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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
CAPABLE Care + Connect - Open Label Pilot
BehavioralAs 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
BehavioralAs 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
Trial outcomes
Primary outcomes
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.
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.
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.
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.
Secondary outcomes
JHOME Health System Effects- Number Urgent Visits
Frequency (number) of urgent visits
JHOME Health System Effects- Number Emergency Room Visits
Frequency (number) of emergency room visits
JHOME Health System Effects - Nursing Home Placement
Yes/No to being placed in nursing home
JHOME Health System Effects- Number of Medications
Number of medications prescribed
Other outcomes
JHOME Health System Effects- Number Routine Care Visits
Frequency (number) of routine care visits
Sponsors and contacts
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Johns Hopkins University
Lead sponsor
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborator
Rita & Alex Hillman Foundation
Collaborator