- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02067000
Patient Perception Questionnaire Validation
July 13, 2020 updated by: Fisher and Paykel Healthcare
Validation of the Patient Perception Questionnaire
Validation of the patient perception questionnaire relating to CPAP use
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This research is designed to validate a questionnaire which aims to predict patient adherence to CPAP, therefore enabling the healthcare provider to better target initiatives to improve adherence.
Study Type
Observational
Enrollment (Actual)
217
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Missouri
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Saint Louis, Missouri, United States, 63143
- Clayton Sleep Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
OSA patients
Description
Inclusion Criteria:
- Mild-severe OSA patients
- Over 18
- Naive to CPAP
- Fluent english
Exclusion Criteria:
- Comorbidities
- Other sleep disorders
- Inability to tolerate CPAP
- Shift worker
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Obstructive Sleep Apnea
|
Questionnaire about CPAP perceptions
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days.
Time Frame: Baseline and 90 days
|
The PPQ is a custom questionnaire including 10 questions evaluating perceptions of OSA and CPAP treatment.
Each question is derived from models of psychology such as self-regulatory ability and social support.
Q1 ranges from 0-10, with 10 indicating OSA negatively impacts life.
Q2 ranges from 0-10, with 10 indicating belief that OSA will last forever.
Q3 ranges from 0-10, with 10 indicating that CPAP is extremely necessary to control OSA.
Q4 ranges from 1-10, with 10 indicating no intention of using CPAP at all.
Q5 ranges from 1-10, with 10 indicating presence of a highly supportive spouse.
Q6 ranges from 1-10, with 10 indicating benefit of CPAP is well understood.
Q7 ranges from 0-10, with 10 indicating extreme concern about using CPAP.
Q8 ranges from 1-10, with 10 indicating high confidence with using CPAP.
Q9 ranges from 1-10, with 10 indicating high perception that CPAP will help treat OSA.
Q10 ranges from 1-10, with 10 indicating spouses negative attitude toward CPAP use.
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Baseline and 90 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adherence to CPAP Treatment
Time Frame: 14 Days, 60 Days, 90 Days
|
An assessment of participants adherence to CPAP treatment after 90 days.
Data was extracted from CPAP device compliance reports.Adherence was defined as use for 4 hours or more per night for 70% of nights in each report period at 14, 60 and 90 days.
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14 Days, 60 Days, 90 Days
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Reliability of Patient Perception Questionnaire
Time Frame: 14 days, 60 days, 90 days
|
To determine the stability/consistency (reliability) of the PPQ at three time points during the first 90 days of CPAP treatment usage.
At each of these time points, the exact same PPQ as described in the Primary Outcome Measure was re-administered to determine whether the scores remained consistent over time.
The answer responses described in the Primary Outcome measure also remain the same.
Total PPQ was calculated as an average of the 10 questions.
Total score ranges from 0-10 with higher scores indicating a worse outcome.
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14 days, 60 days, 90 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Eric Powell, Clayton Sleep Institute
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2011
Primary Completion (Actual)
February 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
September 12, 2013
First Submitted That Met QC Criteria
February 18, 2014
First Posted (Estimate)
February 20, 2014
Study Record Updates
Last Update Posted (Actual)
July 15, 2020
Last Update Submitted That Met QC Criteria
July 13, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CIA-44
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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