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临床试验/NCT03446768
NCT03446768已完成不适用

Monitoring and Peer Support to Improve Treatment Adherence and Outcomes in Patients With Overlap Chronic Obstructive Pulmonary Disease and Sleep Apnea Via a Large PCORnet Collaboration

COPD Foundation2 个研究点 分布在 1 个国家目标入组 294 人开始时间: 2018年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
294
试验地点
2
主要终点
Change in CPAP Adherence at 6 Weeks

研究概览

简要总结

The O2VERLAP study investigators would like to find out if individuals living with both COPD and OSA would benefit from an online, educational curriculum, coupled with access to peer support (i.e. telephone and online chatting with peers) and remote CPAP adherence monitoring data. The curriculum and peer coaching is meant to provide participants the information and tools they need to be more compliant in using their CPAP device.

详细描述

The O2VERLAP study focuses on a subset of the Chronic Obstructive Pulmonary Disease (i.e. COPD) community that are also living with a diagnosis of Sleep Apnea (i.e. SA); having a diagnosis of both COPD and SA is referred to as Overlap Syndrome (i.e. OS). There are about 300 million people living with COPD globally; of those, OSA affects 17% of adults and over 25% of older adults with rates increasing in association with the obesity epidemic. So, there are approximately 51-75 million individuals living with OS worldwide. This subset of the COPD community is met with increased morbidity and mortality rates compared to either diagnosis alone. The primary treatment for OSA is continuous positive airway pressure (i.e. CPAP, sometimes shortened to PAP).

When individuals with OS are adherent to their nighttime CPAP therapies they see significantly improved outcomes, comparable to individuals living with a diagnosis of COPD alone. As a result, the primary aim of this study is to improve CPAP adherence in patients living with OS. The study investigators hope to do this through a proactive, peer-support based intervention, supplemented by an online curriculum and access to remote CPAP adherence monitoring data. Peer-coaches will include individuals who are living with COPD and OSA, who are similar to the study population. The COPD Information Line associates will act in this peer- support role through dyadic, telephone-based communication and through secure online chat. The COPD Information Line peer-coaches will be able to provide participants experience- based advice, patient-centered guidance on troubleshooting adherence barriers, as well as patient-centered advice on how to facilitate CPAP adherence. Peer coaches will also include Respiratory Therapists who will be able to provide coaching from the perspective of a caregiver. Additionally, all peer based support aims to provide emotional and social support to participants. The participants will have the ability to chat with their peer coaches online, both in real-time and asynchronously, and will additionally have weekly check ins with their coaches. The curriculum addresses many common CPAP adherence barriers and facilitators. The investigators hope that the combination of peer-support and self-learning will cultivate patient activation, self-management strategies and improve participant's health literacy. Ultimately, the investigators expect that this will improve CPAP adherence rates at 6 weeks and 12 weeks.

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
Single (Participant)

入排标准

年龄范围
40 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age: >40 years
  • Primary language: English
  • Diagnosed with both Chronic Obstructive Pulmonary Disease (COPD) and Obstructive Sleep Apnea (OSA)
  • Prescription for positive airway pressure therapy (PAP). There should be no minimum or maximum flow required (i.e., no limitation on PAP modality).
  • Access to the internet viand a PC, tablet, or smart phone to complete all study activities from home or remotely
  • PAP device with wireless modem

排除标准

  • Non-English speakers
  • Life expectancy less than or equal to six months

结局指标

主要结局

Change in CPAP Adherence at 6 Weeks

时间窗: 6 weeks

CPAP adherence is being measured through remote adherence monitoring of all participants; the study inclusion criteria requires all participants be using a CPAP device with wireless modem, the wireless modem allows the study investigators to accurately measure participants CPAP usage daily. Participants CPAP device record the 'total time connected' each day or total time the device is being used (i.e. units are hours per day). Study investigators will retroactively access and collect 30-days of baseline adherence data, prior to randomization, to measure the participants level of baseline adherence. The study investigators will then track participants total time using their CPAP device in hours, each day, for the duration of the participants enrollment (i.e. about three months).

次要结局

  • Change in Daytime Functioning at 6 and12 Weeks(6 weeks and 12 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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