SHARE Adaptation Intervention for African-American Families

Benjamin Rose Institute on Aging

Status: Enrolling

Conditions: Moderate Dementia; Mild Dementia

Treatments: Behavioral: Counseling session and printed resources; Behavioral: 5+1 Adapted, early-stage dyadic care planning intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07208162

BRIA2025SHARE-ROYBAL

1P30AG086562-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Treatment (SHARE Dyadic Intervention)

Experimental group

Description:

Treatment group dyads are comprised of a PLWD with mild to moderate dementia and his/her preferred CG. Following recruitment and the consent process and screening, baseline telephone interviews (T1) with trained interviewers from the Benjamin Rose Institute on Aging will be completed separately with all CGs and PLWDs. Treatment group dyads will receive the culturally adapted SHARE intervention compromised of up to five, 60- 90-minute, curriculum-guided sessions with a SHARE Counselor over a 8-10 week period. A (T2) follow-up interview will be conducted approximately two weeks after treatment group dyads complete their final session;.

Treatment:

Behavioral: 5+1 Adapted, early-stage dyadic care planning intervention

Control (Treatment as usual single session)

Active Comparator group

Description:

Control group dyads are comprised of a PLWD with mild to moderate dementia and his/her preferred CG. Following recruitment and the consent process and screening, baseline telephone interviews (T1) with trained interviewers from the Benjamin Rose Institute on Aging will be completed separately with all CGs and PLWDs. Control group participants will receive a treatment as usual equivalent: a standardized educational and resource single session with a packet of information. A (T2) follow-up interview will be conducted approximately approximately eight weeks after (T1) baseline interviews.

Treatment:

Behavioral: Counseling session and printed resources