Recruiting

SHARE vs. Usual Care

Sponsor:

Benjamin Rose Institute on Aging

Code:

NCT07208162

Conditions

Mild Dementia

Moderate Dementia

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Counseling session and printed resources

Study Details

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

Study ID

NCT07208162

Start date

Aug 19, 2025

Status verified date

Aug, 2025

Completion date

Jul, 2026

Anticipated

Primary completion date

Mar 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (SHARE Dyadic Intervention)

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;.

active comparator: Control (Treatment as usual single session)

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.

Interventions

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

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.

Counseling session and printed resources

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

Primary outcome measure

  • Session length [ Time Frame: After each session; within 10 weeks of baseline. ]
  • Attendance [ Time Frame: After each session; within 10 weeks of baseline. ]
  • Attrition [ Time Frame: Follow up (T2); within 12 weeks of baseline. ]
  • Satisfaction with session [ Time Frame: After each session; within 10 weeks of baseline. ]
  • Treatment process [ Time Frame: Follow up (T2); within 12-weeks of baseline. ]
  • Overall satisfaction [ Time Frame: Follow up (T2); within 12 weeks of baseline. ]
  • Utility [ Time Frame: Follow up (T2); within 12 weeks of baseline. ]
  • Feasibility of SHARE [ Time Frame: Follow up (T2); within 12 weeks of baseline. ]
  • Acceptability [ Time Frame: Follow up (T2); within 12 weeks of baseline. ]
  • Goals [ Time Frame: Follow up (T2); within 12 weeks of baseline. ]

Central Contacts and Locations

Central contacts

Silvia Orsulic-Jeras

2163731625sjeras@benrose.org

Zoe Fete

2163731929zfete@benrose.org

Locations

Benjamin Rose

Recruiting

Cleveland, Ohio, United States, 44120

Contacts

Donna Salaam

216-373-1747dsalaam@benrose.org

Zoe Fete

216-373-1929zfete@benrose.org

Principal Investigator:

Silvia Orsulic-Jeras

More Information

Sponsor

Benjamin Rose Institute on Aging

Last update posted

Oct 6, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Benjamin Rose Institute on Aging on 2025-10-06.