跳至主要内容
临床试验/NCT04209985
NCT04209985已完成不适用

Reaching for Equity in Sleep Apnea Treatment (REST): Pilot of Telephonic Health Coaching Intervention to Improve Adherence to Sleep Apnea Treatment

University of California, San Francisco2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2020年11月18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
27
试验地点
2
主要终点
Mean number of hours used on average over the last 30 days

研究概览

简要总结

This study will test a brief telephonic health coaching intervention to improve adherence to positive airway pressure therapy for treatment of obstructive sleep apnea.

详细描述

The investigators will carry out a pilot study in which patients will be randomly assigned to receive health coaching or usual care. Participants are English- and Spanish-speaking patients from a county-based public health system who have received a positive airway pressure device for the treatment of sleep apnea. An unlicensed, trained health coach will call patients three times to resolve barriers to adherence. Primary outcomes include both adherence measures collected by the device modem at baseline and 4 months, and patient-reported outcomes such as daytime sleepiness.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • English- or Spanish-speaking
  • At least 18 years of age
  • Had previously received a modem-enabled positive airway pressure device for the treatment of sleep apnea
  • Not currently meeting Medicare standards for adherence of at least 4 hours per night for at least 70% of the last 30 nights
  • Received care from the San Francisco General Hospital Sleep Clinic

排除标准

  • Not English- or Spanish-speaking
  • Younger than 18 years
  • Does not have phone number at which could be reached

研究组 & 干预措施

Health coaching arm

Experimental

For the health coaching arm, an unlicensed, trained health coach will call patients up to five times to identify and resolve barriers to adherence, including lack of understanding of their condition or the treatment, discomfort in acclimating to treatment, technical difficulties in mask fit or device settings, and challenges in navigating durable medical equipment providers.

干预措施: Health coaching (Behavioral)

Usual care

No Intervention

Patients assigned to usual care have access to all other available resources, including technical support from durable medical equipment providers, respiratory therapist visits with the Sleep Clinic, group visits, or visits with their primary care provider.

结局指标

主要结局

Mean number of hours used on average over the last 30 days

时间窗: Enrollment to 4 months post enrollment

Total number of hours PAP device used during 30 day period divided by 30 days (PAP device is part of existing clinical care)

次要结局

  • Proportion using device at any time in last 30 days(Enrollment to 4 months post enrollment)
  • Attitudes to PAP treatment(Enrollment to 4 months post enrollment)
  • Patient-reported daytime sleepiness(Enrollment to 4 months post enrollment)
  • Confidence in using PAP therapy(Enrollment to 4 months post enrollment)
  • Mean number of hours used on average over the last 30 days on nights that device was used(Enrollment to 4 months post enrollment)
  • Mean proportion of last 30 days in which device used at least 4 hours/night(Enrollment to 4 months post enrollment)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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