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
  Purpose

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 Intervention
Obstructive Sleep Apnea
Behavioral: Adherence to Sleep Apnea Treatment
Other: Standard Care Group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Diagnostic
Official Title: Promoting Adherence to Sleep Apnea Treatment Through Health Education Among Blacks With Metabolic Syndrome

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 340
Study Start Date: September 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01946659

Locations
United States, New York
New York University Recruiting
New York, New York, United States, 10016
Contact: GIrardin Jean-Louis    646-501-2623    girardin.jean-louis@nyumc.org   
Contact: Ferdinand Zizi    646-501-9803    ferdinand.zizi@nyumc.org   
Principal Investigator: Girardin Jean-Louis, PhD         
Sponsors and Collaborators
New York University School of Medicine
State University of New York - Downstate Medical Center
Investigators
Principal Investigator: Girardin Jean-Louis, PhD New York University School of Medicine
  More Information

No publications provided by New York University School of Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Girardin Jean-Louis, Professor, New York University School of Medicine
ClinicalTrials.gov Identifier: NCT01946659     History of Changes
Other Study ID Numbers: 09-193
Study First Received: February 5, 2013
Last Updated: September 16, 2013
Health Authority: United States: Federal Government

Keywords provided by New York University School of Medicine:
Tailored Telephone Intervention

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Metabolic Syndrome X
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 29, 2014