Mild DementiaSHARENCT07208162
SHARE Adaptation Intervention for African-American Families
A study testing 5+1 Adapted, early-stage dyadic care planning intervention and Counseling session and printed resources in people with Mild Dementia and Moderate Dementia, run by Benjamin Rose Institute on Aging at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Dementia, Moderate Dementia
- What is being tested?
- 5+1 Adapted, early-stage dyadic care planning intervention and Counseling session and printed resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Aug 2025to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Benjamin Rose
Cleveland, Ohio, 44120
Donna Salaam, 216-373-1747, dsalaam@benrose.org
Zoe Fete, 216-373-1929, zfete@benrose.org
About this study
Official title: Adapting the SHARE for Dementia Early-Stage Dyadic Intervention: A Stage I Pilot Study With African-American Families
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.
Read the 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.
- Conditions
- Mild Dementia, Moderate Dementia
- Being tested
- 5+1 Adapted, early-stage dyadic care planning intervention, Counseling session and printed resources
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5+1 Adapted, early-stage dyadic care planning interventionBehavioural
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 resourcesBehavioural
Control group participants will receive a treatment as usual equivalent: a single, standardized educational and resource session with a packet of information.
| Study group | Role | What they receive |
|---|---|---|
| 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;. Receives: 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. Receives: Behavioral: Counseling session and printed resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: After each session; within 10 weeks of baseline.
Attendance
SHARE counselors will report the number of sessions attended out of 6 treatment sessions offered.
Measured: After each session; within 10 weeks of baseline.
Attrition
We will assess the number of caregivers and PLWD retained at follow-up
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Follow up (T2); within 12 weeks of baseline.
Acceptability
Caregivers and PLWD will be asked about the main benefits and drawbacks of SHARE.
Measured: 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.
Measured: Follow up (T2); within 12 weeks of baseline.
Secondary outcomes (8)
Dyadic Relationship Scale (DRS) (Clinical Outcomes (Distal Effects; Secondary))
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.
Measured: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Personal and Instrumental Activities of Daily Living (PIADL)
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.
Measured: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Emotional-Intimacy Disruptive Behavior Scale (EIDBS)
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
Measured: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Dementia Quality of Life +/- Affect
Caregivers and PLWD will be asked six positive/six negative affect indicators.
Measured: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Center for Epidemiological Studies Depression Scale (CES-D)
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.
Measured: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Stress in Providing Care
Caregivers will be asked open-ended questions.
Measured: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Leisure & Healthy Behaviors
Caregivers and PLWD will complete an inventory of enjoyable activities and self-care practices.
Measured: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Quality of Life - AD (QoL-AD)
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.
Measured: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start19 Aug 2025
- Primary completion30 Mar 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with two groups: Treatment (SHARE) and Control (Treatment as usual single session)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benjamin Rose Institute on Aging
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Silvia Orsulic-Jeras, Principal investigator, Benjamin Rose Institute on Aging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208162
- Sponsor's protocol ID
- BRIA2025SHARE-ROYBAL
- Other IDs
- 1P30AG086562-01
- Acronym
- SHARE
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting the SHARE for Dementia Early-Stage Dyadic Intervention: A Stage I Pilot Study With African-American Families
- ClinicalTrials.gov ID
- NCT07208162
- Acronym / sponsor ID
- SHARE / BRIA2025SHARE-ROYBAL
- Conditions
- Mild Dementia, Moderate Dementia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Benjamin Rose Institute on AgingUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 19 Aug 2025 (actual)
- Primary completion
- 30 Mar 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 6 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial with two groups: Treatment (SHARE) and Control (Treatment as usual single session)
| Arm | Type | Receives |
|---|---|---|
| Treatment (SHARE Dyadic Intervention) | Experimental | Behavioral: 5+1 Adapted, early-stage dyadic care planning interventionTreatment 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;. |
| Control (Treatment as usual single session) | Active comparator | Behavioral: Counseling session and printed resourcesControl 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5+1 Adapted, early-stage dyadic care planning interventionThe 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. | Behavioural | Treatment (SHARE Dyadic Intervention) |
| Counseling session and printed resourcesControl group participants will receive a treatment as usual equivalent: a single, standardized educational and resource session with a packet of information. | Behavioural | Control (Treatment as usual single session) |
Primary outcome
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.
8 secondary outcomes
Dyadic Relationship Scale (DRS) (Clinical Outcomes (Distal Effects; Secondary))
Time frame: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Personal and Instrumental Activities of Daily Living (PIADL)
Time frame: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Emotional-Intimacy Disruptive Behavior Scale (EIDBS)
Time frame: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Dementia Quality of Life +/- Affect
Time frame: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Center for Epidemiological Studies Depression Scale (CES-D)
Time frame: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Stress in Providing Care
Time frame: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Leisure & Healthy Behaviors
Time frame: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Quality of Life - AD (QoL-AD)
Time frame: Baseline (T1), Follow up (T2); within 12 weeks of baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2025.
Related trials for Mild Dementia
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Not yet recruitingObservational study
Prospective Research on Identification of Dementia in Early Stages (P.R.I.D.E)
Mild Cognitive Impairment, Memory Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Silvia Orsulic-Jeras principal investigator
Benjamin Rose Institute on Aging
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5+1 Adapted, early-stage dyadic care planning intervention and Counseling session and printed resources in people with Mild Dementia and Moderate Dementia, run by Benjamin Rose Institute on Aging at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Silvia Orsulic-Jeras (2163731625, sjeras@benrose.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Session length (time frame: After each session; within 10 weeks of baseline.). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2025.