Results Summary

What was the research about?

Chronic obstructive pulmonary disease, or COPD, and obstructive sleep apnea are long-term health problems that make it hard to breathe and limit oxygen to the body. Having both COPD and sleep apnea is called overlap syndrome. People with overlap syndrome can use continuous positive airway pressure, or CPAP, to help them breathe while sleeping. CPAP therapy uses mild air pressure to keep airways open.

In this study, the research team compared two ways to help patients use CPAP therapy:

  • Proactive care. Patients completed an online course about COPD, sleep apnea, and CPAP. A peer coach, a person with COPD, called patients weekly for five weeks to answer questions about living with overlap syndrome. In the fifth week, a respiratory therapist called patients to answer final questions.
  • Reactive care. Patients could access a website with information about COPD and sleep apnea. Patients could also call a COPD information line answered by peer coaches.

The research team wanted to compare how well the two types of care improved patients’ use of CPAP and their sleep outcomes.

What were the results?

CPAP use did not increase for patients in either group compared with their CPAP use at the start of the study. Also, patients’ sleep quality, daytime sleepiness, and ability to do daily activities did not improve in either group.

Who was in the study?

The study included 294 people with overlap syndrome from across the United States. Among patients, 88 percent were White, 5 percent were Black, and 6 percent reported other race or multiple races; 4 percent were Hispanic. The average age was 64, and 53 percent were men.

What did the research team do?

The research team used email, social media, and outreach through COPD and sleep apnea websites and PCORnet® to recruit patients. PCORnet is a national network of health systems created to conduct research funded by PCORI. The team assigned patients by chance to receive proactive or reactive care for five weeks. A respiratory therapist called patients in both groups to help them set goals for CPAP use.

CPAP companies helped patients and researchers have access to data on patients’ use of CPAP.

At the start of the study and 6 and 12 weeks later, patients completed online or phone surveys. The research team collected data about patients’ CPAP use for one month before the study and during the study. Patients with overlap syndrome helped plan the study and select study outcomes.

What were the limits of the study?

Patients who took part in this study were already using CPAP more than six hours per night on average. The unexpected high use of CPAP made it hard for the study to further improve CPAP use.

Future research could include patients with low CPAP use.

How can people use the results?

Researchers can use the results when planning other studies to improve CPAP use for patients with overlap syndrome.

How this project fits under PCORI’s Research Priorities
The COPD Patient-Powered Research Network (COPD PPRN) formerly was a Network Partner in PCORnet®, the National Patient-Centered Clinical Research Network. PCORnet® has been developed with funding from the Patient-Centered Outcomes Research Institute (PCORI).

Final Research Report

View this project's final research report.

Peer-Review Summary

Peer review of PCORI-funded research helps make sure the report presents complete, balanced, and useful information about the research. It also assesses how the project addressed PCORI’s Methodology Standards. During peer review, experts read a draft report of the research and provide comments about the report. These experts may include a scientist focused on the research topic, a specialist in research methods, a patient or caregiver, and a healthcare professional. These reviewers cannot have conflicts of interest with the study.

The peer reviewers point out where the draft report may need revision. For example, they may suggest ways to improve descriptions of the conduct of the study or to clarify the connection between results and conclusions. Sometimes, awardees revise their draft reports twice or more to address all of the reviewers’ comments. 

Peer reviewers commented and the researchers made changes or provided responses. Those comments and responses included the following:

  • Reviewers noted that there were baseline differences in patient use of a continuous positive airway pressure (CPAP) device between the two intervention groups, Proactive Care and Reactive Care. Reviewers were concerned that this imbalance indicated that randomization of patients to intervention groups did not work as intended and asked the researchers to speculate on the reasons for this imbalance. The researchers responded that there was no clear reason for this discrepancy in CPAP use, but it might have been related to their finding that a subgroup of CPAP users used the device both at night and during the day, and more of these individuals may have been randomly assigned to the Reactive Care group. The researchers did point out that there were no other significant differences between the two groups at baseline.
  • Reviewers asked why the report did not describe the first two projects of the study: (1) convening focus groups to learn about the patient community, and (2) patient and stakeholder engagement activities. The researchers explained that there was not enough room in the report to describe those projects in detail, so the report focused on the comparative effectiveness question. However, the focus group work is provided as a draft manuscript in the report Appendix.
  • The reviewers considered the possible reasons that there were no group differences in CPAP use between the two treatment groups, noting that the Reactive Care group had access to more information about CPAP use and the related chronic illnesses than might normally be available to patients using CPAP. The researchers agreed, reiterating their surprise about the high baseline CPAP adherence rates they identified when most studies found a partial CPAP use pattern. They added a comment in the report’s Discussion section that their study differed from other studies, because other studies typically compared the active intervention with an inactive intervention, whereas this study included a comparison intervention, Reactive Care, that could also be considered active.

Conflict of Interest Disclosures

Project Information

Carl Stepnowsky, PhD^
COPD Foundation, Inc.
$2,535,043
10.25302/09.2021.PPRND.150731666
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 (O2VERLAP)

Key Dates

March 2016
October 2021
2016
2021

Study Registration Information

^David M. Mannino, MD, was the original principal investigator for this project.

Tags

Has Results
Health Conditions Health Conditions These are the broad terms we use to categorize our funded research studies; specific diseases or conditions are included within the appropriate larger category. Note: not all of our funded projects focus on a single disease or condition; some touch on multiple diseases or conditions, research methods, or broader health system interventions. Such projects won’t be listed by a primary disease/condition and so won’t appear if you use this filter tool to find them. View Glossary
Intervention Strategy Intervention Strategies PCORI funds comparative clinical effectiveness research (CER) studies that compare two or more options or approaches to health care, or that compare different ways of delivering or receiving care. View Glossary
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Last updated: November 30, 2022