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临床试验/NCT02628977
NCT02628977已完成不适用

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

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 1,092 人开始时间: 2015年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,092
试验地点
1
主要终点
Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure

研究概览

简要总结

The primary purpose of this study is to ascertain the effectiveness of tailored, peer based sleep health education and social support in increasing adherence rates to recommended Obstructive Sleep Apnea (OSA) evaluation and treatment among blacks at risk of Obstructive Sleep Apnea.

详细描述

Obstructive sleep apnea (OSA), which disproportionately affects blacks (31% vs. 10%, whites), is a critical, preventable and/or treatable disease potentially causing increased cardiovascular disease (CVD) outcomes (e.g., obesity, diabetes, hypertension, stroke, arrhythmia, and chronic heart failure). Improving sleep may have direct effects in reducing CVD risk,2 enhancing brain functions, and increasing workplace productivity. Unfortunately, our focus groups suggest that most at-risk blacks are unaware of OSA symptoms or its related morbidity. Thus, it is imperative to address poor adherence among blacks with OSA, if we are to reduce health disparities associated with CVD outcomes between blacks and whites.

This is a randomized study with a total of 6 sites recruiting; 3 will serve as controls and 3 that will be intervention. Group A participants (Intervention group) will receive health education from a trained Peer Health Educator and Group B participants (Control group) will meet with a salon worker, barbershop worker, or church Health Ministry group leader. Participants will be asked to use a sleep diary and wear a home sleep test device to measure sleep for 7 days. They will be followed for 12 months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •self-reported race/ethnic minority
  • •ages ≥18 years
  • •accessible by telephone
  • •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.

排除标准

  • •are involved in another sleep study.
  • •are unable to understand and sign this informed consent form.
  • •know someone who is participating in this study.
  • •had a heart attack or stroke within the past 12 weeks.
  • •do not identify yourself as a racial/ethnic minority.
  • •are pregnant.
  • •Refuse to use the ARESTM home sleep test device.
  • •Refuse to use the WatchPATTM home sleep test device.
  • •are not at risk for sleep apnea.

研究组 & 干预措施

OSA Health Education & Support Group

Experimental

Participants randomly assigned to the intervention arm will receive OSA health education and social support from a trained Peer educator.

干预措施: Peer Based Sleep Health Education and Social Support (Behavioral)

Attention Control Group

Active Comparator

Participants in the attention control group will receive standard sleep literature, providing information about Obstructive Sleep Apnea and access to available sleep services.

干预措施: Attention Control Group (Behavioral)

结局指标

主要结局

Rate of adherence to recommended home OSA evaluation and treatment after intervention exposure

时间窗: 12 Months

We will perform analysis on an intention-to-treat basis.

次要结局

  • Rate of Obstructive Sleep Apnea among black men and women at the community level(12 Months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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