CAPABLE Care + Connect

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT07123298
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • 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.

Study Details

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.

Key Dates

Start date
Aug 14, 2025
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
450 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

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.

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 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins School of NursingBaltimoreMaryland21205-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins School of Nursing· Baltimore, MD

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