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临床试验/NCT02538419
NCT02538419已完成不适用

Group-based Peer Support Versus Individual Education for Patients Undergoing CPAP Treatment

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年10月最近更新:
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
40
试验地点
2
主要终点
Adherence

研究概览

简要总结

The investigators will compare two alternatives designed to maximize adherence to continuous positive airway pressure (CPAP) therapy for obstructive sleep apnea (OSA) - peer-support administered in groups, versus individual education.

详细描述

The study is a 6-week, open-label, parallel-arm, randomized controlled trial comparing peer support and individual education (the latter of which was designed to mimic usual care). Participants in the peer-support (intervention) arm will be encouraged to attend two peer-support sessions, with one session occurring immediately prior to beginning CPAP and the other occurring two weeks later. Participants in the individual education (comparator) arm will begin CPAP without attendance at any peer-support sessions.

研究设计

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

入排标准

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

入选标准

  • Diagnosed with obstructive sleep apnea (no cut-off for severity)
  • Prescribed continuous positive airway pressure

排除标准

  • Not fluent in English
  • Prior CPAP use at home
  • Current use of any non-CPAP treatment for obstructive sleep apnea
  • A co-morbid sleep disorder
  • Use of supplemental oxygen
  • A clinical need for urgent CPAP therapy

研究组 & 干预措施

CPAP + Peer Support

Active Comparator

Participants randomized to this arm will receive support from a 'CPAP Peer Leader', delivered as part of a group of other participants as well as targeted one-on-one support throughout the study.

All participants will receive CPAP in addition to this intervention.

干预措施: CPAP + Peer Support (Behavioral)

CPAP + Individual Education

Active Comparator

Participants randomized to this arm will receive individual support and education from a trained investigator.

All participants will receive CPAP in addition to this intervention.

干预措施: CPAP + Individual Education (Behavioral)

结局指标

主要结局

Adherence

时间窗: 6 weeks

Objective adherence to CPAP, measured in hours per night.

次要结局

  • FOSQ(6 weeks)
  • SEMSA - Outcome Expectations(6 weeks)
  • Percentage of Participants With Adherence >=4 Hours/Night on Average(6 weeks)
  • SEMSA - Perceived Risk(6 weeks)
  • SEMSA - Self Efficacy(6 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Susan Redline

Professor of Medicine

Brigham and Women's Hospital

研究点 (2)

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