Culturally Tailoring the Delivery of an Evidence-Based Diabetes Self-Management Program for Black Adults to Enhance Its Reach, Adoption, Implementation, and Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Recruitment: Number of Miles Participants are Willing to Travel for a Workshop
研究概览
简要总结
The goal of the study is to conduct the Healthy Living with Diabetes (HLWD) program among Black individuals in a culturally appropriate manner. This study will involve 24-30 participants in total. Participants can expect to be on study for approximately 6 months.
详细描述
The study objectives are to recruit and empower Black Healthy Living with Diabetes (HLWD) facilitators to deliver culturally tailored HLWD content and pilot the culturally tailored HLWD program, using the RE-AIM framework and Proctor implementation outcomes to gather preliminary implementation data. The study team will partner with stakeholders and community organizations serving Black adults, including Grace Fellowship Church and YMCA of Metropolitan Milwaukee. The central hypothesis is that the cultural tailoring of HLWD will increase the reach, adoption, implementation, and effectiveness of HLWD among Black adults.
The study aims are:
- Co-design a culturally relevant approach to the recruitment and training of Black HLWD facilitators. The study team will partner with a stakeholder advisory board including:
- (1) Black adults with diabetes (prior HLWD participants)
- (2) Black community leaders
- (3) current Black HLWD facilitators, and
- (4) current HLWD program providers (organizational leaders in settings delivering HLWD to Black adults)
to co-design: (a) an asset-based approach to recruiting Black facilitators and (b) an adjunct training that empowers the facilitator to use a culturally relevant approach to deliver HLWD content to Black adults. 2. Implement the culturally tailored HLWD program among Black adults. Using a mixed methods design, the investigators will assess recruitment/retention rates among Black adults (reach), feasibility of adoption among facilitators and program providers (adoption), participant adherence, fidelity of enactment and acceptability, fidelity of program delivery by facilitators (implementation), and pre-post impact on diabetes outcomes (effectiveness).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
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
- •self-identify as Black/African American
- •have type 1 diabetes, type 2 diabetes, gestational diabetes, or pre-diabetes
排除标准
- 未提供
结局指标
主要结局
Recruitment: Number of Miles Participants are Willing to Travel for a Workshop
时间窗: up to 6 months
Retention: Proportion of Participants who Completed the HLWD Workshop and Final Assessments
时间窗: up to 6 months
Summary of Reasons for Declining to Participate Reported by Participant Count
时间窗: up to 6 months
Qualitative measure where reasons will be coded and grouped into themes for reporting.
Recruitment: Number of HLWD Participants Enrolled in a HLWD Workshop vs Invited to Enroll
时间窗: up to 6 months
Summary of Reasons for Agreeing to Participate Reported by Participant Count
时间窗: up to 6 months
Qualitative measure where reasons will be coded and grouped into themes for reporting.
Retention Rate during a 6-week Session
时间窗: Up to 6 weeks
Summary of Reasons for Dropping Out by Participant Count
时间窗: up to 6 months
Qualitative measure where reasons will be coded and grouped into themes for reporting.
次要结局
- Effectiveness: Diabetes Empowerment Scale - Short Form Self-Efficacy for Adherence to Medication Use Scale(Baseline, 6 weeks, 6 months)
- Implementation: Participant Satisfaction Ratings(up to 6 weeks)
- Facilitator Evaluation Reported in binary Yes / No(up to 6 months)
- Implementation: Summary of Diabetes Self-Care Activities (SDSCA)(up to 6 weeks)
- Effectiveness: Self-Reported Health Status(Baseline, 6 weeks, 6 months)
- Facilitator Adoption: Number Agreeing to be a Facilitator divided by the Number Approached(up to 6 months)
- Effectiveness: Patient's Perceived Involvement in Care Scale (PICS)(Baseline, 6 weeks, 6 months)
- Facilitator Feedback(up to 6 months)
- Implementation: Weekly Session Attendance(up to 6 weeks)