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临床试验/NCT01358032
NCT01358032已完成不适用

Evaluating the Effectiveness of an In-home Self-management Intervention to Prevent Psychological Distress in Frail Older People Living in the Community

Maastricht University Medical Center1 个研究点 分布在 1 个国家目标入组 389 人开始时间: 2009年3月1日最近更新:
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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
389
试验地点
1
主要终点
concerns about falling
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The main objectives of this study are:

  1. an effect evaluation of an in-home multicomponent cognitive behavioural program on concerns about falling and related avoidance of activity (primary outcomes), as well as disability, fall incidents (secondary outcomes) and several additional outcomes in frail community-dwelling older people,
  2. a process evaluation of the feasibility of the program, with the following main outcomes: population reached, performance according to protocol, exposure and engagement, opinion on the program of participants and facilitators, perceived benefit or achievement, and experienced barriers and potential solutions, and
  3. an economical evaluation on the impact of the program on healthcare utilization and related costs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • •Aged 70 years or over
  • •At least some concerns about falling
  • •At least some associated avoidance of activity
  • •Fair or poor perceived general health
  • •Living independently in the community
  • •Written informed consent

排除标准

  • •Cognitive impairment (a score of less than 4 on the Abbreviated Mental Test 4)
  • •Language or hearing problems that impede completing an interview by telephone
  • •Sight problems that impede completing the intervention
  • •Confinement to bed
  • •Waiting for nursing home admission
  • •Permanent use of a wheelchair

研究组 & 干预措施

Cognitive behavioral program

Experimental

an in-home cognitive behavioral program on managing concerns about falling and associated activity avoidance in frail community-dwelling older people facilitated by trained community nurses.

干预措施: an in-home cognitive behavioral program (Behavioral)

Control group

No Intervention

no program, only care as usual

结局指标

主要结局

concerns about falling

时间窗: baseline, 5 months and 12 months

Falls Efficacy Scale International (FES-I)

avoidance of activities due concerns about falling

时间窗: baseline, 5 months and 12 months

Falls Efficacy Scale International Avoidance Behaviour (FES-IAB)

次要结局

  • disability(baseline, 5 months and 12 months)
  • number of falls(continuous registration during the course of the trial for a period of 1 year)
  • catastrophic beliefs about falling(baseline, 5 months and 12 months)
  • perceived consequences of falling(baseline, 5 months and 12 months)
  • perceived control over falling(baseline, 5 months and 12 months)
  • mastery(baseline, 5 months and 12 months)
  • feelings of anxiety(baseline, 5 months and 12 months)
  • symptoms of depression(baseline, 5 months and 12 months)
  • social support interactions(baseline, 5 months and 12 months)
  • health-related quality of life(baseline, 5 months and 12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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