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

Adherence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195531
• Other study ID #: PGI-BIG4-1331-MS
• Status: Completed
• Phase: N/A
• Start date: January 2014
• Est. completion date: May 2015

Study information

• Verified date: January 2019
• Source: Philips Respironics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 169
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Adherence

Intervention

Behavioral:
• Education and feedback
The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns.

Locations

Country	Name	City	State
United States	NeuroTrials, Inc.	Atlanta	Georgia
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	SleepMed of Central Georgia	Macon	Georgia
United States	SleepMed of Philadelphia	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Philips Respironics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nightly Adherence	Average usage hours per night	3 months
Primary	Adherence	Average usage days per week.	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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