An interventional study of Peer support and Online platform in Chronic Obstructive Pulmonary Disease and Obstructive Sleep Apnea, sponsored by COPD Foundation. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-12-03.
Sponsored by COPD Foundation · Not applicable, Interventional, and Supportive care
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.
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's enrollment of 294 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →COPD Foundation is the lead sponsor of 6 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants in the RC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support.
Other: Peer support
Participants in the PC arm of the study will be provided access to the COPD Information Line if they feel they would benefit from the support of a peer health coach. Peer health coaches working the information line are patients also living with COPD who can offer peer level support. Additionally, the PC group will also receive access to an online study portal which houses an educational health curriculum covering topics related to COPD and OSA. The portal allows participants to send online messages to peer coaches and respiratory therapist coaches. PC group will also receive weekly updates.
Other: Peer support · Other: Online platform · Other: Respiratory Therapist support
Access to educational and informational support by a trained peer coach
An online platform that provides educational, informational and access to several therapeutic device metrics
Limited medical support provided by trained Respiratory Therapists.
Change in CPAP Adherence at 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).
Time frame: 6 weeks
Change in Daytime Functioning at 6 and12 Weeks
Change in daytime functioning will be measured using the Functional Outcomes of Sleep Quality (FOSQ) questionnaire. The FOSQ measures impact of sleepiness on activities of daily living (ADLs). The FOSQ-10 consists of 10 questions on a scale of 1 to 4 (1 = extreme difficulty, 4 = no difficulty). A lower score indicates more difficulty with ADLs due to lack of sleep. The FOSQ total score is the mean of subscale scores (ie, vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. The scores range from 5 (maximum difficulty) to 20 (no difficulty). Change in FOSQ total score is calculated from baseline to end point, with higher (positive) values representing improvement. The worst possible change value would be -15 and the best would be +15.
Time frame: 6 weeks and 12 weeks
Change in Sleep Quality at 6 and 12 Weeks
Change in sleep quality at 6 weeks and 12 weeks will be larger in the proactive care group compared to the reactive care group. This will be measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated, 19-item questionnaire used to assess sleep quality and disturbances over the previous 1 month. Items are scored on a Likert scale, with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. PSQI scores can range from 0 to 21, with higher scores indicating worse sleep quality.
Time frame: 6 weeks and 12 weeks
| Milestone | Reactive Care (RC) | Proactive Care (PC) |
|---|---|---|
| Started | 141 | 153 |
| Completed | 141 | 152 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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).
| hours per night of CPAP use | Reactive Care (RC) | Proactive Care (PC) |
|---|---|---|
| Change in CPAP Adherence at 6 Weeks | 7.4 ± 2.2 | 6.3 ± 2.7 |
Change in daytime functioning will be measured using the Functional Outcomes of Sleep Quality (FOSQ) questionnaire. The FOSQ measures impact of sleepiness on activities of daily living (ADLs). The FOSQ-10 consists of 10 questions on a scale of 1 to 4 (1 = extreme difficulty, 4 = no difficulty). A lower score indicates more difficulty with ADLs due to lack of sleep. The FOSQ total score is the mean of subscale scores (ie, vigilance, productivity, social outcome, intimacy, activity) multiplied by 5. The scores range from 5 (maximum difficulty) to 20 (no difficulty). Change in FOSQ total score is calculated from baseline to end point, with higher (positive) values representing improvement. The worst possible change value would be -15 and the best would be +15.
| score on a scale | Reactive Care (RC) | Proactive Care (PC) |
|---|---|---|
| 6 weeks | 15.2 ± 3.0 | 14.6 ± 3.7 |
| 12 weeks | 15.1 ± 3.2 | 14.6 ± 3.6 |
Change in sleep quality at 6 weeks and 12 weeks will be larger in the proactive care group compared to the reactive care group. This will be measured using the Pittsburgh Sleep Quality Index (PSQI). The PSQI is a self-rated, 19-item questionnaire used to assess sleep quality and disturbances over the previous 1 month. Items are scored on a Likert scale, with 0 being indicative of better sleep and the maximum value of 3 being indicative of poor sleep. PSQI scores can range from 0 to 21, with higher scores indicating worse sleep quality.
| score on a scale | Reactive Care (RC) | Proactive Care (PC) |
|---|---|---|
| 6 weeks | 7.9 ± 4.1 | 8.8 ± 4.1 |
| 12 weeks | 7.6 ± 4.0 | 8.4 ± 4.1 |
Collected over 12 weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Reactive Care (RC) | 0/141 (0%) | 0/141 (0%) | 0/141 (0%) |
| Proactive Care (PC) | 0/153 (0%) | 0/153 (0%) | 0/153 (0%) |
| Age, Continuous(years) | Reactive Care (RC) | Proactive Care (PC) | Total |
|---|---|---|---|
| Mean | 64.7 (45 to 86) | 64.2 (41 to 89) | 64.4 (41 to 89) |
| Sex: Female, Male(Participants) | Reactive Care (RC) | Proactive Care (PC) | Total |
|---|---|---|---|
| Female | 71 | 68 | 139 |
| Male | 70 | 85 | 155 |
| Race/Ethnicity, Customized(Participants) | Reactive Care (RC) | Proactive Care (PC) | Total |
|---|---|---|---|
| Race — White | 128 | 132 | 260 |
| Race — Black or African American | 6 | 10 | 16 |
| Race — Multiple Race | 6 | 7 | 13 |
| Race — Asian | 1 | 0 | 1 |
| Race — Other | 0 | 4 | 4 |
| Region of Enrollment(participants) | Reactive Care (RC) | Proactive Care (PC) | Total |
|---|---|---|---|
| United States | 141 | 153 | 294 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Feb 2018 to primary completion in Oct 2019, 20 months.
Results were first posted in Dec 2021, 2 years 1 month after primary completion.
Of 1,094 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 20 months is close to that.
Counting every sponsor, half of 1,181 studies reached it within 22 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.
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