Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score
研究概览
简要总结
The study is to maximize efficacy of message delivery to achieve desired Obstructive sleep apnea (OSA) adherence goal. Newly diagnosed black patients (n=390, all genders) from participating sleep clinics will be randomly exposed to either the individually tailored or standard OSA messages. Investigators will look at an effective and scalable intervention to improve OSA-related outcomes: a) clinical CVD and brain health measures and b) patient-centered outcomes. Patient-centered and adherence data will be captured via REDCap, enabling real-time application of data-driven decision rules while implementing the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
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-reported race/ethnicity as African American, African, Caribbean or black
- •Accessible by phone
- •No plans to move away within the year
- •OSA diagnosis, consent, including permission to release medical data
- •Physician-diagnosed medical conditions.
排除标准
- •Progressive illnesses in which disability or death is expected within 1 year
- •Impaired cognitive/ functional ability precluding participation
- •Intention to move within the same year of enrollment
- •Family member currently enrolled
结局指标
主要结局
Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score
时间窗: 2 Months and 6 Months
The mean of the nonmissing item responses was calculated for each of the 3 subscales: Perceived Risk, Outcome Expectancies, and Treatment Self-Efficacy. Using this mean-weighted score prevents the distortion of the score from missing responses. Factor 1 (Risk Perception consisting of 8 questions); Factor 2 (Outcome Expectancy consisting of 9 items) and Factor 3 (Treatment Self Efficacy consisting of 9 items) are given a potential score of 1-4.
次要结局
未报告次要终点