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临床试验/NCT04372329
NCT04372329已完成不适用

A Tailored Sleep Behavior Change Support System to Promote the Use of Continuous Positive Airway Pressure Therapy: Theorizing the Solution

Sarah Alismail1 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2020年7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
发起方
入组人数
59
试验地点
1
主要终点
CPAP compliance

研究概览

简要总结

Obstructive sleep apnea (OSA) is the most common sleep breathing disorder in the U.S. Continuous Positive Airway Pressure (CPAP) therapy is the most effective treatment for OSA. However, up to 50% of patients who accept using CPAP therapy fail to adhere to it. This study will evaluate an information systems (IS)-based solution that sends tailored, motivational, educational messages and tailored feedback messages to promote CPAP usage among noncompliant OSA patients. The primary aim of this study is to determine the efficacy of the proposed IS solution and its effect on fostering the use of CPAP therapy among OSA patients.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
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
否

入选标准

  • •Clinical diagnosis of OSA
  • •Prescribed treatment of CPAP therapy
  • •Possession of a mobile phone that has multimedia messaging capabilities
  • •Capacity to consent.

排除标准

  • •Unable to speak and read English

研究组 & 干预措施

CPAP4HealthySleep: System 1 (ABAB)

Experimental

Participants in this group will first receive six tailored educational messages per week and weekly feedback messages notifying participants of their CPAP usage on the seventh day for two weeks (type A). Next, they will receive weekly feedback messages only (one message per week) notifying participants of their CPAP usage for two weeks (type B), re-introduction of type A for another two weeks, followed by re-introduction of type B for two weeks.

干预措施: CPAP4HealthySleep system (Behavioral)

CPAP4HealthySleep: System 2 (BABA)

Experimental

Participants in this group will first receive weekly feedback messages only (one message per week) notifying participants of their CPAP usage for two weeks (type B). Next, they will receive six tailored educational messages per week and weekly feedback messages notifying participants of their CPAP usage on the seventh day for two weeks (type A), re-introduction of type B for another two weeks, followed by re-introduction of type A for two weeks.

干预措施: CPAP4HealthySleep system (Behavioral)

结局指标

主要结局

CPAP compliance

时间窗: 19 weeks

Compliance of CPAP use characterized by mask-on time at the prescribed pressure for ≥ 4 hours/day for 70% of monitored nights.

Change in CPAP usage

时间窗: During 19 weeks

The average number of hours per week of CPAP usage.

次要结局

未报告次要终点

研究者

发起方
Sarah Alismail
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Sarah Alismail

Principle Investigator

Claremont Graduate University

研究点 (1)

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