Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- CPAP Adherence
研究概览
简要总结
The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.
详细描述
Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the "amount of time CPAP is used at the prescribed pressure." This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •age > 18 years
- •confirmed diagnosis of OSA
- •being newly prescribed CPAP therapy
- •having chronic symptoms as noted on screening symptom checklist
- •fluency in English
排除标准
- •cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30)
- •residence in a geographical area outside of San Diego County
- •fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
- •significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment
结局指标
主要结局
CPAP Adherence
时间窗: 4 months
次要结局
- Quality of patient-centered collaborative care(4 months)
研究者
Carl J. Stepnowsky
Study PI
Veterans Medical Research Foundation
