Trial Outcomes & Findings for Patient Perception Questionnaire Validation (NCT NCT02067000)

NCT ID: NCT02067000

Last Updated: 2020-07-15

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

217 participants

Primary outcome timeframe

Baseline and 90 days

Results posted on

2020-07-15

Participant Flow

Participant milestones

Participant milestones
Measure	Obstructive Sleep Apnea Obstructive Sleep Apnea: Questionnaire about CPAP perceptions
Overall Study STARTED	217
Overall Study COMPLETED	167
Overall Study NOT COMPLETED	50

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Patient Perception Questionnaire Validation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Obstructive Sleep Apnea n=217 Participants Obstructive Sleep Apnea: Questionnaire about CPAP perceptions
Age, Continuous	54.1 Years n=5 Participants
Sex: Female, Male Female	104 Participants n=5 Participants
Sex: Female, Male Male	113 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	170 Participants n=5 Participants
Race/Ethnicity, Customized Other	47 Participants n=5 Participants
Region of Enrollment United States	217 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 90 days

Outcome measures

Outcome measures
Measure	Obstructive Sleep Apnea n=167 Participants Obstructive Sleep Apnea: Questionnaire about CPAP perceptions
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q1	.04 r value
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q2	.14 r value
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q3	.10 r value
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q4	.13 r value
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q5	.25 r value
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q6	.01 r value
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q7	.29 r value
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q8	.16 r value
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q9	.12 r value
To Determine the Association of the Participants Baseline PPQ (Patient Perception Questionnaire) Responses to Predict Adherence to CPAP Treatment at 90 Days. Q10	.19 r value

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Obstructive Sleep Apnea n=161 Participants Obstructive Sleep Apnea: Questionnaire about CPAP perceptions
Adherence to CPAP Treatment 14 Days	335 Minutes Standard Deviation 118
Adherence to CPAP Treatment 60 Days	322 Minutes Standard Deviation 118
Adherence to CPAP Treatment 90 Days	317 Minutes Standard Deviation 119

SECONDARY outcome

Timeframe: 14 days, 60 days, 90 days

Population: Due to missing or incomplete data and drop outs, only participants who had completed all 10 questions of the PPQ were included in the analysis for each timepoint.

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.

Outcome measures

Outcome measures
Measure	Obstructive Sleep Apnea n=167 Participants Obstructive Sleep Apnea: Questionnaire about CPAP perceptions
Reliability of Patient Perception Questionnaire 14 days	6.43 units on a scale Standard Deviation 0.99
Reliability of Patient Perception Questionnaire 60 days	6.35 units on a scale Standard Deviation 0.92
Reliability of Patient Perception Questionnaire 90 days	6.06 units on a scale Standard Deviation 1.14

Adverse Events

Obstructive Sleep Apnea

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Clinical Research Scientist

Fisher and Paykel Healthcare

Phone: +64 09 574 0123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place