F@ce 2.0 - Implementation and Evaluation of a Model for a Person-centred, Information and Communication Technology and Team Based Rehabilitation Intervention for People Who Have Had Stroke in Sweden
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 18
- 主要终点
- Self-efficacy Scale
研究概览
简要总结
The purpose of the present proposal is to implement and evaluate a new model for mobile phone supported and family-centred rehabilitation intervention (F@ce 2.0) with regard to functioning in activities in daily living and participation in everyday life among persons with stroke and their families in rural and urban areas in Sweden.
详细描述
The investigators' previous feasibility study suggested beneficial effects on occupational performance and satisfaction of a mobile phone supported and person-centred rehabilitation intervention (F@ce1.0) after stroke in Stockholm, Sweden. The purpose of the present proposal is to implement and evaluate F@ce 2.0 on functioning in activities in daily living (ADL) and participation in everyday life among persons with stroke and their significant others (someone identified by the person with stroke as close i.e.partner, friend, son, daughter).
With recommendations on evaluation of complex interventions both outcomes and processes will be studied and hence both quantitative and qualitative methods will be applied. In a randomized controlled trial F@ce 2.0 will be evaluated compared to ordinary rehabilitation in urban/rural Sweden regarding; self-efficacy, perceived performance and participation in everyday activities, independence in ADL, health care utilization and the families´ perceived participation in everyday activities. Qualitative data will explore experiences of people with stroke, significant others and rehabilitation staff of participating in F@ce 2.0. The research project has a multidisciplinary perspective for sustainable rehabilitation interventions, a prerequisite for better participation in everyday life for people with stroke.
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 (Outcomes Assessor)
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
- •Persons who have had a stroke
- •Enrolled in one of the participating home rehabilitation teams in Stockholm and Dalarna
- •Able to participate in eight weeks of intervention
排除标准
- •Inability to formulate activity goals
- •Inability to express themselves in Swedish
研究组 & 干预措施
Mobile phone supported and team based rehabilitation
Participants in the intervention group will receive an 8-week mobile phone supported and team based rehabilitation intervention (F@ce 2.0)
干预措施: Mobile phone supported and team based rehabilitation (Behavioral)
Rehabilitation as usual
Control group participants will receive rehabilitation as usual and in addition information about stroke.
干预措施: Rehabilitation as usual (Behavioral)
结局指标
主要结局
Self-efficacy Scale
时间窗: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Participants are instructed to rate how confident they feel about performing each of 16 everyday activities on a 10-point rating scale ranging from 1) "not confident at all in my ability" to 10) "very confident in my ability". The average of all responses are calculated
Canadian Occupational Performance Measure (COPM)
时间窗: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Canadian Occupational Performance Measure (COPM) measures performance and satisfaction in self-care, productivity and leisure from the individual's perspective. The participant is asked 1) to rate performance of the specified activities using a 1 (low) to 10 (high) scale and 2) to score his or her satisfaction with that performance using the same scale. Weighted scores of the chosen activities are added separately for performance and satisfaction to create two summative scores. The summative scores are then divided by the number of rated activities to provide COPM scores.
Caregiver Burden Scale
时间窗: Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment
Questionnaire that consists of 22 items for different types of subjective caregiver burden, covering areas of the caregiver's health, feelings of psychological well-being, relations, social network, physical workload, and environmental aspects. The items are scored on a scale from 1 to 4 and the higher the score the greater the burden.
次要结局
- Life Satisfaction Checklist(Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment)
- Frenchay Activities Index(Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment)
- Stroke Impact Scale (SIS) 3.0(Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment)
- Fatigue Severity Scale-7(Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment)
- Hospital Anxiety and Depression Scale(Change between enrollment, after the 8 weeks of intervention and 6 months after enrollment)
研究者
Susanne Guidetti
Professor
Karolinska Institutet