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