跳至主要内容
临床试验/NCT00662623
NCT00662623已完成2 期

Enabling Sleep Apnea Patient-Centered Care Via an Internet Intervention

Veterans Medical Research Foundation2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2008年4月1日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
200
试验地点
2
主要终点
CPAP Adherence

研究概览

简要总结

The purpose of this study is to examine the effect of different methods of providing education about sleep apnea and continuous positive airway pressure therapy (CPAP) use and how that education might help to improve health outcomes and the amount of time CPAP is used.

详细描述

Poor treatment adherence with CPAP therapy is well-documented. Set against a backdrop of telemedicine applications that have grown as fast in unsubstantiated claims and assumptions of patient satisfaction, diagnostic accuracy, clinical efficacy, and cost-effectiveness as they have in technological sophistication and capabilities, the evaluative aspect of this proposal is designed as as a randomized, controlled clinical trial-Usual Care patients (control) versus i-PAP patients (intervention). An important empirical-methodological advantage of the project is the objective measurement of CPAP adherence, which is measured by internal microprocessor as the "amount of time CPAP is used at the prescribed pressure." This objective measurement allows feedback of treatment adherence and efficacy to both patient and provider, and the i-PAP intervention was designed around this central feature.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • age > 18 years
  • confirmed diagnosis of OSA
  • being newly prescribed CPAP therapy
  • having chronic symptoms as noted on screening symptom checklist
  • fluency in English

排除标准

  • cognitive impairment sufficient to cause inability to complete the protocol (MMSE < 24/30)
  • residence in a geographical area outside of San Diego County
  • fatal comorbidity (life expectancy less than 6 months as indicated by treating physician)
  • significant documented substance/chemical abuse or other participant circumstances that, in the opinion of a consensus of study team, would interfere with the safety of a prospective participant or their need for treatment

结局指标

主要结局

CPAP Adherence

时间窗: 4 months

次要结局

  • Quality of patient-centered collaborative care(4 months)

研究者

发起方
Veterans Medical Research Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Carl J. Stepnowsky

Study PI

Veterans Medical Research Foundation

研究点 (2)

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