OurSleepKit: A Couple-focused m-Health Intervention to Support Adherence to CPAP Treatment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 360
- 试验地点
- 2
- 主要终点
- CPAP adherence
研究概览
简要总结
The goal of this clinical trial is to learn if a couple-focused mobile health intervention will improve the use of continuous positive airway pressure (CPAP), the primary treatment option for obstructive sleep apnea (OSA). Participants include newly diagnosed patients with OSA who are candidates for CPAP treatment and their partners. The couples will received supportive information and resources on their mobile devices before CPAP begins and continuing for 6 months into CPAP treatment. Their interaction with the resources is self-paced and the time sent engaging with the information is up to them. Participants will be asked to answer questions independently at five points: before CPAP, and after using CPAP for 1-week, 1-month, 3-months and 6-months. Those questions are about their experience of using CPAP, how the partner is involved in CPAP treatment, and symptoms and quality of life. At the end of the study, some couples may be contacted for a virtual discussion about your experience regarding study participation which lasts approximately 1 hour.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, 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
- •patients should be males or females (age≥18 years) with diagnosed OSA and candidates for CPAP therapy (with any type of pressure delivery mode), and are cohabiting with their partner for at least one year
- •The partners of eligible patients will be recruited if they are not diagnosed with OSA and not using CPAP
- •both partners should have their own mobile devices with access to the internet
排除标准
- •have a diagnosis of a sleep disorder other than OSA based on a polysomnogram (e.g., central sleep apnea, narcolepsy, or periodic limb movement disorder)
- •have planned bariatric surgery (as they typically quit CPAP after surgery)
- •have a partner using CPAP
- •are pregnant because the changes in respiration and sleep quality occurring with pregnancy may confound the results.
- •couples with one or both partners doing regular overnight shift work or those unable to speak or write in English will be excluded.
研究组 & 干预措施
Intervention group
Couples in the intervention group will have exposure to the OurSleepKit app in addition to usual care.
Control group
Couples in the control group will not have exposure to the OurSleepKit app during the trial. Patients will receive usual care.
结局指标
主要结局
CPAP adherence
时间窗: 6 months
Average hours of nightly CPAP use over the course of the first six months of treatment
次要结局
- Self-efficacy(6 months)
- Functional Status(6 months)
- Dyadic Coping(6 months)
- Daytime Sleepiness(6 months)
- Sleep Quality and Sleep-related Impairment(6 months)
- Partner Involvement in CPAP Treatment(6 months)
- Health-Related Quality of life(6 months)