Monitoring and Peer Support to Improve Treatment Adherence and Outcomes

NCT03446768 | Completed Results

• 1 other identifier: 20173014
• Study Type: interventional
• Target: 294
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease; Obstructive Sleep Apnea

Keywords

COPD; OSA

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Daytime Functioning at 6 and12 Weeks

  6 weeks and 12 weeks

Other Outcomes (1)

• Change in Sleep Quality at 6 and 12 Weeks

  6 weeks and 12 weeks

Study Arms (2)

Reactive Care (RC)

ACTIVE COMPARATOR

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

Proactive Care (PC)

ACTIVE COMPARATOR

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

Interventions

Peer support OTHER

Access to educational and informational support by a trained peer coach

Proactive Care (PC); Reactive Care (RC)

Online platform OTHER

An online platform that provides educational, informational and access to several therapeutic device metrics

Proactive Care (PC)

Respiratory Therapist support OTHER

Limited medical support provided by trained Respiratory Therapists.

Proactive Care (PC)

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• COPD Foundation: lead

Study Sites (1)

COPD Foundation Inc.

Miami, Florida, 33134, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Apnea Syndromes; Apnea; Respiration Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Limitations and Caveats

The study utilized a national, electronic only recruitment method, which was primarily focused on the chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA) communities. This may have resulted in a sample of participants who are more actively involved online seeking information and support for their medical condition. Future studies would benefit from recruiting a more diverse sample of patients on a number of dimensions.

Results Point of Contact

• Title: Carl Stepnowsky, PhD
• Organization: University of California, San Diego, La Jolla, CA

cstepnowsky@health.ucsd.edu

858-642-1240

Study Officials

• Carl Stepnowsky, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

• Elisha Malanga, BS

  COPD Foundation

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2018
• First Posted: February 27, 2018
• Study Start: February 1, 2018
• Primary Completion: October 31, 2019
• Study Completion: October 31, 2019
• Last Updated: December 3, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-10

Locations

US (1)