Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome (MetSO)
|ClinicalTrials.gov Identifier: NCT01946659|
Recruitment Status : Completed
First Posted : September 19, 2013
Last Update Posted : September 11, 2015
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea||Behavioral: Adherence to Sleep Apnea Treatment Other: Standard Care Group||Not Applicable|
Primary aim: To evaluate effect of a culturally and linguistically tailored, telephone-delivered behavioral intervention, versus an attention-control condition, on adherence to recommended assessment and treatment of sleep apnea.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||344 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Promoting Adherence to Sleep Apnea Treatment Through Health Education Among Blacks With Metabolic Syndrome|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
U.S. FDA Resources
Experimental: Adherence to Sleep Apnea Treatment
The intervention arm of the study receives tailored education regarding Sleep Apnea by the study health educator via telephone.
Behavioral: 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.
Other Name: Linguistically and culturally tailored intervention
Standard Care Group
The standard care group gets the standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine.
Other: Standard Care Group
The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine
- Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea. [ Time Frame: 6 months ]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.
- 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 [ Time Frame: 6 months ]Components of Metabolic syndrome include Hypertension, Diabetes, weight, triglyceride and cholesterol.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01946659
|United States, New York|
|New York University|
|New York, New York, United States, 10016|
|Principal Investigator:||Girardin Jean-Louis, PhD||New York University School of Medicine|