Psycho-Social Well Being Following Stroke - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 322
- 试验地点
- 1
- 主要终点
- General Health Questionnaire (GHQ 28)
研究概览
简要总结
Multicenter randomized controlled trial (RCT) testing the effect of a dialogue-based psychosocial intervention for stroke acute survivors in primary care one to six months poststroke. Primary outcome is psycho-social health and wellbeing, measured by GHQ28 (primary outcome) and SAQoL (secondary outcome). 400 stroke survivors are randomized into intervention group or control group. Patients are followed up for 12 months.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •being adults (over 18 years old),
- •suffered an acute stroke within the last month,
- •medically stable,
- •sufficient cognitive functioning to participate (assessed by their physician/stroke team and acceptable Raven's score (see below),
- •interested in participating,
- •able to understand and speak Norwegian, and
- •able to give informed consent.
排除标准
- •moderate to severe dementia or other serious disease.
- •Persons with aphasia will be examined by a speech therapist and excluded if they have significant impressive aphasia or severe expressive aphasia inconsistent with participating in the dialogues.
研究组 & 干预措施
Dialogue-based psychosocial intervention
Participants receive six individual meetings with trained health care professional in additional to usual rehabilitation and care. Dialogues focus on individual psychosocial challenges and needs and provide emotional and informational support to encourage and facilitate coping.
干预措施: Dialogue-based psychosocial rehabilitation (Behavioral)
Usual care Control group
Participants receive usual rehabilitation and care.
结局指标
主要结局
General Health Questionnaire (GHQ 28)
时间窗: T2 (6 months poststroke)
28 item general scale measuring emotional distress. Four subscales (somatic symptoms, anxiety/insomnia, social dysfunction and serious depression
次要结局
- The Stroke and Aphasia Quality of Life scale (SAQOL-39)(T2 (6 months poststroke))
研究者
Marit Kirkevold
Professor
University of Oslo