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临床试验/NCT00495248
NCT00495248Unknown1 期

Well-being, Activity and Social Participation After Stroke/TIA. RCT-psycho Social Intervention Study.

Ullevaal University Hospital2 个研究点 分布在 1 个国家目标入组 140 人开始时间: 2007年1月1日最近更新:
适应症

试验速览

阶段
1 期
发起方
入组人数
140
试验地点
2
主要终点
SF-36

研究概览

简要总结

The aim of the study is to evaluate the effect of a group intervention programme for community dwelling elders with stroke or TIA.The intervention is inspired by a Lifestyle Redesign method developed in the USA. The study is conducted as a multi centre randomized controlled trial. Participants are recruited from five hospitals and the intervention is implemented at six to seven senior centres. The control group is offered physical activity at the senior centre once a week. The intervention group is offered the same with addition of the programme inspired by Lifestyle Redesign. The study will contribute to knowledge whether the intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or TIA.

详细描述

Stroke is a common disease among older people. In Norway 60-70 000 people live with sequela after stroke. Depressive symptoms, anxiety and social isolation are occurring among 20 to 60 percent. Little is known about intervention for people with mild neurological symptoms who simultaneously perceive social isolation, depression and reduced satisfaction in their daily life after stroke. Lifestyle redesign (LR) is developed in the USA and is a health promoting group intervention programme with focus on the participants' exchange of experiences and involvement. The aim of the study is to evaluate the effect on thriving, activity and social participation of a group intervention program inspired by Lifestyle redesign for community dwelling persons with stroke. The study is conducted as a multicentre randomized controlled trial. Participants are recruited from five hospitals and the intervention is carried through at six to seven senior centres. The control group is offered a physical activity programme at the senior centre once a week. The intervention group is offered the same with the additional intervention programme also once a week. The study will contribute to knowledge whether this group intervention will promote social participation and thriving in daily life and prevent social isolation and depressive symptoms among community dwelling elders with stroke or TIA.

研究设计

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

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

  • oral and written consent
  • clinical stroke ref WHO definition
  • home-dwelling previous to stroke
  • home-service less than twice a week previous to stroke
  • Barthel ADL-index >14 of 20
  • MMS >23 of 30
  • be able to communicate evaluated by Ulleval aphasia screening test

排除标准

  • reduced consent
  • severe disease
  • clinical contradictions evaluated by the responsible physician

结局指标

主要结局

SF-36

时间窗: Approximately 3 months after stroke-BASELINE, after 6 and 9 months

次要结局

  • Hospital Anxiety Depression Scale (HAD), Canadian Occupational Performance Measure (COPM), Trail making A and B, Timed up and go (TUG)(Approximately 3 months after stroke-BASELINE, after 6 and 9 months)

研究者

发起方
Ullevaal University Hospital
申办方类型
Other

研究点 (2)

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