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

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ClinicalTrials.gov Identifier: NCT03354520
Recruitment Status : Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
National Institute on Minority Health and Health Disparities (NIMHD)
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea Behavioral: Tailored Videos Behavioral: OSA Treatment Behavioral: Standard Videos Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 390 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Optimizing Treatment Effects on OSA-related Clinical and Patient-centered Outcomes Among Blacks
Estimated Study Start Date : September 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Tailored Videos Behavioral: Tailored Videos
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).

Active Comparator: Standard Videos Behavioral: Standard Videos
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

Active Comparator: OSA Treatment Behavioral: OSA Treatment
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.




Primary Outcome Measures :
  1. Change from Baseline OSA Self-Efficacy Scale Score to 6 Months Score [ Time Frame: 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354520


Contacts
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Contact: Lloyd Gyamfi 646 501 2613 Lloyd.Gyamfi@nyumc.org

Locations
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United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Lloyd Gyamfi    646-501-2613    Lloyd.gyamfi@nyumc.org   
Principal Investigator: Girardin Jean-Louis, PhD         
Sponsors and Collaborators
NYU Langone Health
National Institute on Minority Health and Health Disparities (NIMHD)
Investigators
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Principal Investigator: Girardin Jean-Louis, PhD NYU Langone Health

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03354520     History of Changes
Other Study ID Numbers: 17-01097
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: March 6, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Beginning 3 months and ending 5 years following article publication.
Access Criteria: Requests should be directed to Ferdinand.Zizi@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sleep Apnea, Obstructive
Sleep Apnea Syndromes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases