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Promoting Adherence to Sleep Apnea Treatment Among Blacks With Metabolic Syndrome

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01946659
Acronym
MetSO
Enrollment
344
Registered
2013-09-19
Start date
2009-09-30
Completion date
2014-12-31
Last updated
2015-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obstructive Sleep Apnea

Keywords

Tailored Telephone Intervention

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.

Interventions

BEHAVIORALAdherence 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.

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

Sponsors

State University of New York - Downstate Medical Center
CollaboratorOTHER
NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Change the knowledge of risk factors for sleep apnea and improve adherence to recommended assessment and treatment for sleep apnea.6 monthsThe 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

MeasureTime frameDescription
Change in the components of metabolic syndrome (as measured by Hba1c, triglycerides, and Blood pressure) for those who adhered to the treatment of Sleep Apnea6 monthsComponents of Metabolic syndrome include Hypertension, Diabetes, weight, triglyceride and cholesterol.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 20, 2026