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| ID | Type | Description | Link |
|---|---|---|---|
| 1P30AG086562-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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;. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Self-Care education (Mechanisms (Proximal Effects; Secondary)) | SHARE counselors will report on dyad's self-care strengths and challenges after sessions 1 & 4 of the treatment intervention. | After each session; within 10 weeks of baseline. |
| Communication skills (Mechanisms (Proximal Effects; Secondary)) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Silvia Orsulic-Jeras | Contact | 2163731625 | sjeras@benrose.org | |
| Zoe Fete | Contact | 2163731929 | zfete@benrose.org |
| Name | Affiliation | Role |
|---|---|---|
| Silvia Orsulic-Jeras | Benjamin Rose Institute on Aging | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benjamin Rose | Recruiting | Cleveland | Ohio | 44120 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2025 | Sep 27, 2025 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 3, 2024 | Sep 25, 2025 | ICF_001.pdf |
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Randomized controlled trial with two groups: Treatment (SHARE) and Control (Treatment as usual single session)
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Research interviewers will be blinded to condition at Baseline (Time 1) only.
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| 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. |
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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. |
| 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. | 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 | 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. | 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. | Baseline (T1), Follow up (T2); within 12 weeks of baseline. |
| Stress in Providing Care | Caregivers will be asked open-ended questions. | 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. | 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. | Baseline (T1), Follow up (T2); within 12 weeks of baseline. |
Communication skills are 4-items that counselors respond to after each session of the treatment intervention to rate the degree of which care partner and PLWD communicated with the counselor, as well as to rate the quality and balance of amount of talking that occurred during the sessions. Response options range from 1 "Not at all" to 7 "very", with higher scores indicating better communication. |
| After each session; within 10 weeks of baseline. |
| Knowledge of Available Service; Service Availability Measure (Mechanisms (Proximal Effects; Secondary)) | The Knowledge of Available Service subscale of the Service Availability Measure is a 14-item measure of the PLWD and their care partner's knowledge of different community of mental health services available. Response are (1) yes and (0) no. Range is 0-14, with higher scores indicating higher knowledge of services available. | Baseline (T1), Follow up (T2); within 12 weeks of baseline. |
| Use of Services; Service Availability Measure (Mechanisms (Proximal Effects; Secondary)) | The Use of Services subscale of the Service Availability Measure is a 14-item measure of the PLWD and their care partner's use of different community of mental health services available in the past 3 months. Response are (1) yes and (0) no. Range is 0-14, with higher scores indicating higher use of services available. | Baseline (T1), Follow up (T2); within 12 weeks of baseline. |
| Care Values; Care Values Scale (CVS) (Mechanisms (Proximal Effects; Secondary)) | The Care Values Scale is a 25-item measure to capture what the PLWD, and their care partners, think are most important to the PLWD's future care. Response options are (1) Not at all important, (2) Somewhat important, (3) Very important. Range is 25-75, with higher scores indicating higher levels of importance to the various domains of care asked. | Baseline (T1), Follow up (T2); within 12 weeks of baseline. |
| Preferences for Care Tasks; Preferences for Care Tasks Scale (PCTS) (Mechanisms (Proximal Effects; Secondary)) | The Preferences for Care Tasks Scale is a 19-item measure to capture who the PLWD, and their care partners believe the PLWD, prefers to help them with various care tasks. Response options are (1) the care giver, (2) friends or other family, (3) paid professional help. Range is 19-57, with higher scores indicating higher preferences that care tasks are performed outside of the dyad. | Baseline (T1), Follow up (T2); within 12 weeks of baseline. |