Supporting Daily Functioning of Persons With a Neurological Disorder: (Cost)Effectiveness of Occupational Therapy at Home E-Rehabilitation (OTHER) for Persons Post-stroke
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 18
- 主要终点
- Changes in Canadian Occupational Performance measure (COPM-p) at three time points
研究概览
简要总结
The goal of this (cost)effectiveness study is to compare care as usual with OTHER-intervention in Cerebro Vascular Accident (CVA) older adults in Geriatric Rehabilitation (GR). The main question[s] it aims to answer are:
- What is the effectiveness of OTHER, as compared to occupational therapy as usual (CAU), on improving the self-perceived performance in daily activities of community-dwelling older persons post-stroke over a 24-week period after initiation of OTHER or CAU, as measured longitudinally (at week 4, 13 and 26)?
Secondary: 2. What is the effectiveness of OTHER on improving satisfaction with the perceived daily performance of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) 3. What is the effectiveness of OTHER on improving physical activity of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) 4. What is the effectiveness of OTHER on improving self-management of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach) 5. How do persons post-stroke and OT's experience and how do they reflect on OTHER in supporting a sense of self-management, safety and improving daily functioning? (qualitative approach). 6. What factors influenced the intervention delivery and the perceived benefits in the OTHER study (process evaluation)? 1) monitoring treatment fidelity, barriers and facilitators for implementation; 2) gain insight into the impact of OTHER on the GR transition to home; 3) to gain insight into what stroke survivors and OT's think of OTHER. 4) how participants, and professionals experience and thoughts they have on the OTHER-intervention in supporting daily functioning and self-management
Cost-effectiveness 7. What is the cost-effectiveness of OTHER on improving self-perceived performance in daily activities and Quality Adjusted Life Years (QALYs) of community-dwelling persons post-stroke, 26 weeks after start compared to usual OT? (quantitative approach)
Participants will get the OTHER-intervention treatment given by de occupational therapist which consists of activity monitoring, coaching and videoconferencing to optimalise the transition from clinical care to home.
Researchers will compare care as usual to see if there is a effect on improving the self-perceived performance in daily activities, self-management and improving physical activity .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be able to walk a few steps with or without a walking device.
- •60 years or older
- •an assessment score of at least 16 on the Montreal Cognitive Assessment (MoCA)
- •an indication for follow up GR at home
排除标准
- •Who are terminally ill
- •Who have severe aphasia; problems with understanding.
- •Who has been assessed legally incapable by a geriatric doctor
研究组 & 干预措施
Care as usual
Care as usual, consist of GR rehabilitation when a patient is back at home.
OTHER-intervention
The OTHER-intervention is part of the OT care. Start during inpatient GR rehabilitation and goes on 12 weeks after discharge when a patient is home or starts after discharge from hospital going home. The OT will coach a patient and use a activity monitoring system. Also videoconferencing will be used.
干预措施: OTHER-intervention (Occupational Therapy at Home E-Rehabilitation) (Other)
结局指标
主要结局
Changes in Canadian Occupational Performance measure (COPM-p) at three time points
时间窗: The investigators assess the changes across three time points (one, three and six months)
The primary outcome measure is 'perceived daily performance' 4 weeks, 12 weeks and 24 weeks after the start of OTHER compared to baseline functioning, measured with the Canadian Occupational Performance measure. The COPM results in a performance score (COPM-p). The COPM is a person-centred, occupation-focused outcome measure for the detection of change in perceived daily performance over time. The COPM results in a performance score (COPM-p) and a satisfaction score (COPM-s). Through a semi-structured interview, persons will prioritize up to five daily activities that deemed most important and rate each on a 10-point scale regarding perceived performance (COPM-p) (1=not able to do at all and 10 = able to do extremely well. The mean COPM-p will be obtained by summing the ratings and dividing them by the number of prioritized activities.
次要结局
- Activity level(up to 15 weeks)
- Changes in Canadian Occupational Performance measure (COPM-s)(baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR)
- Self-management(baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR)
- Patient's quality of life.(baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR)
- Capability of older people(baseline,4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR)
- Mobility functioning(baseline and 24 weeks after discharge GR)
- Satisfaction with OT(baseline, 4 weeks after discharge GR, 12 weeks after discharge GR and 24 weeks after discharge GR)
- Societal cost(12 weeks after discharge GR and 24 weeks after discharge GR)
研究者
Sanne Pellegrom
MSc. of Health Science - Principal Investigator
Amsterdam University of Applied Sciences