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

NCT05187117 | Completed

• 1 other identifier: IRB00290674
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (9)

• Change in Function as assessed by the Katz Index of Independence in Activities of Daily Living

  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

  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)

  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)

  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

  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

  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

  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

  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

  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

Study Arms (3)

Open Label Pilot

EXPERIMENTAL

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.

Behavioral: CAPABLE Family - Open Label Pilot

Randomized Control Pilot - Intervention Arm

EXPERIMENTAL

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.

Behavioral: CAPABLE Family - Randomized Control Trial

Randomized Control Pilot - Waitlist Control Arm

ACTIVE COMPARATOR

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.

Behavioral: CAPABLE Family - Randomized Control Trial

Interventions

CAPABLE Family - Open Label Pilot BEHAVIORAL

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.

Open Label Pilot

CAPABLE Family - Randomized Control Trial BEHAVIORAL

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.

Randomized Control Pilot - Intervention Arm; Randomized Control Pilot - Waitlist Control Arm

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Live in long term care setting

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator
• The Rita and Alex Hillman Foundation: collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• 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.

  PMID: 24685996 BACKGROUND

MeSH Terms

Conditions

Dementia; Lymphoma, Follicular; Cognitive Dysfunction; Caregiver Burden; Depression

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Cognition Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Sarah Szanton, PhD, RN

  Johns Hopkins School of Nursing

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The assessment collector will be blinded as to whether a participant is in the intervention or waitlist group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Waitlist Control Trial

Study Record Dates

• First Submitted: December 22, 2021
• First Posted: January 11, 2022
• Study Start: March 9, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)