MoVE Trial: Motivational Strategies To Empower African Americans To Improve Dialysis Adherence
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 176
- 试验地点
- 11
- 主要终点
- Dialysis treatment adherence
研究概览
简要总结
MoVE Trial is a randomized clinical trial designed to rigorously test the impact of a behavioral intervention (culturally tailored motivational interviewing - (MOVE)) delivered by trained health coaches, on hemodialysis treatment non-adherence. It is a a two-arm, parallel group randomized clinical trial with 24-week follow-up. It involves completion of surveys by patients enrolled in the study. It also involves participation in motivational interviewing sessions by patients who are randomized to the intervention (MI).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •Receiving hemodialysis treatments
- •Been on hemodialysis for more than 30 days
- •18 years of age and older
- •Within a 2-month look back at the time of screening, patients who have missed at least one dialysis session or shortened at least one dialysis session by 15 minutes.
排除标准
- •Not self-identified as African American
- •Impaired with mental status or severe illness
- •Non-English speaking
- •No documented evidence of dialysis treatment non-adherence
- •Missed or shortened treatments due to hospitalizations or excused travel
- •Terminal condition
- •Living in a nursing home/rehab
- •Planned transplant within the next 6 months
- •Planned conversion to peritoneal dialysis within the next 6 months
研究组 & 干预措施
Standard of Care
Standard of Care
Participants receiving intervention
Motivational interviewing intervention
干预措施: Motivational interviewing (Behavioral)
结局指标
主要结局
Dialysis treatment adherence
时间窗: Baseline to 24 weeks post-intervention
Abstraction of dialysis treatment adherence data from the dialysis units' records which includes data on every treatment that occurred or should have occurred within the time frame. Records will reflect dialysis treatments which were completed, shortened, missed or did not occur due to hospitalizations, ER visits or travel.
次要结局
- Change in Autonomy Support(Baseline, Week 8, Week 24)
- Change in Autonomous Regulation(Baseline, Week 8, Week 24)
- Change in Perceived competence(Baseline, Week 8, Week 24)
- Change in Optimism(Baseline, Week 8, Week 24)
- Change in Apathy(Baseline, Week 8, Week 24)
研究者
Ebele Umeukeje
Associate Professor of Medicine
Vanderbilt University Medical Center