Adapting the SHARE for Dementia Early-Stage Dyadic Intervention: A Stage I Pilot Study With African-American Families
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Attrition
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Research interviewers will be blinded to condition at Baseline (Time 1) only.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Attrition
时间窗: Follow up (T2); within 12 weeks of baseline.
We will assess the number of caregivers and PLWD retained at follow-up
Session length
时间窗: 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
时间窗: After each session; within 10 weeks of baseline.
SHARE counselors will report the number of sessions attended out of 6 treatment sessions offered.
Satisfaction with session
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Follow up (T2); within 12 weeks of baseline.
Caregivers and PLWD will be asked about the main benefits and drawbacks of SHARE.
Goals
时间窗: 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.
次要结局
- Dyadic Relationship Scale (DRS) (Clinical Outcomes (Distal Effects; Secondary))(Baseline (T1), Follow up (T2); within 12 weeks of baseline.)
- Personal and Instrumental Activities of Daily Living (PIADL)(Baseline (T1), Follow up (T2); within 12 weeks of baseline.)
- Emotional-Intimacy Disruptive Behavior Scale (EIDBS)(Baseline (T1), Follow up (T2); within 12 weeks of baseline.)
- Dementia Quality of Life +/- Affect(Baseline (T1), Follow up (T2); within 12 weeks of baseline.)
- Center for Epidemiological Studies Depression Scale (CES-D)(Baseline (T1), Follow up (T2); within 12 weeks of baseline.)
- Stress in Providing Care(Baseline (T1), Follow up (T2); within 12 weeks of baseline.)
- Leisure & Healthy Behaviors(Baseline (T1), Follow up (T2); within 12 weeks of baseline.)
- Quality of Life - AD (QoL-AD)(Baseline (T1), Follow up (T2); within 12 weeks of baseline.)