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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Adherence to Sleep Apnea Treatment
Standard Care Group
Sponsored by
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Obstructive Sleep Apnea focused on measuring Tailored Telephone Intervention

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • New York University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Adherence to Sleep Apnea Treatment

Standard Care Group

Arm Description

The intervention arm of the study receives tailored education regarding Sleep Apnea by the study health educator via telephone.

The standard care group gets the standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine.

Outcomes

Primary Outcome Measures

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.

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

Full Information

First Posted
February 5, 2013
Last Updated
September 9, 2015
Sponsor
NYU Langone Health
Collaborators
State University of New York - Downstate Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01946659
Brief Title
Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome
Acronym
MetSO
Official Title
Promoting Adherence to Sleep Apnea Treatment Through Health Education Among Blacks With Metabolic Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
Collaborators
State University of New York - Downstate Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
Tailored Telephone Intervention

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
344 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Adherence to Sleep Apnea Treatment
Arm Type
Experimental
Arm Description
The intervention arm of the study receives tailored education regarding Sleep Apnea by the study health educator via telephone.
Arm Title
Standard Care Group
Arm Type
Other
Arm Description
The standard care group gets the standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine.
Intervention Type
Behavioral
Intervention Name(s)
Adherence to Sleep Apnea Treatment
Other Intervention Name(s)
Linguistically and culturally tailored intervention
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard Care Group
Intervention Description
The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine
Primary Outcome Measure Information:
Title
Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea.
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Description
Components of Metabolic syndrome include Hypertension, Diabetes, weight, triglyceride and cholesterol.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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 Obstructive Sleep Apnea and/or on treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Girardin Jean-Louis, PhD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28364475
Citation
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.
Results Reference
derived
PubMed Identifier
25856540
Citation
Ramos 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.
Results Reference
derived
PubMed Identifier
24925227
Citation
Williams 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.
Results Reference
derived

Learn more about this trial

Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome

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