Monitoring and Peer Support to Improve Treatment Adherence and Outcomes

Chronic Obstructive Pulmonary Disease Clinical Trial

— O2VERLAP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03446768
• Other study ID #: 20173014
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: October 31, 2019

Study information

• Verified date: October 2021
• Source: COPD Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 294
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Sleep Apnea
• Pulmonary Disease, Chronic Obstructive
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• Peer support
Access to educational and informational support by a trained peer coach
• Online platform
An online platform that provides educational, informational and access to several therapeutic device metrics
• Respiratory Therapist support
Limited medical support provided by trained Respiratory Therapists.

Locations

Country	Name	City	State
United States	COPD Foundation Inc.	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
COPD Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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.	6 weeks and 12 weeks
Primary	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).	6 weeks
Secondary	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.	6 weeks and 12 weeks