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Completed

NCT Number: NCT02195531

CPAP (Continuous Positive Airway Pressure) Study 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).

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Key information

Conditions

Adherence

Age range

21 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary Associates, Glendale, Arizona, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Education and Feedback

Behavioral

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

Primary outcomes

  1. Nightly Adherence

    Time frame: 3 months

    Average usage hours per night

  2. Adherence

    Time frame: 3 months

    Average usage days per week.

Secondary outcomes

  1. Participant's Feedback on Educational Pamphlets - Expectations Scale

    Time frame: 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.

  2. Participant's Feedback on Educational Pamphlets - Importance Scale

    Time frame: 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.

  3. Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale

    Time frame: 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.

  4. Participant's Feedback on Educational Pamphlets - Motiviation

    Time frame: 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.

  5. Participant's Feedback on Educational Pamphlets - Leaflet Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Philips Respironics

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 21, 2014
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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