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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02195531
Other study ID # PGI-BIG4-1331-MS
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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