Trial Outcomes & Findings for Monitoring and Peer Support to Improve Treatment Adherence and Outcomes (NCT NCT03446768)

Last Updated: 2021-12-03

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

294 participants

Primary outcome timeframe

6 weeks

Results posted on

2021-12-03

Participant Flow

Participant milestones

Participant milestones
Measure	Reactive Care (RC) 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. Peer support: Access to educational and informational support by a trained peer coach	Proactive Care (PC) 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. 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.
Overall Study STARTED	141	153
Overall Study COMPLETED	141	152
Overall Study NOT COMPLETED	0	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Reactive Care (RC) 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. Peer support: Access to educational and informational support by a trained peer coach	Proactive Care (PC) 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. 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.
Overall Study Withdrawal by Subject	0	1

Baseline Characteristics

Monitoring and Peer Support to Improve Treatment Adherence and Outcomes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Reactive Care (RC) n=141 Participants 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. Peer support: Access to educational and informational support by a trained peer coach	Proactive Care (PC) n=153 Participants 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. 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.	Total n=294 Participants Total of all reporting groups
Age, Continuous	64.7 years n=5 Participants	64.2 years n=7 Participants	64.4 years n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants	68 Participants n=7 Participants	139 Participants n=5 Participants
Sex: Female, Male Male	70 Participants n=5 Participants	85 Participants n=7 Participants	155 Participants n=5 Participants
Race/Ethnicity, Customized Race · White	128 Participants n=5 Participants	132 Participants n=7 Participants	260 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black or African American	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Race/Ethnicity, Customized Race · Multiple Race	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Race · Other	0 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	141 participants n=5 Participants	153 participants n=7 Participants	294 participants n=5 Participants

PRIMARY outcome

Timeframe: 6 weeks

Outcome measures

Outcome measures
Measure	Reactive Care (RC) n=141 Participants 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. Peer support: Access to educational and informational support by a trained peer coach	Proactive Care (PC) n=153 Participants 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. 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.
Change in CPAP Adherence at 6 Weeks	7.4 hours per night of CPAP use Standard Deviation 2.2	6.3 hours per night of CPAP use Standard Deviation 2.7

SECONDARY outcome

Timeframe: 6 weeks and 12 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.

Outcome measures

Outcome measures
Measure	Reactive Care (RC) n=141 Participants 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. Peer support: Access to educational and informational support by a trained peer coach	Proactive Care (PC) n=153 Participants 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. 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.
Change in Daytime Functioning at 6 and12 Weeks 6 weeks	15.2 score on a scale Standard Deviation 3.0	14.6 score on a scale Standard Deviation 3.7
Change in Daytime Functioning at 6 and12 Weeks 12 weeks	15.1 score on a scale Standard Deviation 3.2	14.6 score on a scale Standard Deviation 3.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 6 weeks 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.

Outcome measures

Outcome measures
Measure	Reactive Care (RC) n=141 Participants 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. Peer support: Access to educational and informational support by a trained peer coach	Proactive Care (PC) n=153 Participants 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. 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.
Change in Sleep Quality at 6 and 12 Weeks 6 weeks	7.9 score on a scale Standard Deviation 4.1	8.8 score on a scale Standard Deviation 4.1
Change in Sleep Quality at 6 and 12 Weeks 12 weeks	7.6 score on a scale Standard Deviation 4.0	8.4 score on a scale Standard Deviation 4.1

Adverse Events

Reactive Care (RC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Proactive Care (PC)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carl Stepnowsky, PhD

University of California, San Diego, La Jolla, CA

Phone: 858-642-1240

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place