Johns Hopkins School of Nursing

Recruiting

Baltimore, Maryland, United States, 21205

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 2, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-16. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-02. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.