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

February 5, 2024 updated by: Johns Hopkins University

CAPABLE Family Pilot

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins School of Nursing

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open Label Pilot

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.

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).

Adaptations for cognitive decline will be made on a per-client basis as part of the open-label pilot. Topics of adaptations include problem areas addresses, care partner involvement, length/frequency of visits, types of assessments and questions asked, and brainstorming/action planning structure.

Experimental: Randomized Control Pilot - Intervention Arm
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.
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). Refinements based on the open label pilot results will be included.
Active Comparator: Randomized Control Pilot - Waitlist Control Arm
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.
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). Refinements based on the open label pilot results will be included.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living
Time Frame: Baseline, 16 weeks, 32 weeks
6 questions, each 1 point for a total score of 6. A score closer to 6 indicates high patient independence.
Baseline, 16 weeks, 32 weeks
Change in Function as assessed by Lawton & Brody's assessment of Instrumental Activities of Daily Living Scale
Time Frame: Baseline, 16 weeks, 32 weeks
The assessment contains 8 questions with answers that are either a score of 0 or 1. A summary score ranges from 0 (low function, dependent) to 8 (high function, independent) for women and 0 through 5 for men to avoid potential gender bias.
Baseline, 16 weeks, 32 weeks
Change in Pain as assessed by the Brief Pain Inventory (Short Form)
Time Frame: Baseline, 16 weeks, 32 weeks
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. The patient is asked to rate their worst, least, average, and current pain intensity, list current treatments and their perceived effectiveness, and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10 point scale. For the 10 point scale, 0 indicated no pain and 10 indicates the worst imaginable pain.
Baseline, 16 weeks, 32 weeks
Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-8)
Time Frame: Baseline, 16 weeks, 32 weeks
The PHQ-8 contains 8 questions, with a 0-3 scale. A score of 10 or greater is considered major depression, 20 or more is severe major depression.
Baseline, 16 weeks, 32 weeks
Change in caregiving burden as assessed by the Perceived Change Index Scale
Time Frame: 16 weeks, 32 weeks
The Perceived Change Index Scale contains13 questions related to change in caregiver self-improvement wellbeing. Each rated on a scale of 1-5, 1 indicating much worse, 5 indicating improved a lot. The higher the overall score, the greater the improvement.
16 weeks, 32 weeks
Change in Perceived Change in Function Scale Score
Time Frame: 16 weeks, 32 weeks
14 questions related to perceived improvement in function. Scale of -2 (gotten much worse) to 2 (improved a lot). The higher the overall score, the greater the improvement.
16 weeks, 32 weeks
Satisfaction at midpoint of intervention assessed by qualitative questions
Time Frame: 8 weeks
Older Adult and Care Partner Satisfaction at midpoint of intervention assessed by qualitative questions. Qualitative questions will help us understand how best to tailor the intervention for the randomized control pilot.
8 weeks
Satisfaction at endpoint of intervention as assessed by qualitative questions
Time Frame: 16 weeks
Older Adult and Care Partner Satisfaction at endpoint of intervention assessed by qualitative questions. Qualitative questions will help us understand how best to tailor the intervention for the randomized control pilot.
16 weeks
Level of Cognitive Impairment for eligibility as assessed by the Montreal Cognitive Assessment (MoCA) Blind/Telephone
Time Frame: Baseline
Scoring for the Blind/Telephone assessment is out of 22. Score of 12-17 indicates Mild Cognitive Impairment/Early Stage Dementia and is the eligibility requirement for participation in the study.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Sarah Szanton, PhD, RN, Johns Hopkins School of Nursing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 9, 2022

Primary Completion (Estimated)

April 8, 2024

Study Completion (Estimated)

April 8, 2024

Study Registration Dates

First Submitted

December 22, 2021

First Submitted That Met QC Criteria

December 22, 2021

First Posted (Actual)

January 11, 2022

Study Record Updates

Last Update Posted (Estimated)

February 7, 2024

Last Update Submitted That Met QC Criteria

February 5, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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