【ChiCTR2100050853】Xiaojuan Wan：请与我们联系上传伦理批件 A nurse-led peer support intervention in stroke survivors

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基本信息

登记号

ChiCTR2100050853

试验状态

正在进行

药物名称

药物类型

规范名称

首次公示信息日的期

2021-09-05

临床申请受理号

靶点

适应症

卒中

试验通俗题目

Xiaojuan Wan：请与我们联系上传伦理批件 A nurse-led peer support intervention in stroke survivors

试验专业题目

Effects of a Nurse-led Peer Support Intervention on the psychosocial outcomes of stroke survivors: a randomized controlled trial

申办单位信息

申请人联系人

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申请人名称

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联系人邮箱

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联系人邮编

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临床试验信息

试验目的

To evaluate the effectiveness of the NPSI on the psychosocial outcomes of stroke survivors. Objectives: The specific objectives of this RCT are: 1. To evaluate the effectiveness of NPSI on primary outcomes (social participation, participation self-efficacy) of stroke survivors. 2. To evaluate the effectiveness of NPSI on secondary outcomes (psychological distress, self-efficacy in managing the chronic condition, social support, disease stigma, quality of life) of stroke survivors. 3. To examine the processes that underpin a group NPSI and identify the possible mediating role of social support, self-efficacy, and disease stigma in the effects of the NPSI on psychosocial outcomes.

试验分类

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试验类型

随机平行对照

试验分期

其它

随机化

the participants will be allocated randomly to the NPSI group or a control group (1:1 ratio). Blocked randomization will be used with 4 or 6 as a block. The random number sequence will be generated by a research assistant not involving in the recruitment, intervention delivery and outcome assessment.

盲法

Not stated

试验项目经费来源

PhD student scholarship

试验范围

目标入组人数

实际入组人数

第一例入组时间

2021-03-01

试验终止时间

2022-12-01

是否属于一致性

入选标准

1. Have a clinical diagnosis of ischemic or hemorrhagic first-ever or recurrent stroke within five years prior to enrollment; 2. Aged more than 18 years; 3. Able to communicate meaningfully in Mandarin and provide informed consent.；

排除标准

1. Are not medically stable or with a terminal illness; 2. Diagnosis with a mental illness; 3. Have moderate or severe cognitive impairment and cannot participate meaningfully in the workshop sessions (e.g., Mini–Mental State Examination 20) 4. Do not have the physical capacity to travel to the workshop site even with someones help; 5. Are participating in another intervention research program; 6. Do not have a reasonable expectation that they will attend a program for 2h/week for up to 6 weeks.；

研究者信息

研究负责人姓名

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试验机构

香港中文大學醫學院那打素護理學院

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研究负责人邮编

联系人通讯地址

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