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

N/ACompletedNCT02195531

Philips Respironics169 enrolled

Overview

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).

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

169

Conditions

Adherence

Interventions

Education and feedbackBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 21 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (6)

Pulmonary Associates

Glendale, Arizona, United States

Arkansas Center for Sleep Medicine

Little Rock, Arkansas, United States

NeuroTrials, Inc.

Atlanta, Georgia, United States

SleepMed of Central Georgia

Macon, Georgia, United States

Outcomes

Primary Outcomes

Nightly Adherence

Average usage hours per night

Time frame: 3 months

Adherence

Average usage days per week.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Data from ClinicalTrials.gov

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