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

BIG4 - CPAP Educational Materials and Usage Feedback to Promote CPAP Adherence

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).

Study Overview

• Status: Completed
• Conditions: Adherence
• Intervention / Treatment: Behavioral: Education and feedback

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 Type: Interventional
• Enrollment (Actual): 169
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Pulmonary Associates
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Center for Sleep Medicine
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • NeuroTrials, Inc.
    • Macon, Georgia, United States, 31201
      • SleepMed of Central Georgia
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19118
      • SleepMed of Philadelphia
  • South Carolina
    • Columbia, South Carolina, United States, 29201
      • Sleepmed of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; Participants will receive education and feedback tailored to the psychological profile of the receiving participant.	Behavioral: Education and feedback; The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.; Other Names: Education; Motivational Enhancement technique
Active Comparator: Control Group; Participants will receive education inconsistent with their profile.	Behavioral: Education and feedback; The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.; Other Names: Education; Motivational Enhancement technique
No Intervention: Standard of care; Participants will not receive education or feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nightly Adherence	Average usage hours per night	3 months
Adherence	Average usage days per week.	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Participant's Feedback on Educational Pamphlets - Expectations Scale	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.	3 months
Participant's Feedback on Educational Pamphlets - Importance Scale	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.	3 months
Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale	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.	3 months
Participant's Feedback on Educational Pamphlets - Motiviation	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.	3 months
Participant's Feedback on Educational Pamphlets - Leaflet Assessment	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.	2 months

Collaborators and Investigators

• Sponsor: Philips Respironics
• Investigators: Principal Investigator: Richard Bogan, MD, Sleepmed of South Carolina

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): May 1, 2015
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: July 14, 2014
• First Submitted That Met QC Criteria: July 16, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): April 5, 2019
• Last Update Submitted That Met QC Criteria: January 8, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Adherence
• Other Study ID Numbers: PGI-BIG4-1331-MS