Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Promoting Adherence to Sleep Apnea Treatment Through Health Education Among Blacks With Metabolic Syndrome

Conditions
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Obstructive Sleep Apnea

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adherence to Sleep Apnea Treatment<br>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<br>* 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.<br>* Other names: Linguistically and culturally tailored intervention;|
| Other: Standard Care Group<br>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<br>* The standard care group gets a standard print communications about sleep apnea produced by NLHBI and American Academy of Sleep Medicine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tailored Telephone Intervention