Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Validation of the patient perception questionnaire relating to CPAP use
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Obstructive Sleep Apnea |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Obstructive Sleep Apnea | Behavioral | Questionnaire about CPAP perceptions |
|
| 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. | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
OSA patients
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Eric Powell | Clayton Sleep Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clayton Sleep Institute | St Louis | Missouri | 63143 | United States |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Obstructive Sleep Apnea | Obstructive Sleep Apnea: Questionnaire about CPAP perceptions |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Obstructive Sleep Apnea | Obstructive Sleep Apnea: Questionnaire about CPAP perceptions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | r value | Baseline and 90 days |
|
90 Days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Obstructive Sleep Apnea | Obstructive Sleep Apnea: Questionnaire about CPAP perceptions |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Research Scientist | Fisher and Paykel Healthcare | +64 09 574 0123 | 7044 | CPAPtrial@fphcare.co.nz |
Not provided
| ID | Term |
|---|---|
| D020181 | Sleep Apnea, Obstructive |
| ID | Term |
|---|---|
| D012891 | Sleep Apnea Syndromes |
| D001049 | Apnea |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Description |
|---|
| OG000 | Obstructive Sleep Apnea | Obstructive Sleep Apnea: Questionnaire about CPAP perceptions |
|
|
| 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. | Posted | Mean | Standard Deviation | Minutes | 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. | 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. | Posted | Mean | Standard Deviation | units on a scale | 14 days, 60 days, 90 days |
|
|
|
| 0 |
| 217 |
| 0 |
| 217 |
| 0 |
| 217 |
Not provided
Not provided
| D020919 |
| Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
| Title |
|---|
| Measurements |
|---|
|
|
| 90 days |
|
|