Stroke - 65 Plus. Continued Active Life. (Stroke65+)
Stroke - 65 Plus. Continued Active Life. A Randomised Controlled Trial of the Effect of a Novel Self-management Intervention Supporting Older Adults After Stroke
研究概览
详细说明
Background: Elderly adults represent the majority of stroke cases worldwide. Sequelae after a stroke causes the stroke individuals to live a more isolated life 5 years after the stroke. This makes the stroke individuals an especially vulnerable group of elderly people regarding social reintegration. Reintegration into the community post-stroke depends highly on support from the family. However, the stroke individual's closest relatives are at risk of developing anxiety and depression.
The aim of this study is to investigate the effect of a novel self-management intervention supporting older adults after stroke
Methods/Design: Randomized controlled observer-blind trial. More than sixty stroke survivors over 65 years will two weeks before leaving a rehabilitation hospital be randomized to either a group receiving conventional rehabilitation (control) or a novel self-management intervention addition to standard rehabilitation.
During a period of 6 months the patients will be offered additional 6-8 sessions of self-management intervention of 45-60 minutes duration by a physiotherapist or an occupational therapist.
Study outcome measurements: Stroke Self-efficacy questionnaire, Stroke Specific Quality of Life Scale and Impact on participation and Autonomy and activity by accelerometers will be evaluated at baseline, three and nine months post hospital treatment.
Patient, informal caregiver and therapist satisfaction will be with examined with questionnaires and interviews.
Discussion: Self-management interventions are promising tools for rehabilitation of self-efficacy, quality of life as well as participation and autonomy. The introduction of novel self management intervention in combination with traditional physical and occupational therapy may enhance recovery after stroke, quality of life and burden on relatives. Stroke 65+ trial will provide further evidence of self management strategies to clinicians, patients and health economists.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Hammel、丹麦、8450
- Region Hospital Hammmel Neurorehabilitation
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Jutland
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Hammel、Jutland、丹麦、8450
- Region Hospital Hammel Neurocentre
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- stroke survivors with rehabilitation needs discharge from rehabilitation hospital to home
Exclusion Criteria:
- do not understand danish Montreal Cognitive assessment (MOCA) below 20
学习计划
研究是如何设计的?
设计细节
- 主要用途:支持治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:三倍
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Mentor
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors.
A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
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Traditional rehabilitation.
其他名称:
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有源比较器:Traditional rehabilitation
An independent centralized randomization database will provide allocation concealed to the involved clinicians and assessors.
A stratified block randomization of severity of impairment will be performed within each rehabilitation hospital
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Traditional rehabilitation.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Stroke Self-efficacy questionnaire
大体时间:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of Self-efficacy
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Impact on participation and Autonomy Questionnaire
大体时间:Measured 3 and 9 months post discharged from rehabilitation hospital
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Change of Impact on participation and Autonomy
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Measured 3 and 9 months post discharged from rehabilitation hospital
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Stroke Specific Quality of Life Scale Questionnaire(short version)
大体时间:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of Specific Quality of Life
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Activity (accelerometers)
大体时间:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of activity
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Caregiver Burden Scale
大体时间:Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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Change of caregivers burden
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Measured at baseline, 3 and 9 months post discharged from rehabilitation hospital
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合作者和调查者
调查人员
- 首席研究员:Hanne Pallesen, Post Doc、Hammel Neurorehabilitation Centre and University Research Clinic
出版物和有用的链接
一般刊物
- Pedersen SKS, Pallesen H. Stroke self-efficacy questionnaire - Denmark (SSEQ-DK): test-retest of the Danish version. Top Stroke Rehabil. 2023 Mar;30(2):193-202. doi: 10.1080/10749357.2021.2016097. Epub 2022 Jan 7.
- Sorensen SL, Pedersen SKS, Pallesen H. Social psychological mechanisms and processes in a novel, health professional-led, self-management intervention for older stroke individuals: a synthesis and phenomenological study. BMC Health Serv Res. 2019 May 22;19(1):320. doi: 10.1186/s12913-019-4150-x.
- Pallesen H, Naess-Schmidt ET, Kjeldsen SS, Pedersen SKS, Sorensen SL, Brunner I, Nielsen JF. "Stroke - 65 Plus. Continued Active Life": a study protocol for a randomized controlled cross-sectoral trial of the effect of a novel self-management intervention to support elderly people after stroke. Trials. 2018 Nov 19;19(1):639. doi: 10.1186/s13063-018-2961-4.
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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生活质量的临床试验
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Swansea University完全的
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Yale-NUS College完全的
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Scripps Translational Science Institute完全的
Mentor的临床试验
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Kinetic MusclesNational Institute of Neurological Disorders and Stroke (NINDS); The Cleveland Clinic; Emory University完全的
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Mentor Worldwide, LLC主动,不招人
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McGill UniversityRichard and Edith Strauss Foundation of Canada完全的