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). |
Professional Abstract
Objective
To compare the effectiveness of proactive versus reactive care on improving adherence with continuous positive airway pressure (CPAP) therapy among patients with chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea
Study Design
| Design Element | Description |
|---|---|
| Design | Randomized controlled trial |
| Population | 294 people ages 40 and older who were diagnosed with COPD and obstructive sleep apnea and prescribed CPAP therapy |
| Interventions/ Comparators |
|
| Outcomes |
Primary: CPAP adherence Secondary: daytime functioning, sleep quality, and daytime sleepiness |
| Timeframe | 6-week follow-up for primary outcome |
This randomized controlled trial compared proactive versus reactive care strategies for improving CPAP adherence and patient-reported outcomes among patients with a diagnosis of both COPD and obstructive sleep apnea, commonly referred to as overlap syndrome.
Researchers recruited patients through PCORnet®, the National Patient-Centered Clinical Research Network, and COPD and obstructive sleep apnea patient organizations. They used email, social media posts, and other online forums to direct patients to the study website.
Researchers randomly assigned patients to receive proactive or reactive care for five weeks. In proactive care, patients received access to an online forum and educational course about COPD, sleep apnea, and CPAP use and equipment. Each week for five weeks, peer coaches called patients to answer questions and offer support for living with overlap syndrome. Peer coaches were people with COPD or caregivers of a patient with COPD. In week five, a respiratory therapist called patients who had completed the educational course to answer any remaining questions.
In reactive care, patients had access to a website with information about COPD and sleep apnea. Researchers gave patients a phone number, which they could call to speak to a peer coach for advice about overlap syndrome and CPAP therapy.
At the start of the study, a respiratory therapist called enrolled patients to help them set goals to improve CPAP adherence. All patients had access to their daily CPAP adherence data through a patient portal.
The study included 294 people with overlap syndrome from across the United States. Among patients, 88% were White, 5% were Black, and 6% reported multiple races or other race; 4% were Hispanic. The average age was 64, and 53% were male.
Patients completed surveys electronically or by phone at baseline and again 6 and 12 weeks later. Working with CPAP manufacturers, researchers collected CPAP adherence data from the patients’ CPAP machines for the one month prior to randomization, then daily throughout the three-month study.
People with overlap syndrome identified outcomes that mattered to them and helped plan the study.
Results
The two groups did not differ significantly in changes in patients’ CPAP adherence, sleep quality, sleepiness level, or daytime functioning from baseline to either the 6-week or 12-week follow up.
Limitations
The study found an unexpectedly high baseline CPAP adherence level of six hours a night, which meant that any improvement due to the intervention would have been small and difficult to detect.
Conclusions and Relevance
In this study, compared with reactive care strategies, proactive care strategies did not improve CPAP adherence or patient-reported outcomes for patients with overlap syndrome.
Future Research Needs
Future research could compare proactive and reactive care strategies among patients with low CPAP adherence.
| 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.
Journal Citations
Results of This Project
Related Journal Citations
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
Key Dates
Study Registration Information
^David M. Mannino, MD, was the original principal investigator for this project.