ChiCTR2100050853 版本V1.0 版本创建时间2022/05/08 20:17:44 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2100050853 

最近更新日期：

Date of Last Refreshed on：

 2021-09-05 06:29:22 

注册时间：

Date of Registration：

 2021-09-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

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

Public title：

A nurse-led peer support intervention in stroke survivors

注册题目简写：

English Acronym：

研究课题的正式科学名称：

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

Scientific title：

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

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

Xiaojuan Wan 

研究负责人：

Xiaojuan Wan 

Applicant：

Xiaojuan Wan 

Study leader：

Xiaojuan Wan 

申请注册联系人电话：

Applicant telephone：

 +852 13665278059

研究负责人电话：

Study leader's
telephone：

+852 13665278059

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 xjwan@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 xjwan@link.cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

Room 604, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong, China

研究负责人通讯地址：

Room 604, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong, China

Applicant address：

Room 604, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong, China

Study leader's address：

Room 604, Esther Lee Building, The Chinese University of Hong Kong, Shatin, Hong Kong, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

香港中文大學

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

香港中文大學

Affiliation of the Leader：

The Chinese University of Hong Kong

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 2021.196-T

伦理委员会批件附件：

Approved file of Ethical Committee：

批准本研究的伦理委员会名称：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-05-21 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

香港中文大學醫學院那打素護理學院

Primary sponsor：

The Nethersole School of Nursing, The Chinese University of Hong Kong

研究实施负责（组长）单位地址：

香港中文大學醫學院那打素護理學院大樓6樓

Primary sponsor's address：

6/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, HK

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

PhD student scholarship

Source(s) of funding：

PhD student scholarship

研究疾病：

卒中  

Target disease：

stroke

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 其它 

Study phase：

N/A

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

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.  

Objectives of Study：

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.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

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

Inclusion criteria

(1) Have a clinical diagnosis of ischemic or hemorrhagic first-ever or recurrent stroke within five years prior to enrollment;
(2) More than 18 years old;
(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.

Exclusion criteria：

(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.

研究实施时间：

Study execute time：

从 From 2021-03-01 00:00:00至 To 2022-12-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-09-01 00:00:00 至 To 2022-09-01 00:00:00

干预措施：

Interventions：

组别：

intervention group

样本量：

 60

Group：

intervention group

Sample size：

干预措施：

nurse-led peer support intervention

干预措施代码：

Intervention：

nurse-led peer support intervention

Intervention code：

组别：

control group

样本量：

 60

Group：

control group

Sample size：

干预措施：

usual care

干预措施代码：

Intervention：

usual care

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 江苏 

市(区县)：

 扬州 

Country：

China

Province：

Jiangsu

City：

Yangzhou

单位(医院)：

 苏北人民医院 

单位级别：

 三甲医院 

Institution
hospital：

Subei Hospital of Jiangsu Province

Level of the institution：

Tertiary A Hospital

国家：

 中國

省(直辖市)：

 江苏 

市(区县)：

 扬州 

Country：

China

Province：

Jiangsu

City：

Yangzhou

单位(医院)：

 Wenfeng Community Health Center 

单位级别：

 社区卫生服务中心 

Institution
hospital：

Wenfeng Community Health Center

Level of the institution：

Community Health Service Center

测量指标：

Outcomes：

指标中文名：

Social participation

指标类型：

主要指标

Outcome：

Social participation

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Participation Self-efficacy

指标类型：

主要指标

Outcome：

Participation Self-efficacy

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

次要指标

Outcome：

Psychological distress

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Self-efficacy in managing chronic conditions

指标类型：

次要指标

Outcome：

Self-efficacy in managing chronic conditions

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Social support

指标类型：

次要指标

Outcome：

Social support

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Disease stigma

指标类型：

次要指标

Outcome：

Disease stigma

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

Quality of life

指标类型：

次要指标

Outcome：

Quality of life

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 岁 years
最大 Max age 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

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.

Randomization Procedure (please state who generates the random number sequence and by what method)：

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.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

Not stated

Blinding：

Not stated

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

N/A

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NA

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

NA

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-09-05 06:29:22