BIG4 - CPAP Educational Materials and Usage Feedback to Promote CPAP Adherence
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 6
- 主要终点
- Adherence
研究概览
简要总结
The study hypothesis: in groups receiving tailored education and feedback in a style that matches their psychological profile, will show a higher CPAP adherence rates than groups receiving mismatched tailored education / feedback, and groups that receive no tailored education and feedback (standard of care).
详细描述
Three group, randomized, controlled clinical trial assessing the extent to which tailoring a CPAP intervention entailing education and feedback to the psychological profile of new CPAP users can enhance the impact of the intervention in terms of adherence-related behavior.
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
- Single (Participant)
入排标准
- 年龄范围
- 21 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females, ages 21-80 years
- •Prescribed to start CPAP treatment and diagnosed with mild to severe OSA.
- •Recently (within study period) diagnosed with Mild to Severe OSA defined as an Apnea-Hypopnea Index of equal to or greater than 10 events per hour of sleep.
- •CPAP treatment naïve
排除标准
- •Inability to provide informed consent
- •Presence of a comorbid condition that may potentially complicate CPAP adherence, such as:
- •Unstable depressive disorder
- •Unstable anxiety disorder
- •Unable to understand study information
- •Obesity Hypoventilation Syndrome
- •Central Sleep Apnea or Complex Sleep Apnea
- •Facial musculoskeletal disorder
- •Unwillingness or inability to use CPAP therapy
- •Unable to return for follow up appointment
- •Use of supplemental oxygen
研究组 & 干预措施
Treatment
Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
干预措施: Education and feedback (Behavioral)
Control Group
Participants will receive education inconsistent with their profile.
干预措施: Education and feedback (Behavioral)
Standard of care
Participants will not receive education or feedback.
结局指标
主要结局
Adherence
时间窗: 3 months
Average usage days per week.
Nightly Adherence
时间窗: 3 months
Average usage hours per night
次要结局
- Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale(3 months)
- Participant's Feedback on Educational Pamphlets - Motiviation(3 months)
- Participant's Feedback on Educational Pamphlets - Leaflet Assessment(2 months)
- Participant's Feedback on Educational Pamphlets - Importance Scale(3 months)
- Participant's Feedback on Educational Pamphlets - Expectations Scale(3 months)