Clinical trial NCT02195531: CPAP (Continuous Positive Airway Pressure) Study Educational Materials and Usage Feedback to Promote CPAP Adherence
Official title: BIG4 - CPAP Educational Materials and Usage Feedback to Promote CPAP Adherence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adherence
Keywords: Adherence
Lead sponsor: Philips Respironics
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 169
Sex: ALL
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Nightly Adherence
timeFrame: 3 months
measure: Adherence
timeFrame: 3 months
Secondary outcomes:
measure: Participant's Feedback on Educational Pamphlets - Expectations Scale
timeFrame: 3 months
measure: Participant's Feedback on Educational Pamphlets - Importance Scale
timeFrame: 3 months
measure: Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale
timeFrame: 3 months
measure: Participant's Feedback on Educational Pamphlets - Motiviation
timeFrame: 3 months
measure: Participant's Feedback on Educational Pamphlets - Leaflet Assessment
timeFrame: 2 months
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Pulmonary Associates
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Center for Sleep Medicine
state: Arkansas
city: Atlanta
country: United States
facility: NeuroTrials, Inc.
state: Georgia
city: Macon
country: United States
facility: SleepMed of Central Georgia
state: Georgia
city: Philadelphia
country: United States
facility: SleepMed of Philadelphia
state: Pennsylvania
city: Columbia
country: United States
facility: SleepMed of South Carolina
state: South Carolina
Study officials:
affiliation: SleepMed of South Carolina
name: Richard Bogan, MD
role: PRINCIPAL_INVESTIGATOR
References: