CAPABLE Care Partner Pilot Study

NCT05670639 | Completed

• 1 other identifier: IRB00308713
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

This is a small-scale multi-site pilot of a supplemental enhancement called "Care Partner" to the evidence-based CAPABLE program that will involve up to 60 individuals (30 care partners and older adult dyads) and 30 professional staff in organizations currently licensed to provide CAPABLE. This is a qualitative study of a convenience sample of individuals.

Conditions

Aging; Caregiver Burden

Outcome Measures

Primary Outcomes (6)

• Level of acceptance of intervention as assessed by qualitative assessments

  Qualitative interviews with each type of key informant at the end of the pilot will help us understand the level of acceptance of the Care Partner addition by each subject type (i.e., care partner, clinician, administrator). An adjectival scale will be used with 4 points from "Very satisfied to Very unsatisfied" together with open-ended questions.

  10-12 months

• Potential barriers and catalysts in implementation as assessed by key informant interviews with program administrators via semi-structured interview guide

  Potential barriers and catalysts in implementation for incorporating Care Partners into CAPABLE-including the feasibility related to costs, resources, and other factors through key informant interviews with the program administrators using a semi-structured interview guide. An Adjectival scale will be used with 4 points from "Very satisfied to Very unsatisfied" together with open-ended questions.

  10 months

• Change in Depression as assessed by the Patient Health Questionnaire Depression Scale (PHQ-2)

  The PHQ-2 screening instrument contains 2 questions, 4-point Adjectival Likert scale from "Not at all" to "Nearly every day" with the "nearly every day" response indicating more severe depressive symptoms.

  Baseline, 4 months - at the end of the intervention for each care partner

• Change in self-reported health status as assessed by one item in the 12-item Short Form Survey (SF-12)

  The SF-12 is a 12-item questionnaire with a 5-point Likert scale (responses ranging from 'excellent' to 'poor'). The self-report of "fair" or "poor" indicates worse self-reported health status and has shown predictive power associated with higher morbidity or mortality.

  Baseline, 4 months at the completion of the intervention for each care partner

• Change in the perception of caregiving effectiveness as measured by the Caregiving Effectiveness Scale (Noelker)

  Two items from the Caregiving Effectiveness scale with a 4-point adjectival Likert scale (responses ranging from 'very satisfied' to 'not satisfied at all'. A response of "not satisfied at all" indicates lower perception of caregiving effectiveness.

  Baseline, 4 months at the completion of the intervention for each care partner

• Change in caregiving competence and confidence as assessed by the Pearlin's Caregiving Competence Scale.

  Two items using a 5-point adjectival Likert scale (responses ranging from "Strongly disagree to Strongly Agree). A higher score (agreement) would indicate higher competency/satisfaction.

  Baseline, 4 months at completion of the intervention for each care partner

Study Arms (1)

Pilot

OTHER

Behavioral: CAPABLE Care Partner

Interventions

CAPABLE Care Partner BEHAVIORAL

The CAPABLE Care Partner intervention consists of three components: 1) up to 3 sessions with a Care Partner Support person focused on developing action plans for self-care goals of the care partner 2) educational materials provided in a folder at the beginning of the program 3) inclusion in the CAPABLE clinician visits as deemed appropriate by the client, CAPABLE clinicians, and care partner

Pilot

Eligibility Criteria

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

You may qualify if:

• Care Partner:
• Provides 10+ hours/week of care or support for CAPABLE program participant
• Able to participate in two 45 minutes phone interview or virtual meetings
• English-speaking
• CAPABLE Participant:
• CAPABLE participant of one of the CAPABLE programs offered by a pilot site organization
• Able to participate in two 30-minute phone interview or virtual meetings
• English-speaking
• Occupational Therapist (OT)/ Registered Nurse (RN):
• Has been trained to provide CAPABLE and has served CAPABLE clients for at least 6 months
• Currently serving CAPABLE participants
• Able to participate in two one-hour phone call or virtual meetings
• English-speaking
• Care Partner Support Specialist
• Licensed social worker or other professional trained in providing caregiver support

Sponsors & Collaborators

• Johns Hopkins University: lead
• National Institute on Disability, Independent Living, and Rehabilitation Research: collaborator

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Caregiver Burden

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: January 4, 2023
• Study Start: January 10, 2023
• Primary Completion: January 2, 2024
• Study Completion: January 2, 2024
• Last Updated: February 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)