CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence

Not Applicable

Completed

• Conditions: Adherence
• Interventions: Behavioral: Education and feedback

• Registration Number: NCT02195531
• Lead Sponsor: Philips Respironics

Brief Summary

The study hypothesis: in groups receiving tailored education and feedback in a style that matches their psychological profile, will show a higher CPAP adherence rates than groups receiving mismatched tailored education / feedback, and groups that receive no tailored education and feedback (standard of care).

Detailed Description

Three group, randomized, controlled clinical trial assessing the extent to which tailoring a CPAP intervention entailing education and feedback to the psychological profile of new CPAP users can enhance the impact of the intervention in terms of adherence-related behavior.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-07-14
• Study First Submitted QC: 2014-07-16
• Study First Posted: 2014-07-21
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Results First Submitted: 2018-06-22
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-08
• Last Update Submitted: 2019-01-08
• Results First Posted: 2019-04-05
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• Males or females, ages 21-80 years
• Prescribed to start CPAP treatment and diagnosed with mild to severe OSA.
• Recently (within study period) diagnosed with Mild to Severe OSA defined as an Apnea-Hypopnea Index of equal to or greater than 10 events per hour of sleep.
• CPAP treatment naïve

Exclusion Criteria

• Inability to provide informed consent

• Presence of a comorbid condition that may potentially complicate CPAP adherence, such as:

  • Unstable depressive disorder

  • Unstable anxiety disorder

  • Dementia

  • Unable to understand study information

  • Obesity Hypoventilation Syndrome

  • Central Sleep Apnea or Complex Sleep Apnea

  • Facial musculoskeletal disorder

    • Unwillingness or inability to use CPAP therapy
    • Unable to return for follow up appointment
    • Use of supplemental oxygen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Education and feedback	Participants will receive education and feedback tailored to the psychological profile of the receiving participant.
Control Group	Education and feedback	Participants will receive education inconsistent with their profile.

Primary Outcome Measures

Name	Time	Method
Adherence	3 months	Average usage days per week.
Nightly Adherence	3 months	Average usage hours per night

Secondary Outcome Measures

Name	Time	Method
Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale	3 months	Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.; Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree.; The average of each question was analyzed.
Participant's Feedback on Educational Pamphlets - Motiviation	3 months	Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.; Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much.; The average of the questions were analyzed.
Participant's Feedback on Educational Pamphlets - Leaflet Assessment	2 months	Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.; Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree.; The average of the scores were calculated and analyzed monthly.
Participant's Feedback on Educational Pamphlets - Importance Scale	3 months	Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.; Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important.
Participant's Feedback on Educational Pamphlets - Expectations Scale	3 months	Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles.; Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective.; The average response for each questions was analyzed.

Trial Locations

Locations (6)

NeuroTrials, Inc.; 🇺🇸 Atlanta, Georgia, United States

SleepMed of Central Georgia; 🇺🇸 Macon, Georgia, United States

SleepMed of Philadelphia; 🇺🇸 Philadelphia, Pennsylvania, United States

SleepMed of South Carolina; 🇺🇸 Columbia, South Carolina, United States

Pulmonary Associates; 🇺🇸 Glendale, Arizona, United States

Arkansas Center for Sleep Medicine; 🇺🇸 Little Rock, Arkansas, United States