CAPABLE Care + Connect

Johns Hopkins University

Status: Enrolling

Conditions: Homebound Persons; Social Isolation in Older Adults; Quality of Life; Social Isolation or Loneliness; Social Isolation; Disability Physical

Treatments: Behavioral: CAPABLE Care + Connect - Open Label Pilot; Behavioral: CAPABLE Care + Connect - Pilot

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT07123298

IRB00471865

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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450 participants in 3 patient groups

Open-Label Pilot

Experimental group

Description:

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.

Treatment:

Behavioral: CAPABLE Care + Connect - Open Label Pilot

Pilot- Intervention

Experimental group

Description:

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

Treatment:

Behavioral: CAPABLE Care + Connect - Pilot

Standard of Care Group

No Intervention group

Description:

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.