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

NYU Langone Health

Status: Completed

Conditions: Obstructive Sleep Apnea

Treatments: Behavioral: Adherence to Sleep Apnea Treatment; Other: Standard Care Group

Study type: Interventional

Funder types: Other

Identifiers

NCT01946659

09-193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 344 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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344 participants in 2 patient groups

Adherence to Sleep Apnea Treatment

Experimental group

Description:

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

Treatment:

Behavioral: Adherence to Sleep Apnea Treatment

Standard Care Group

Other group

Description:

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

Treatment:

Other: Standard Care Group