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The study hypothesis: in groups receiving tailored education and feedback in a style that matches their psychological profile, will show a higher CPAP adherence rates than groups receiving mismatched tailored education / feedback, and groups that receive no tailored education and feedback (standard of care).
Three group, randomized, controlled clinical trial assessing the extent to which tailoring a CPAP intervention entailing education and feedback to the psychological profile of new CPAP users can enhance the impact of the intervention in terms of adherence-related behavior.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Active Comparator | Participants will receive education and feedback tailored to the psychological profile of the receiving participant. |
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| Control Group | Active Comparator | Participants will receive education inconsistent with their profile. |
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| Standard of care | No Intervention | Participants will not receive education or feedback. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Education and feedback | Behavioral | The education leaflets are information concerning Obstructive Sleep Apna (OSA) and CPAP treatment. The feedback reports are CPAP usage patterns. |
| Measure | Description | Time Frame |
|---|---|---|
| Nightly Adherence | Average usage hours per night | 3 months |
| Adherence | Average usage days per week. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant's Feedback on Educational Pamphlets - Expectations Scale | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective. The average response for each questions was analyzed. |
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Inclusion Criteria:
Exclusion Criteria:
Inability to provide informed consent
Presence of a comorbid condition that may potentially complicate CPAP adherence, such as:
Unstable depressive disorder
Unstable anxiety disorder
Dementia
Unable to understand study information
Obesity Hypoventilation Syndrome
Central Sleep Apnea or Complex Sleep Apnea
Facial musculoskeletal disorder
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| Name | Affiliation | Role |
|---|---|---|
| Richard Bogan, MD | SleepMed of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pulmonary Associates | Glendale | Arizona | 85306 | United States | ||
| Arkansas Center for Sleep Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37213195 | Derived | Lacroix J, Tatousek J, Den Teuling N, Visser T, Wells C, Wylie P, Rosenberg R, Bogan R. Effectiveness of an Intervention Providing Digitally Generated Personalized Feedback and Education on Adherence to Continuous Positive Airway Pressure: Randomized Controlled Trial. J Med Internet Res. 2023 May 22;25:e40193. doi: 10.2196/40193. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care | Participants will not receive education or feedback. |
| FG001 | Treatment Group | Participants will receive education and feedback tailored to the psychological profile of the receiving participant. Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| 3 months |
| Participant's Feedback on Educational Pamphlets - Importance Scale | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important. | 3 months |
| Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree. The average of each question was analyzed. | 3 months |
| Participant's Feedback on Educational Pamphlets - Motiviation | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much. The average of the questions were analyzed. | 3 months |
| Participant's Feedback on Educational Pamphlets - Leaflet Assessment | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree. The average of the scores were calculated and analyzed monthly. | 2 months |
| Little Rock |
| Arkansas |
| 72211 |
| United States |
| NeuroTrials, Inc. | Atlanta | Georgia | 30342 | United States |
| SleepMed of Central Georgia | Macon | Georgia | 31201 | United States |
| SleepMed of Philadelphia | Philadelphia | Pennsylvania | 19118 | United States |
| SleepMed of South Carolina | Columbia | South Carolina | 29201 | United States |
| FG002 | Control Group | Participants will receive education inconsistent with their profile. Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns. |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Standard of Care | Participants will not receive education or feedback. |
| BG001 | Treatment | Participants will receive education and feedback tailored to the psychological profile of the receiving participant. Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns. |
| BG002 | Control Group | Participants will receive education inconsistent with their profile. Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns. |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Apnea-Hyopnea Index | The apnea-hypopnea index (AHI) is the combined average number of apneas and hypopneas that occur per hour of sleep | Mean | Standard Deviation | events/hour |
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| Epworth Sleepiness Scale | The Epworth Sleepiness Scale is an 8 item questionnaire that measures the general level of daytime sleepiness. Participants were asked what the chance is they would doze off or fall asleep during different routine daytime situations. The survey answers questions on a scale of 0 to 3- 0 being no chance and 3 being a high chance of dozing. The lowest score possible is a 0 and the highest score possible is a 24. | Mean | Standard Deviation | units on a scale |
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| 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 | ||||||||||||||||||||||||||||
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| Primary | Nightly Adherence | Average usage hours per night | Posted | Mean | Standard Deviation | hours | 3 months |
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| Primary | Adherence | Average usage days per week. | Posted | Mean | Standard Deviation | days per week | 3 months |
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| Secondary | Participant's Feedback on Educational Pamphlets - Expectations Scale | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants answered 3 questions about the expected effectiveness of CPAP. These questions were on a scale of 0 to 5, 0 being not effective at all and 5 being extremely effective. The average response for each questions was analyzed. | As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Participant's Feedback on Educational Pamphlets - Importance Scale | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants answered one questions about the importance of CPAP. This was was on a scale of 0 to 5, 0 being not important at all and 5 extremely important. | As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Participant's Feedback on Educational Pamphlets - Self-Efficacy Scale | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants answered 5 questions regarding self-efficacy of use of CPAP. This was on a scale of 0 to 5, 0 being disagree completely and 5 being completely agree. The average of each question was analyzed. | As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Participant's Feedback on Educational Pamphlets - Motiviation | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants were asked about there motivation to use CPAP with two questions. These questions were on a scale of 0 to 10, 0 being not at all, 5 being somewhat, and 10 very much. The average of the questions were analyzed. | As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments. | Posted | Mean | Standard Deviation | units on a scale | 3 months |
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| Secondary | Participant's Feedback on Educational Pamphlets - Leaflet Assessment | Explore the difference in efficacy of the educational and feedback materials tailored to the specific psychological profiles. Participants that received the leaflet were asked 15 questions regarding it. The questions were on a scale of 0 to 5, 0 being strongly disagree and 5 being strongly agree. The average of the scores were calculated and analyzed monthly. | As the study progressed participants withdrew or were withdrawn from the study. Or they did not complete the assessments. | Posted | Mean | Standard Deviation | units on a scale | 2 months |
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All non-serious and serious adverse events were collected over the 3 month period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment | Participants will receive education and feedback tailored to the psychological profile of the receiving participant. Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns. | 0 | 48 | 0 | 48 | ||
| EG001 | Control Group | Participants will receive education inconsistent with their profile. Education and feedback: The education leaflets are information concerning OSA and CPAP treatment. The feedback reports are CPAP usage patterns. | 0 | 55 | 0 | 55 | ||
| EG002 | Standard of Care | Participants will not receive education or feedback. | 0 | 63 | 0 | 63 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Scientist | Philips Research | +31628041122 | Joyca.lacroix@philips.com |
| ID | Term |
|---|---|
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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