SHARE Adaptation Intervention for African-American Families

NCT07208162 | Recruiting DMC

• 2 other identifiers: BRIA2025SHARE-ROYBAL1P30AG086562-01
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Dementia; Moderate Dementia

Outcome Measures

Primary Outcomes (10)

• Session length

  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.

  After each session; within 10 weeks of baseline.

• Attendance

  SHARE counselors will report the number of sessions attended out of 6 treatment sessions offered.

  After each session; within 10 weeks of baseline.

• Attrition

  We will assess the number of caregivers and PLWD retained at follow-up

  Follow up (T2); within 12 weeks of baseline.

• Satisfaction with session

  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.

  After each session; within 10 weeks of baseline.

• Treatment process

  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.

  Follow up (T2); within 12-weeks of baseline.

• Overall satisfaction

  Caregivers and PLWD will be asked to rate their satisfaction with care values and preferences discussions, spacing between sessions, importance of knowledge gained, etc.

  Follow up (T2); within 12 weeks of baseline.

• Utility

  Caregivers and PLWD will be asked to rate the usefulness of materials and information shared, skill of counselor, commitment to care plan.

  Follow up (T2); within 12 weeks of baseline.

• Feasibility of SHARE

  Caregivers and PLWD will be asked about the appropriateness of time spent in session and number of sessions.

  Follow up (T2); within 12 weeks of baseline.

• Acceptability

  Caregivers and PLWD will be asked about the main benefits and drawbacks of SHARE.

  Follow up (T2); within 12 weeks of baseline.

• Goals

  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.

  Follow up (T2); within 12 weeks of baseline.

Secondary Outcomes (8)

• Dyadic Relationship Scale (DRS) (Clinical Outcomes (Distal Effects; Secondary))

  Baseline (T1), Follow up (T2); within 12 weeks of baseline.

• Personal and Instrumental Activities of Daily Living (PIADL)

  Baseline (T1), Follow up (T2); within 12 weeks of baseline.

• Emotional-Intimacy Disruptive Behavior Scale (EIDBS)

  Baseline (T1), Follow up (T2); within 12 weeks of baseline.

• Dementia Quality of Life +/- Affect

  Baseline (T1), Follow up (T2); within 12 weeks of baseline.

• Center for Epidemiological Studies Depression Scale (CES-D)

  Baseline (T1), Follow up (T2); within 12 weeks of baseline.

Other Outcomes (6)

• Self-Care education (Mechanisms (Proximal Effects; Secondary))

  After each session; within 10 weeks of baseline.

• Communication skills (Mechanisms (Proximal Effects; Secondary))

  After each session; within 10 weeks of baseline.

• Knowledge of Available Service; Service Availability Measure (Mechanisms (Proximal Effects; Secondary))

  Baseline (T1), Follow up (T2); within 12 weeks of baseline.

Study Arms (2)

Treatment (SHARE Dyadic Intervention)

EXPERIMENTAL

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;.

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

Control (Treatment as usual single session)

ACTIVE COMPARATOR

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.

Behavioral: Counseling session and printed resources

Interventions

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

The intervention group will receive the adapted SHARE Dyadic program, consisting of five, 60-90-minute curriculum-guided sessions with a SHARE Counselor, plus one optional family session.

Treatment (SHARE Dyadic Intervention)

Counseling session and printed resources BEHAVIORAL

Control group participants will receive a treatment as usual equivalent: a single, standardized educational and resource session with a packet of information.

Control (Treatment as usual single session)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Benjamin Rose Institute on Aging: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Benjamin Rose

Cleveland, Ohio, 44120, United States

RECRUITING

Study Officials

• Silvia Orsulic-Jeras

  Benjamin Rose Institute on Aging

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Silvia Orsulic-Jeras

CONTACT

2163731625; sjeras@benrose.org

Zoe Fete

CONTACT

2163731929; zfete@benrose.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Research interviewers will be blinded to condition at Baseline (Time 1) only.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized controlled trial with two groups: Treatment (SHARE) and Control (Treatment as usual single session)

Study Record Dates

• First Submitted: August 21, 2025
• First Posted: October 6, 2025
• Study Start: August 19, 2025
• Primary Completion: March 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-08

Locations

US (1)