Clinical trial NCT03446768: Monitoring and Peer Support to Improve Treatment Adherence and Outcomes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Obstructive Sleep Apnea
Keywords: COPD
OSA
Lead sponsor: COPD Foundation
Sponsor class: OTHER
First posted: 2018-02-27
Enrollment: 294
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Change in CPAP Adherence at 6 Weeks
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in Daytime Functioning at 6 and12 Weeks
timeFrame: 6 weeks and 12 weeks
Other outcomes:
measure: Change in Sleep Quality at 6 and 12 Weeks
timeFrame: 6 weeks and 12 weeks
Locations:
city: Miami
country: United States
facility: COPD Foundation Inc.
state: Florida
Study officials:
affiliation: University of California, San Diego
name: Carl Stepnowsky, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: COPD Foundation
name: Elisha Malanga, BS
role: PRINCIPAL_INVESTIGATOR
References: