Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome
NCT ID: NCT01946659
Last Updated: 2015-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
344 participants
INTERVENTIONAL
2009-09-30
2014-12-31
Brief Summary
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Detailed Description
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Secondary aims: 1) To evaluate the maintenance of intervention effects on adherence 6 months post-intervention; and 2) To assess treatment effects on components of the metabolic syndrome (waist circumference, blood pressure, lipid level, and fasting plasma glucose/HbA1C).
Exploratory aim: To identify the mediators of adherence to recommended sleep apnea assessment and treatment following exposure to the intervention.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
DOUBLE
Study Groups
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Adherence to Sleep Apnea Treatment
The intervention arm of the study receives tailored education regarding Sleep Apnea by the study health educator via telephone.
Adherence to Sleep Apnea Treatment
A health education material prepared after focus group discussion with community leaders and patients would be administered to the participants with an experienced health educator through phone. Upto 10 calls per each patient will be made to either group until 6 months or the patient has a sleep test done.
Standard Care Group
The standard care group gets the standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine.
Standard Care Group
The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine
Interventions
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Adherence to Sleep Apnea Treatment
A health education material prepared after focus group discussion with community leaders and patients would be administered to the participants with an experienced health educator through phone. Upto 10 calls per each patient will be made to either group until 6 months or the patient has a sleep test done.
Standard Care Group
The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* African American / carribean American / African.
Exclusion Criteria
* Involvement with other study
* Unable to understand and sign the informed consent form
* Heart attack or stroke within the past 12 weeks
* Diagnosed with Obstructive Sleep Apnea and/or on treatment
18 Years
85 Years
ALL
No
Sponsors
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State University of New York - Downstate Medical Center
OTHER
NYU Langone Health
OTHER
Responsible Party
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Principal Investigators
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Girardin Jean-Louis, PhD
Role: PRINCIPAL_INVESTIGATOR
NYU Langone Health
Locations
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New York University
New York, New York, United States
Countries
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References
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Jean-Louis G, Newsome V, Williams NJ, Zizi F, Ravenell J, Ogedegbe G. Tailored Behavioral Intervention Among Blacks With Metabolic Syndrome and Sleep Apnea: Results of the MetSO Trial. Sleep. 2017 Jan 1;40(1):zsw008. doi: 10.1093/sleep/zsw008.
Ramos AR, Wallace DM, Pandi-Perumal SR, Williams NJ, Castor C, Sevick MA, Mcfarlane SI, Jean-Louis G. Associations between sleep disturbances and diabetes mellitus among blacks with metabolic syndrome: Results from the Metabolic Syndrome Outcome Study (MetSO). Ann Med. 2015 May;47(3):233-7. doi: 10.3109/07853890.2015.1015601. Epub 2015 Apr 9.
Williams NJ, Jean-Louis G, Brown CD, McFarlane SI, Boutin-Foster C, Ogedegbe G. Telephone-delivered behavioral intervention among blacks with sleep apnea and metabolic syndrome: study protocol for a randomized controlled trial. Trials. 2014 Jun 12;15:225. doi: 10.1186/1745-6215-15-225.
Other Identifiers
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09-193
Identifier Type: -
Identifier Source: org_study_id
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