Peer-Enhanced Education to Reduce Sleep Ethnic Disparities

Obstructive Sleep Apnea Clinical Trial

— PEERS-ED  

Official title:

Tailored Peer-Based Sleep Health Education and Social Support Among Blacks With Obstructive Sleep Apnea

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02427815
• Other study ID #: NYULagone
• Status: Recruiting
• Phase: N/A
• First received: April 20, 2015
• Last updated: March 27, 2017
• Start date: May 2014
• Est. completion date: May 2019

Study information

• Verified date: March 2017
• Source: New York University Langone Medical Center
• Contact: Azizi Seixas, PhD
• Phone: 646-501-2672
• Email: azizi.seixas[@]nyumc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Reducing sleep health disparities was recognized as a priority area for intervention by the National Institutes of Health. Sleep apnea, which disproportionately affects minorities, is an important preventable and treatable disease that should be targeted as it is associated with increased cardiovascular risk and disease outcomes, including obesity, diabetes, hypertension, stroke, cardiac arrhythmia, and chronic heart failure. Evidence from previous research suggests that most minorities are unaware of general sleep problems, such as sleep apnea symptoms and the negative effects on cardiovascular disease. Only 26% of minorities participating in the investigators prior research followed up on recommended sleep apnea screening, although 39% were at high risk for sleep apnea. While few followed the physician's recommendations, 90% of those assessed received a sleep apnea diagnosis. The investigators research will assess the effectiveness of peer-based sleep health education and social support in increasing sleep apnea screening and treatment rates among minorities with sleep apnea risk. Participants will receive quality-controlled and culturally tailored peer education using a sleep health education manual. They will each receive up to 4 sessions promoting sleep apnea screening during a 6-month period. Those with a diagnosis will receive 2 additional sessions promoting sleep apnea treatment adherence, in conjunction with telephone interventions. The investigators research will also assess the rate of sleep apnea among minorities using home recordings. The long-term goal of the investigators study is to apply this intervention in community-based settings (barbershops, beauty salons, churches, and health centers), thereby linking community health promotion to the healthcare system.

Description:

Primary Aim: To ascertain effectiveness of tailored, peer-based sleep health education and social support in increasing adherence rates to recommended OSA evaluation and treatment among blacks at risk for OSA.

Secondary Aim: To ascertain the rate of OSA among black men and women at the community level using home-based sleep recordings in accordance with criteria from the American Academy of Sleep Medicine.

Hypotheses: Among blacks at risk for OSA, those randomized to receive peer-based sleep health education and social support, compared with those randomized to the attention-control group, will have:

• Greater adherence to physician-recommended OSA evaluation using home sleep recordings.

• Greater adherence to OSA treatment using telemetry (CPAP use [>4 hrs. a night for 70% of the nights]).

• Individual-level factors (OSA knowledge, OSA self-efficacy, and past evaluation behavior) and contextual level factors (i.e., trust/rapport with peer educators, family network, and socioeconomic position) will mediate effects of peer education on adherence to OSA evaluation and recommended treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 398
• Est. completion date: May 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• self-reported race/ethnicity as black

• ages =18 years

• accessible by telephone

• no plans to move away from the region within the year following enrollment

• consent to participate, which includes permission to release medical record information

• A positive screening for OSA is necessary to be enrolled in the intervention protocol.

Exclusion Criteria:

• are involved in another sleep study.

• are unable to understand and sign this informed consent form.

• know someone who is participating in this study.

• plan to move away in the next two years.

• had a heart attack or stroke within the past 12 weeks.

• do not identify yourself as Black or African American.

• are pregnant.

• are not at risk for sleep apnea.

• refuse to use the Apnea Risk Evaluation System (ARES) home sleep test device.

Related Conditions & MeSH terms

• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Behavioral:
• Intervention Group
Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer Educator.

Locations

Country	Name	City	State
United States	NYULMC Department of Population Health - Center for Healthful Behavior Change	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Dr. Girardin Jean-Louis	New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of participants to adhere to CPAP treatment	Following recommended treatment of CPAP machine.	0-12 months
Primary	Number of participants to complete home study	In this phase the successful completion of a 7 day sleep home study.	0-12 months
Secondary	Number of participants to complete a sleep clinic test	Participants complete an overnight clinical sleep test for diagnosing obstructive sleep apnea as well as customizing of continuous positive airway treatment.	0-12 months