Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome
MetSO
1 other identifier
interventional
344
1 country
1
Brief Summary
This is a randomized controlled Trial to evaluate effect of a culturally and linguistically tailored, telephone-delivered behavioral intervention on adherence to recommended assessment and treatment of sleep apnea in Blacks with Metabolic Syndrome. The investigators believe low awareness of Sleep Apnea and the risk it imposes to an individual health plays an important role in underdiagnosis and low adherence to treatment among Blacks. Hence, culturally and linguistically tailored health education will decrease the knowledge gap and improve adherence to recommended assessment and treatment of sleep Apnea. the investigators believe the effect of adherence to treatment of Sleep apnea is shown to improve the components of Metabolic syndrome and hence promote well control of Hypertension, Diabetes, weight, triglyceride and cholesterol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 5, 2013
CompletedFirst Posted
Study publicly available on registry
September 19, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedSeptember 11, 2015
September 1, 2015
5.3 years
February 5, 2013
September 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea.
The knowledge of risk factors for sleep apnea will be measured by the Apnea knowledge/Apnea beliefs Scale. The adherence to recommended assessment and treatment for sleep apnea will be measured by Continuos Positive Airway Pressure machine.
6 months
Secondary Outcomes (1)
Change in the components of metabolic syndrome (as measured by Hba1c, triglycerides, and Blood pressure) for those who adhered to the treatment of Sleep Apnea
6 months
Study Arms (2)
Adherence to Sleep Apnea Treatment
EXPERIMENTALThe intervention arm of the study receives tailored education regarding Sleep Apnea by the study health educator via telephone.
Standard Care Group
OTHERThe standard care group gets the standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine.
Interventions
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.
The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine
Eligibility Criteria
You may qualify if:
- Age \> 18 years
- African American / carribean American / African.
You may not qualify if:
- Pregnancy or breastfeeding
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University
New York, New York, 10016, United States
Related Publications (3)
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.
PMID: 28364475DERIVEDRamos 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.
PMID: 25856540DERIVEDWilliams 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.
PMID: 24925227DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Girardin Jean-Louis, PhD
NYU Langone Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 5, 2013
First Posted
September 19, 2013
Study Start
September 1, 2009
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
September 11, 2015
Record last verified: 2015-09