Patient Perception Questionnaire Validation

Obstructive Sleep Apnea Clinical Trial

Official title:

Validation of the Patient Perception Questionnaire

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02067000
• Other study ID #: CIA-44
• Status: Completed
• Start date: April 2011
• Est. completion date: April 2012

Study information

• Verified date: July 2020
• Source: Fisher and Paykel Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Validation of the patient perception questionnaire relating to CPAP use

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 217
• Est. completion date: April 2012
• Est. primary completion date: February 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Obstructive Sleep Apnea
Questionnaire about CPAP perceptions

Locations

Country	Name	City	State
United States	Clayton Sleep Institute	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Fisher and Paykel Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 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.	Baseline and 90 days
Secondary	Adherence to CPAP Treatment	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.	14 Days, 60 Days, 90 Days
Secondary	Reliability of Patient Perception Questionnaire	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.	14 days, 60 days, 90 days