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临床试验/NCT02289287
NCT02289287终止不适用

Effects of a Self-Management Group-Intervention on Participation in Post-Stroke Patients.

Uzi Milman1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年4月17日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
60
试验地点
1
主要终点
Patient Participation

研究概览

简要总结

Stroke is defined as a sudden vascular accident that causes brain damage and neurological impairment. Literature shows that a stroke has a negative effect on participation. Self-Management (SM) is defined as health promotion and education programs used mostly for people with chronic diseases, which aim at helping patients to maintain a feeling of wellness. The primary aim of this study is to assess the effectiveness of a group-based SM program for post-stroke patients in a community setting, and its contribution to improving participation, compared to standard care.

详细描述

At enrollment eligible patients will be randomized to Intervention + Standard Care or Standard Care group. Within 3 weeks after enrollment all participants will undergo baseline assessment using a predefined set of scales and questionnaires (intervention group will additionally undergo a semi-structured interview). The group-intervention (SM program) will begin after enrollment of at least 4 participants to the intervention group, and within no longer than 5 weeks since enrollment. The intervention will include 12 weekly sessions, each session 2.5 hour long, and will be based on well-known SM interventions that were found effective for stroke patients in the U.S. Standard care will include 'one-on-one' sessions in each paramedical discipline as given regularly in this setting (average of 15-20 sessions per patient). Follow-up measures will be performed within a week after the end of the intervention, and 6 months thereafter, in order to examine long term effectiveness. Outcome measures are questionnaires; change will be assessed by the difference in total score between T1 |(pre-intervention), T2 (post-intervention) and T3 (after 6 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 (Outcomes Assessor)

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cerebrovascular accident diagnosed 3-18 months before enrollment. Treated at th Neurologic Rehabilitation Center of Clalit Health Services in Kiryat Byalik, Israel.
  • Living in the community (in their homes). Are capable of basic communication in Hebrew.

排除标准

  • Moderate-severe stroke (National Institutes of Health Stroke Scale (NIHSS) score ≤ 16).
  • Moderate-Severe Cognitive impairment (Montreal Cognitive Assessment (MOCA) - total score ≤ 16). Inability to provide informed consent.

研究组 & 干预措施

Self-Management group-intervention

Experimental

Participants will receive Self-Management group-intervention + Standard Care

干预措施: Self-Management group-intervention (Behavioral)

Standard Care

Active Comparator

Participants will receive Standard Care only

干预措施: Standard Care (Behavioral)

结局指标

主要结局

Patient Participation

时间窗: 12 and 36 weeks

The primary outcome measure is the change in patient's participation, as defined by the International Classification of Function, Disability and Health (ICF), between the three assessment points - baseline, 12 and 36 weeks.

次要结局

  • Self-efficacy for self-management behaviors.(12 and 36 weeks)

研究者

发起方
Uzi Milman
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Uzi Milman

Director, Clinical Research Unit, Clalit Health Services, Haifa and Western Galilee District and the Department of Family Medicine, Faculty of Medicine, Technion- Israel Institute of Technology, HAIFA, ISRAEL

Clalit Health Services

研究点 (1)

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