Clinical trial NCT05187117: CAPABLE Family Pilot - Adapting CAPABLE for Older Adults With Mild Cognitive Impairment (MCI)/Early Stage Dementia and Their Care Partners
Official title: CAPABLE Family Pilot
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dementia, Mild
Mild Cognitive Impairment
Disability Physical
Impairment, Cognitive
Caregiver Burden
Quality of Life
Depression
Keywords: Activities of Daily Living
Instrumental Activities of Daily Living
Caregiving
Physical Function
Executive Function
Home
Intervention
Mild Cognitive Impairment
Early Dementia
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Institute on Disability, Independent Living, and Rehabilitation Research
name: The Rita and Alex Hillman Foundation
First posted: 2022-01-11
Enrollment: 74
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist Control Trial
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Pain as assessed by the Brief Pain Inventory (Short Form)
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
timeFrame: Baseline, 16 weeks, 32 weeks
measure: Change in caregiving burden as assessed by the Perceived Change Index Scale
timeFrame: 16 weeks, 32 weeks
measure: Change in Perceived Change in Function Scale Score
timeFrame: 16 weeks, 32 weeks
measure: Satisfaction at midpoint of intervention assessed by qualitative questions
timeFrame: 8 weeks
measure: Satisfaction at endpoint of intervention as assessed by qualitative questions
timeFrame: 16 weeks
measure: Level of Cognitive Impairment for eligibility as assessed by the Montreal Cognitive Assessment (MoCA) Blind/Telephone
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins School of Nursing
state: Maryland
Study officials:
affiliation: Johns Hopkins School of Nursing
name: Sarah Szanton, PhD, RN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Szanton SL, Wolff JW, Leff B, Thorpe RJ, Tanner EK, Boyd C, Xue Q, Guralnik J, Bishai D, Gitlin LN. CAPABLE trial: a randomized controlled trial of nurse, occupational therapist and handyman to reduce disability among older adults: rationale and design. Contemp Clin Trials. 2014 May;38(1):102-12. doi: 10.1016/j.cct.2014.03.005. Epub 2014 Mar 28.