Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks
Primary Purpose
Obstructive Sleep Apnea
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Videos
OSA Treatment
Standard Videos
Sponsored by
About this trial
This is an interventional prevention trial for Obstructive Sleep Apnea
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Tailored Videos
Standard Videos
OSA Treatment
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03354520
First Posted
November 21, 2017
Last Updated
February 7, 2022
Sponsor
NYU Langone Health
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
1. Study Identification
Unique Protocol Identification Number
NCT03354520
Brief Title
Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks
Official Title
Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Withdrawn
Why Stopped
PI departure from institution
Study Start Date
June 18, 2021 (Actual)
Primary Completion Date
June 18, 2021 (Actual)
Study Completion Date
June 18, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
National Institute on Minority Health and Health Disparities (NIMHD)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tailored Videos
Arm Type
Active Comparator
Arm Title
Standard Videos
Arm Type
Active Comparator
Arm Title
OSA Treatment
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Tailored Videos
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
OSA Treatment
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Standard Videos
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score
Description
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.
Time Frame
2 Months and 6 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Girardin Jean-Louis, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication.
IPD Sharing Access Criteria
Requests should be directed to Ferdinand.Zizi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.
Learn more about this trial
Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks
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