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

Not Applicable

Withdrawn

• Conditions: Obstructive Sleep Apnea
• Interventions: Behavioral: OSA Treatment; Behavioral: Standard Videos; Behavioral: Tailored Videos

• Registration Number: NCT03354520
• Lead Sponsor: NYU Langone Health

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-21
• Study First Submitted QC: 2017-11-24
• Study First Posted: 2017-11-28
• Study Start: 2021-06-18
• Primary Completion: 2021-06-18
• Study Completion: 2021-06-18
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-07
• Last Update Posted: 2022-02-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
OSA Treatment	OSA Treatment	-
Standard Videos	Standard Videos	-
Tailored Videos	Tailored Videos	-

Primary Outcome Measures

Name	Time	Method
Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score	2 Months and 6 Months	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States