Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks

Study Overview
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Brief Summary
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The study is to maximize efficacy of message delivery to achieve desired Obstructive sleep apnea (OSA) adherence goal. Newly diagnosed black patients (n=390, all genders) from participating sleep clinics will be randomly exposed to either the individually tailored or standard OSA messages. Investigators will look at an effective and scalable intervention to improve OSA-related outcomes: a) clinical CVD and brain health measures and b) patient-centered outcomes. Patient-centered and adherence data will be captured via REDCap, enabling real-time application of data-driven decision rules while implementing the intervention.

Official Title
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Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks

Conditions
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Obstructive Sleep Apnea

Intervention / Treatment
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* Behavioral: Tailored Videos
* Behavioral: OSA Treatment
* Behavioral: Standard Videos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Self-reported race/ethnicity as African American, African, Caribbean or black Accessible by phone No plans to move away within the year OSA diagnosis, consent, including permission to release medical data Physician-diagnosed medical conditions. Exclusion Criteria: Progressive illnesses in which disability or death is expected within 1 year Impaired cognitive/ functional ability precluding participation Intention to move within the same year of enrollment Family member currently enrolled

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tailored Videos<br> | Behavioral: Tailored Videos<br>* web-based OSA messages (videos featuring role models and coaching advice using motivational enhancement) addressing OSA barriers within a health literacy framework--to decrease cognitive load and render messages understandable and actionable. OSA messages were tailored based on focus group data in the previous study (group tailoring).<br>|
| Active Comparator: Standard Videos<br> | Behavioral: Standard Videos<br>* Patients in the control arm will also receive an iPad, providing access to standard online OSA health information (e.g., National Sleep Foundation) in an equivalent dose as in the intervention arm using pre-selected automatic alerts to access the website<br>|
| Active Comparator: OSA Treatment<br> | Behavioral: OSA Treatment<br>* Web-based platform delivering messages promoting OSA self-efficacy. . All patients will view the introductory video, followed by the video cluster: Sleep, Health, and Well-Being; Sleep-Heart Health; Lifestyle Changes; and Sleep Hygiene.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score | The mean of the nonmissing item responses was calculated for each of the 3 subscales: Perceived Risk, Outcome Expectancies, and Treatment Self-Efficacy. Using this mean-weighted score prevents the distortion of the score from missing responses. Factor 1 (Risk Perception consisting of 8 questions); Factor 2 (Outcome Expectancy consisting of 9 items) and Factor 3 (Treatment Self Efficacy consisting of 9 items) are given a potential score of 1-4. | 2 Months and 6 Months |