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

Sponsor
NYU Langone Health (Other)
Overall Status
Completed
CT.gov ID
NCT01946659
Collaborator
State University of New York - Downstate Medical Center (Other)
344
Enrollment
1
Location
2
Arms
63
Duration (Months)
5.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adherence to Sleep Apnea Treatment
  • Other: Standard Care Group
 N/A

Detailed Description

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 Design

Study Type:
Interventional
Actual Enrollment :
344 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Diagnostic
Official Title:
Promoting Adherence to Sleep Apnea Treatment Through Health Education Among Blacks With Metabolic Syndrome
Study Start Date :
Sep 1, 2009
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • Linguistically and culturally tailored intervention

    		•
    Other: 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

    Outcome Measures

    Primary Outcome Measures

    1. Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea. [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.

    Secondary Outcome Measures

    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]

      Components of Metabolic syndrome include Hypertension, Diabetes, weight, triglyceride and cholesterol.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 Obstructive Sleep Apnea and/or on treatment

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 New York University New York New York United States 10016

    Sponsors and Collaborators

    • NYU Langone Health
    • State University of New York - Downstate Medical Center

    Investigators

    • Principal Investigator: Girardin Jean-Louis, PhD, NYU Langone Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NYU Langone Health
    ClinicalTrials.gov Identifier:
    NCT01946659
    Other Study ID Numbers:
    • 09-193
    First Posted:
    Sep 19, 2013
    Last Update Posted:
    Sep 11, 2015
    Last Verified:
    Sep 1, 2015
    Keywords provided by NYU Langone Health
    Tailored Telephone Intervention
    Additional relevant MeSH terms:
    Apnea
    Sleep Apnea Syndromes
    Sleep Apnea, Obstructive
    Metabolic Syndrome

    Study Results

    No Results Posted as of Sep 11, 2015