Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome (MetSO)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by New York University School of Medicine
Sponsor:
Collaborator:
State University of New York - Downstate Medical Center
Information provided by (Responsible Party):
Girardin Jean-Louis, New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT01946659
First received: February 5, 2013
Last updated: September 16, 2013
Last verified: September 2013

February 5, 2013
September 16, 2013
September 2009
September 2013   (final data collection date for primary outcome measure)
Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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 CPAP machine.
Same as current
Complete list of historical versions of study NCT01946659 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Components of Metabolic syndrome include Hypertension, Diabetes, weight, triglyceride and cholesterol.
Same as current
Not Provided
Not Provided
 
Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome
Promoting Adherence to Sleep Apnea Treatment Through Health Education Among Blacks With Metabolic Syndrome

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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Obstructive Sleep Apnea
  • 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
  • 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
  • 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.
    Intervention: Behavioral: Adherence to Sleep Apnea Treatment
  • Standard Care Group
    The standard care group gets the standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine.
    Intervention: Other: Standard Care Group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
340
April 2014
September 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Age > 18 years
  • African American / Carribean American / African.

Exclusion Criteria:

  • 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 OSA and/or on treatment
Both
18 Years to 85 Years
No
United States
 
NCT01946659
09-193
No
Girardin Jean-Louis, New York University School of Medicine
New York University School of Medicine
State University of New York - Downstate Medical Center
Principal Investigator: Girardin Jean-Louis, PhD New York University School of Medicine
New York University School of Medicine
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP