CAPABLE Care + Connect

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorJohns Hopkins University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

Terminally ill

live in long term care setting

receiving active cancer treatment

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

450 Participants
are divided into 3 treatment groups
Group A: Open-Label PilotExperimental treatment 1 intervention
Group B: Pilot- InterventionExperimental treatment 1 intervention
Group C: Standard of Care GroupNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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
4

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

Secondary outcomes

1

JHOME Health System Effects- Number Urgent Visits

Frequency (number) of urgent visits

Time frame
6 months prior to program, 16 weeks
2

JHOME Health System Effects- Number Emergency Room Visits

Frequency (number) of emergency room visits

Time frame
6 months prior to program, 16 weeks
3

JHOME Health System Effects - Nursing Home Placement

Yes/No to being placed in nursing home

Time frame
16 weeks
4

JHOME Health System Effects- Number of Medications

Number of medications prescribed

Time frame
6 months prior to program, 16 weeks

Other outcomes

1

JHOME Health System Effects- Number Routine Care Visits

Frequency (number) of routine care visits

Time frame
6 months prior to program, 16 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Johns Hopkins University

Lead sponsor

National Institute on Disability, Independent Living, and Rehabilitation Research

Collaborator

Rita & Alex Hillman Foundation

Collaborator