NCT07208162 · Benjamin Rose Institute on Aging
SHARE Adaptation Intervention for African-American Families
(SHARE)
What this study is 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 randomly assigned-control trial wil be confucted to compare the adaptaed SHARE program versus usual care.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
BEHAVIORAL
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 measures
Session length
Time frame: 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
Time frame: After each session; within 10 weeks of baseline.
SHARE counselors will report the number of sessions attended out of 6 treatment sessions offered.
Attrition
Time frame: Follow up (T2); within 12 weeks of baseline.
We will assess the number of caregivers and PLWD retained at follow-up
Satisfaction with session
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Follow up (T2); within 12 weeks of baseline.
Caregivers and PLWD will be asked about the main benefits and drawbacks of SHARE.
Goals
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Cleveland, Ohio
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 6, 2025 · Source of record for eligibility and locations