Improving Obstructive Sleep Apnea Management Via Wireless Telemonitoring
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Nightly CPAP Adherence
研究概览
简要总结
Obstructive sleep apnea (OSA) is a major chronic condition affecting the quality of life of up to one-fifth of all Veterans. Because of disappointingly low adherence to the gold-standard treatment (continuous positive airway pressure therapy - CPAP), the Institute of Medicine has stated that new adherence strategies are needed that improve the quality of care, reduce social and economic costs, and help OSA patients live happier, healthier, and more productive lives through improved clinical management. The combination of a self-management approach along with emerging wireless technologies has strong potential to increase treatment adherence and improve outcomes.
详细描述
The Sleep Apnea Self-Management Program (SASMP) was evaluated by conducting a randomized, controlled trial of the program compared to Usual Care in patients diagnosed with OSA and prescribed CPAP therapy. Participants randomized to the SASMP group attended 4 weekly educational sessions of approximately two hours each. A trained leader facilitated the program from a scripted manual. Key topics covered in this program included: (1) management of OSA symptoms, CPAP side effects, and weight loss; (2) maintaining social contacts and family relationships; and (3) dealing with symptoms of depression and worries about the future.
The primary aim of this study was to examine the effect of the SASMP, compared to Usual Care, on CPAP adherence. It is hypothesized that SASMP participants will have higher levels of CPAP adherence compared to those in the Usual Care group.
A second aim of the study was to examine the effect of the SASMP, compared to Usual Care, on proposed mediating variables derived from social cognitive theory (perceived self-efficacy, outcome expectations). It is hypothesized that SASMP participants would have higher levels of self-efficacy and outcome expectations compared to the Usual Care group.
And the third aim of the study was to measure the short- and long-term effects of the SASMP, compared to Usual Care, on health outcomes (e.g., OSA symptoms and OSA-specific HRQOL). It is hypothesized that improvements in OSA symptoms and OSA-specific HRQOL will be seen both initially and as maintained 6 months and 1 year after the start of the SASMP.
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 (Care Provider)
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
- •Diagnosis of OSA
- •Prescription for CPAP treatment by a sleep physician
- •Being CPAP naïve (ie, no previous use of CPAP).
排除标准
- •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
研究组 & 干预措施
Self-Management (SM)
Active Intervention - Self-management: Self-management Educational component focused on sleep apnea and CPAP from a self-management perspective
干预措施: Self-management (Behavioral)
Telemonitored Care (TC)
Active Comparator - Telemonitored care: Telemonitored care Consists of CPAP therapist actively monitoring care at a distance, and acting on that data per a set protocol
干预措施: Telemonitored care (Behavioral)
SM + TC
Self-management and Telemonitored care: Combination of both SM + TC intervention
干预措施: Self-management (Behavioral)
SM + TC
Self-management and Telemonitored care: Combination of both SM + TC intervention
干预措施: Telemonitored care (Behavioral)
Usual care (UC)
Control Group
结局指标
主要结局
Nightly CPAP Adherence
时间窗: 3 mos
Nightly CPAP adherence hours per night measured over the three-months period
次要结局
未报告次要终点