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临床试验/NCT03837249
NCT03837249已完成早期 1 期

Self-Management of Sleep Among Older Adults Using Personal Monitoring: A Feasibility Study

University of Massachusetts, Amherst2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2019年2月4日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
已完成
入组人数
26
试验地点
2
主要终点
Use of A Personal Sleep Monitoring Device (PSMD)

研究概览

简要总结

The purpose of this study is to test the feasibility of older persons use of a personal sleep monitoring device(PSMD)to improve self-management of sleep. Disrupted sleep occurs in up to 50% of persons over the age of 65 with chronic health conditions. Impaired sleep negatively influences subjective and objective health outcomes.To improve their sleep, older adults with chronic health conditions could benefit from objective information, available through personal health monitoring devices, about their current and changing sleep patterns. Based on this information, sleep self-management interventions can be individualized and shared, and associations between sleep and health changes may be better managed.

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
Single (Participant)

盲法说明

One group - personal sleep monitoring data with-held then provided after the intervention period.

入排标准

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

入选标准

  • 65 years or older
  • Self-report difficulty sleeping
  • Willingness to wear the PSMD for four weeks
  • Cognitive abilities (Mini Cog of 5 or above).

排除标准

  • Under the age of 65
  • Presence of known sleep disorders
  • Severe cognitive or neurosensory impairment

结局指标

主要结局

Use of A Personal Sleep Monitoring Device (PSMD)

时间窗: up to 4 weeks

Demonstrates use of Personal Sleep Self-Monitor through data downloads and self-report

Changes in Sleep

时间窗: Week 1 and Week 4

Demonstrated sleep changes indicated by change in BRCS NINR PROMIS SF V1 Sleep Disturbance Scale 6a (a 6 item, 5 point likert scale with higher scores reflecting more sleep disturbance and lower scores less.

Changes in Health

时间窗: Week 1 and Week 4

Demonstrated health changes indicated by change in BRCS NINR PROMIS Global Health Short Form Scale 10a (10 item, 5 point likert scale) with higher scores reflecting better health (3 items reverse scoring)

次要结局

  • Usability of PSMD(Week 2 and 4)

研究者

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

Raeann G LeBlanc

Assistant Clinical Professor

University of Massachusetts, Amherst

研究点 (2)

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