Patient Perception Questionnaire Validation

Completed

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: Obstructive Sleep Apnea

• Registration Number: NCT02067000
• Lead Sponsor: Fisher and Paykel Healthcare

Brief Summary

Validation of the patient perception questionnaire relating to CPAP use

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 Timeline

• Study Start: 2011-04
• Primary Completion: 2012-02
• Study Completion: 2012-04
• Study First Submitted: 2013-09-12
• Study First Submitted QC: 2014-02-18
• Study First Posted: 2014-02-20
• Results First Submitted: 2017-08-10
• Status Verified: 2020-07
• Results First Submitted QC: 2020-07-13
• Last Update Submitted: 2020-07-13
• Results First Posted: 2020-07-15
• Last Update Posted: 2020-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 217

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Obstructive Sleep Apnea	Obstructive Sleep Apnea	-

Primary Outcome Measures

Name	Time	Method
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days.	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.

Secondary Outcome Measures

Name	Time	Method
Adherence to CPAP Treatment	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.
Reliability of Patient Perception Questionnaire	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.

Trial Locations

Locations (1)

Clayton Sleep Institute; 🇺🇸 Saint Louis, Missouri, United States