- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05187117
CAPABLE Family Pilot - Adapting CAPABLE for Older Adults With Mild Cognitive Impairment (MCI)/Early Stage Dementia and Their Care Partners
CAPABLE Family Pilot
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Samantha Cuerriero
- Phone Number: 410-324-2511
- Email: scurrie6@jhmi.edu
Study Contact Backup
- Name: Emerald Jenkins
- Phone Number: 240-280-9371
- Email: erivers5@jhmi.edu
Study Locations
-
-
Maryland
-
Baltimore, Maryland, United States, 21205
- Johns Hopkins School of Nursing
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Sarah Szanton, PhD, RN, Johns Hopkins School of Nursing
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB00290674
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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