CAPABLE Family Pilot - Adapting CAPABLE for Older Adults With Mild Cognitive Impairment (MCI)/Early Stage Dementia and Their Care Partners

Johns Hopkins University

Status: Completed

Conditions: Impairment, Cognitive; Dementia, Mild; Quality of Life; Mild Cognitive Impairment; Caregiver Burden; Depression; Disability Physical

Treatments: Behavioral: CAPABLE Family - Open Label Pilot; Behavioral: CAPABLE Family - Randomized Control Trial

Study type: Interventional

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

Identifiers

NCT05187117

IRB00290674

Details and patient eligibility

About

The purpose of this study is to test the adapted protocol, CAPABLE Family which builds upon the evidenced based CAPABLE program to address older adults with co-occurring physical disability and mild cognitive impairment or early stage dementia and the older adults' caregivers. It will consist of two phases - an open label pilot and waitlist control trial.

Full description

CAPABLE (NA_00031539) is an evidence-based program that reduces physical disability, but was designed for people who are cognitively intact.

The investigators seek to adapt CAPABLE to meet the needs of older adults with physical disability and mild cognitive impairment and early stage dementia. The investigators also seek to meet the needs of family members who serve as informal caregivers in relation to the physical function of those with cognitive impairment. The purpose of this pilot study is to test a new protocol for a new program, CAPABLE Family, to address older adults with co-occurring physical disability and dementia and the older adults' caregivers.

CAPABLE is a multicomponent goal-directed program that reduces physical disability by working with the person and environment, but was designed for people who are cognitively intact. Based on the Centers for Medicare and Medicaid (CMS) request, the investigators' team briefly included people with mild dementia in the regular CAPABLE protocol. Looking back on that preliminary data, the investigators identified a subset of 12 older adults with mild dementia with Mini-Mental State Examination (MMSE) scores of 23 or below. The investigators found that more than half improved in Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) which is promising but much lower than CAPABLE the rest of the cohorts which suggests the need to adapt CAPABLE for people with dementia. Therefore, the investigators have adapted CAPABLE for people with mild cognitive impairment or early stage dementia calling it CAPABLE Family.

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).

This research study is a continuation of IRB00243117 during which the investigators conducted preliminary activities to design the CAPABLE Family intervention. This study will include two phases, an open label pilot and a randomized control trial. The investigators will collect feedback during the open label pilot from the study team clinicians, older adult participants and care partners to further refine the intervention that will be tested as part of the randomized control trial.

Enrollment: 74 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Have at least 1 ADL disability
• Have mild cognitive impairment or mild dementia (as indicated by clinician diagnosis, subjective cognitive complaints, or Blind/Telephone Montreal Cognitive Assessment (MoCA)(score of 16-23)
• Care partners will be included if they provide >10 hours of care/week
• Live in Baltimore City/County

Exclusion criteria

• Live in long term care setting

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 3 patient groups

Open Label Pilot

Experimental group

Description:

The Open Label Pilot (Phase 4) will include testing the CAPABLE Family intervention with 6 individuals with MCI or early-stage dementia. At least 5 of the 6 older adults will be required to have a family member involved. Assuming all have a family member involved (though one may not), 12 participants will be enrolled in the open label pilot. Open label pilot participants will be asked to provide feedback halfway through the intervention and at the end via phone conversations with the research study team, allowing the study team to make changes accordingly.

Treatment:

Behavioral: CAPABLE Family - Open Label Pilot

Randomized Control Pilot - Intervention Arm

Experimental group

Description:

After the open label pilot, 17 older adults (and if available, care partners) will be randomized to the CAPABLE Family intervention. They will be assessed at baseline, after the 4 month intervention, and after the waitlist control arm.

Treatment:

Behavioral: CAPABLE Family - Randomized Control Trial

Randomized Control Pilot - Waitlist Control Arm

Active Comparator group

Description:

The waitlist control group, 17 older adults and if available, care partners, will receive the intervention after they have served as controls to the immediate treatment group, ensuring all participants have access to the intervention.

Treatment:

Behavioral: CAPABLE Family - Randomized Control Trial