SHARE Adaptation Intervention for African-American Families

Not Applicable

Recruiting

• Conditions: Mild Dementia; Moderate Dementia

• Registration Number: NCT07208162
• Lead Sponsor: Benjamin Rose Institute on Aging

Brief Summary

This project aims to culturally adapt the SHARE program for African-Americans in early-moderate stage dementia and their care partner. Upon completion of the adaptation, a pilot randomized-control trial wil be confucted to compare the adaptaed SHARE program versus usual care.

Detailed Description

Aim 1: Review SHARE for Dementia materials with an Advisory Committee (AC; 6-10 African Americans with lived experience and experts) to identify distinct needs of African American care dyads and culturally adapt SHARE using this input. Deliverables: Develop SHARE V1 Culturally tailored V1 SHARE Counselor Manual, V1 SHARE Guide for Families, and V1 SHARE Counselor training Aim 2: Conduct focus groups with African American care dyads (n=2 groups; n=10 dyads total, or until saturation) and community service provider staff (n= 2 groups; n=10, or until saturation) to identify strengths and limitations of the V1 SHARE materials, procedures, and protocols. Deliverables: SHARE for African Americans (Version 2;V2); Culturally tailored V2 SHARE Counselor Manual, V2 SHARE Guide for Families, and V2 SHARE Counselor training Aim 3: Train SHARE counselors (n=20) to implement V2 of SHARE. Aim 4: Examine: a) the acceptability and feasibility and; 2) preliminary efficacy of the culturally adapted V2 of SHARE in a fully powered trial with 120 African American care dyads.

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-19
• Study First Submitted: 2025-08-21
• Study First Submitted QC: 2025-09-28
• Last Update Submitted: 2025-09-28
• Study First Posted: 2025-10-06
• Last Update Posted: 2025-10-06
• Primary Completion: 2026-03-30
• Study Completion: 2026-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• African American dyads (both the caregivers and the care-recipient, an individual with an early-stage memory impairing condition (e.g., Alzheimer's disease, vascular dementia, cognitive impairment, etc.)
• Care-recipient lives at home.
• The caregiver (CG) and/or the person with dementia (PWD), or symptoms of memory loss must identify as African American.
• PWD must be at least 50 years old and CGs 18 or older,
• Ability to speak and read English,
• Experiencing signs and symptoms of mild to moderate dementia through family caregiver report on the Dementia Severity Rating Scale and meeting the National Institute on Aging and the Alzheimer's Association clinical criteria for probable AD.

Exclusion Criteria

• A mental health condition (e.g., schizophrenia, bipolar disorder, major depression)
• A traumatic brain injury
• Intellectual or developmental disability
• Individuals experiencing extreme difficulty adjusting and coping to the diagnosis • Individuals living in an institutional setting

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Attrition	Follow up (T2); within 12 weeks of baseline.	We will assess the number of caregivers and PLWD retained at follow-up
Session length	After each session; within 10 weeks of baseline.	SHARE counselors will report length of each session, and we will determine the number of sessions conducted were within 60-90 minutes - the prescribed treatment protocol.
Attendance	After each session; within 10 weeks of baseline.	SHARE counselors will report the number of sessions attended out of 6 treatment sessions offered.
Satisfaction with session	After each session; within 10 weeks of baseline.	Caregivers and PLWD will be asked about their satisfaction with SHARE regarding the: 1) experience; 2) counselor; 3) materials; 4) sessions; 5) postintervention relationship functioning.
Treatment process	Follow up (T2); within 12-weeks of baseline.	Caregivers and PLWD will be asked to agree or disagree with statements about SHARE Counselor, understanding of choices, knowledge of dementia, connection to care partner.
Overall satisfaction	Follow up (T2); within 12 weeks of baseline.	Caregivers and PLWD will be asked to rate their satisfaction with care values and preferences discussions, spacing between sessions, importance of knowledge gained, etc.
Utility	Follow up (T2); within 12 weeks of baseline.	Caregivers and PLWD will be asked to rate the usefulness of materials and information shared, skill of counselor, commitment to care plan.
Feasibility of SHARE	Follow up (T2); within 12 weeks of baseline.	Caregivers and PLWD will be asked about the appropriateness of time spent in session and number of sessions.
Acceptability	Follow up (T2); within 12 weeks of baseline.	Caregivers and PLWD will be asked about the main benefits and drawbacks of SHARE.
Goals	Follow up (T2); within 12 weeks of baseline.	Caregivers and PLWD will be asked to indicate their goals of participating in SHARE, such as: Dementia education, communication skills, knowledge of resources, building a network of support, etc.

Secondary Outcome Measures

Name	Time	Method
Dyadic Relationship Scale (DRS) (Clinical Outcomes (Distal Effects; Secondary))	Baseline (T1), Follow up (T2); within 12 weeks of baseline.	The Dyadic Relationship Scale consists of 28 items that asks care partners and PLWD how often of the time (15-items), and how often in the past month (13-items), they think a statement applies to their relationship. Responses are (0-3) ranging from "All or nearly all of the time" to "None or almost none of the time". Ranges are a total of 0-84, with higher scores indicating more positive dyadic relationship.
Personal and Instrumental Activities of Daily Living (PIADL)	Baseline (T1), Follow up (T2); within 12 weeks of baseline.	The Personal and Instrument Activities of Daily Living is a an 18-item measure that asks care partners to rate the PLWD ability to perform daily activities. Responses are (1) Does by self/ Needs no help, (2) Needs reminders/ Needs a little help, (3) Needs help most of the time, and (4) Needs help all the time (unable to do activity). Range is from 18-72, with lower scores indicating less ability of PLWD to perform daily activities independently.
Emotional-Intimacy Disruptive Behavior Scale (EIDBS)	Baseline (T1), Follow up (T2); within 12 weeks of baseline.	The Emotional-Intimacy Disruptive Behavior Scale is a an 8-item measure to asks care givers and PLWD to assess the extent care partners with hold or distort symptoms or feelings to protect their care partner. Response options are (1) None of the time, (2) Some of the time, (3) Much of the time, (4) Most or all of the time. Range is from 8-32, with higher scores indicating higher distortions of feelings
Dementia Quality of Life +/- Affect	Baseline (T1), Follow up (T2); within 12 weeks of baseline.	Caregivers and PLWD will be asked six positive/six negative affect indicators.
Center for Epidemiological Studies Depression Scale (CES-D)	Baseline (T1), Follow up (T2); within 12 weeks of baseline.	Caregivers and PLWD will be asked to respond to a 20-item measure of how often in past week they experience depressive symptoms associated with depression, such as restless sleep, poor appetite, and feeling lonely. Response options range from 0 to 3 for each item (0 = Rarely or None of the Time, 1 = Some or Little of the Time, 2 = Moderately or Much of the time, 3 = Most or Almost All the Time). Scores range from 0 to 60, with high scores indicating greater depressive symptoms.
Stress in Providing Care	Baseline (T1), Follow up (T2); within 12 weeks of baseline.	Caregivers will be asked open-ended questions.
Leisure & Healthy Behaviors	Baseline (T1), Follow up (T2); within 12 weeks of baseline.	Caregivers and PLWD will complete an inventory of enjoyable activities and self-care practices.
Quality of Life - AD (QoL-AD)	Baseline (T1), Follow up (T2); within 12 weeks of baseline.	Caregivers and PLWD will respond to a 13-item questionnaire designed to provide a report of the quality of life for the PLWD participant. Response options are from 1 (Poor) - (4) excellent for each item. Range from 13-52, higher scores indicate higher quality of life.

Trial Locations

Locations (1)

Benjamin Rose; 🇺🇸 Cleveland, Ohio, United States