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临床试验/NCT04727619
NCT04727619进行中(未招募)不适用

Sleep Education for Elders Program Evaluation

Michigan State University1 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2021年2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
进行中(未招募)
入组人数
210
试验地点
1
主要终点
Insomnia symptoms

研究概览

简要总结

This study tests the effectiveness of a new educational intervention designed to improve sleep outcomes among an older adult population.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

盲法说明

Analyses will be done by blinded assessor.

入排标准

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

入选标准

  • •participants who choose to enroll in the SLEEP program

排除标准

  • •younger than 40 years of age

研究组 & 干预措施

Experimental

Experimental

Participants who participated in the SLEEP program.

干预措施: SLEEP program (Behavioral)

Control

No Intervention

Participants who did not participate in the SLEEP program.

结局指标

主要结局

Insomnia symptoms

时间窗: Six months after program completion

As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.

Sleep hygiene habits

时间窗: Six months after program completion

As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.

Sleep quality: Pittsburgh Sleep Quality Index

时间窗: Six months after program completion

Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.

Sleep duration

时间窗: Six months after program completion

Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index

Daytime sleepiness

时间窗: Six months after program completion

Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.

Sleep quality: Pittsburgh Sleep Quality Index

时间窗: immediately after the program

Change in sleep quality as measured by Pittsburgh Sleep Quality Index. Scores range from 0-21 with higher scores representing worse outcomes.

Sleep duration

时间窗: immediately after the program

Change in sleep duration (hours and minutes) as measured by Pittsburgh Sleep Quality Index

Daytime sleepiness

时间窗: immediately after the program

Change in daytime sleepiness measured by Epworth Sleepiness Scale. Scale scoring ranges from 0-24, with higher scores indicating worse outcomes.

Insomnia symptoms

时间窗: immediately after the program and six months later

As measured by Insomnia Severity Index. Scores range from 0-28 with higher scores indicating worse outcomes.

Sleep hygiene habits

时间窗: immediately after the program

As measured by Sleep Hygiene Index. Scores range from 0-52 with higher scores indicating worse outcomes.

次要结局

  • Program satisfaction: questions and comments related to program experiences(six months later)
  • Sleep-related knowledge(six months later)
  • Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration(six months later)
  • Sleep-related knowledge(immediately after the program)
  • Sleep satisfaction: questions measuring personal satisfaction with sleep quality and duration(immediately after the program)
  • Program satisfaction: questions and comments related to program experiences(immediately after the program)

研究者

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

Robin Tucker

Assistant Professor

Michigan State University

研究点 (1)

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