SHARE Adaptation Intervention for African-American Families

Официальное название

Adapting the SHARE for Dementia Early-Stage Dyadic Intervention: A Stage I Pilot Study With African-American Families

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.
• Поведенческое 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.

Первичные конечные точки

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

Вторичные конечные точки (8)

• Dyadic Relationship Scale (DRS) (Clinical Outcomes (Distal Effects; Secondary)) [Срок оценки: Baseline (T1), Follow up (T2); within 12 weeks of baseline.]
• Personal and Instrumental Activities of Daily Living (PIADL) [Срок оценки: Baseline (T1), Follow up (T2); within 12 weeks of baseline.]
• Emotional-Intimacy Disruptive Behavior Scale (EIDBS) [Срок оценки: Baseline (T1), Follow up (T2); within 12 weeks of baseline.]
• Dementia Quality of Life +/- Affect [Срок оценки: Baseline (T1), Follow up (T2); within 12 weeks of baseline.]
• Center for Epidemiological Studies Depression Scale (CES-D) [Срок оценки: Baseline (T1), Follow up (T2); within 12 weeks of baseline.]
• Stress in Providing Care [Срок оценки: Baseline (T1), Follow up (T2); within 12 weeks of baseline.]
• Leisure & Healthy Behaviors [Срок оценки: Baseline (T1), Follow up (T2); within 12 weeks of baseline.]
• Quality of Life - AD (QoL-AD) [Срок оценки: Baseline (T1), Follow up (T2); within 12 weeks of baseline.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Benjamin Rose — Cleveland

Идентификаторы

NCT: NCT07208162 · BRIA2025SHARE-ROYBAL · 1P30AG086562-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗