ChiCTR-IOR-16008254 版本V1.1 版本创建时间2017/09/10 17:24:01 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：

 ChiCTR-IOR-16008254 

最近更新日期：

Date of Last Refreshed on：

 2017-09-10 17:23:16 

注册时间：

Date of Registration：

 2016-04-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

研究慢性心臟衰竭健康教育計劃是否能有效改善長者自我照顧心臟衰竭的能力

Public title：

Enhancing the self-care of Chinese patients with chronic heart failure

注册题目简写：

English Acronym：

研究课题的正式科学名称：

研究慢性心臟衰竭健康教育計劃是否能有效改善長者自我照顧心臟衰竭的能力

Scientific title：

Enhancing the self-care of Chinese patients with chronic heart failure: Does an empowerment-based educational model make a difference?

研究课题代号(代码)：

Study subject ID：

 CRE2015.516-T KC/KE-15-0164/ER-2

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：

CUHK_CCRB00505

申请注册联系人：

Doris, Sau-fung Yu 

研究负责人：

Doris, Sau-fung Yu 

Applicant：

Doris, Sau-fung Yu 

Study leader：

Doris, Sau-fung Yu 

申请注册联系人电话：

Applicant telephone：

 +852-39434289

研究负责人电话：

Study leader's
telephone：

+852-39434289

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：

 dyu@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 dyu@cuhk.edu.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/365

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

 https://www2.ccrb.cuhk.edu.hk/registry/public/365

申请注册联系人通讯地址：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

研究负责人通讯地址：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Applicant address：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

Study leader's address：

7/F, Esther Lee Building, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong

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：

The Nethersole School of Nurisng, Faculty of Medicine, The Chinese University of Hong Kong

Applicant's institution：

The Nethersole School of Nurisng, Faculty of Medicine, The Chinese University of Hong Kong

研究负责人所在单位：

The Nethersole School of Nurisng, Faculty of Medicine, The Chinese University of Hong Kong

Affiliation of the Leader：

The Nethersole School of Nurisng, Faculty of Medicine, 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：

 CRE2015.516-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：

Joint CUHK-NTEC Clinical Research Ethics Committee

Name of the ethic committee：

Joint CUHK-NTEC Clinical Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2015-11-10 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

伦理委员会联系地址：

Contact Address of the ethic committee：

伦理委员会联系人电话：

Contact phone of the ethic committee：

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：

HMRF

Primary sponsor：

HMRF

研究实施负责（组长）单位地址：

HMRF

Primary sponsor's address：

HMRF

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

HMRF

Source(s) of funding：

HMRF

研究疾病：

Chronic Heart Failure  

Target disease：

Chronic Heart Failure

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：

研究慢性心臟衰竭健康教育計劃是否能有效改善長者自我照顧心臟衰竭的能力  

Objectives of Study：

Enhancing the self-care of Chinese patients with chronic heart failure: Does an empowerment-based educational model make a difference?

药物成份或治疗方案详述：

For participants in intervention group, a research nurse will first assess how they take care of their disease at home and their health status. Thereafter, they will attend five weekly face-to-face sessions in small groups of 4-5 patients in the cardiac clinic. A registered nurse will guide them to set goals to improve the self-care in five areas including monitoring of bodily condition, managing the symptoms, controlling diet and fluid intake, managing the medications, and maintaining an active lifestyle. The nurse will provide the relevant health education and support them to set up plans to achieve the goals. Then, the nurse will make telephone calls to them to support them to achieve the self-care goals and give them further health advice. For participants in control group, a research nurse will first assess how they take care of their disease at home and their health status. Then, they will attend five weekly face-to-face sessions in small groups of 4-5 patients in the cardiac clinic. A registered nurse will provide them education on how to monitor bodily condition, manage the symptoms, control diet and fluid intake, manage the medications, and maintain an active lifestyle. Then, the nurse will give them telephone calls to remind them to perform the recommended self-care. 

Description for medicine or protocol of treatment in detail：

For participants in intervention group, a research nurse will first assess how they take care of their disease at home and their health status. Thereafter, they will attend five weekly face-to-face sessions in small groups of 4-5 patients in the cardiac clinic. A registered nurse will guide them to set goals to improve the self-care in five areas including monitoring of bodily condition, managing the symptoms, controlling diet and fluid intake, managing the medications, and maintaining an active lifestyle. The nurse will provide the relevant health education and support them to set up plans to achieve the goals. Then, the nurse will make telephone calls to them to support them to achieve the self-care goals and give them further health advice. For participants in control group, a research nurse will first assess how they take care of their disease at home and their health status. Then, they will attend five weekly face-to-face sessions in small groups of 4-5 patients in the cardiac clinic. A registered nurse will provide them education on how to monitor bodily condition, manage the symptoms, control diet and fluid intake, manage the medications, and maintain an active lifestyle. Then, the nurse will give them telephone calls to remind them to perform the recommended self-care. 

纳入标准：

1. Chinese people aged 55 or above;
2. Live in the community and have telephone access at home;
3. A confirmed medical diagnosis of CHF of at least 6 months standing, and with New York Heart Association Class II-IV symptoms.

Inclusion criteria

1. Chinese people aged 55 or above;
2. Live in the community and have telephone access at home;
3. A confirmed medical diagnosis of CHF of at least 6 months standing, and with New York Heart Association Class II-IV symptoms.

排除标准：

Having and impaired communication capacity or impaired cognitive function preventing participation in the programme (as indicated by and Abbreviated Test Score <=6).

Exclusion criteria：

Having and impaired communication capacity or impaired cognitive function preventing participation in the programme (as indicated by and Abbreviated Test Score <=6).

研究实施时间：

Study execute time：

从 From 1990-01-01 00:00:00至 To 1990-01-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2016-07-01 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Two groups

样本量：

 236

Group：

Two groups

Sample size：

干预措施：

The empowerment-based self-care programme versus Dialectic education, 12 weeks

干预措施代码：

Intervention：

The empowerment-based self-care programme versus Dialectic education, weeks

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

单位(医院)：

 The Chinese University of Hong Kong 

单位级别：

 The Chinese University of Hong Kong 

Institution
hospital：

The Chinese University of Hong Kong

Level of the institution：

The Chinese University of Hong Kong

测量指标：

Outcomes：

指标中文名：

Self-care maintenance and management

指标类型：

主要指标

Outcome：

Self-care maintenance and management

Type：

Primary indicator

测量时间点：

At baseline, upon completion of study intervention and 3 months thereafter.

测量方法：

Self-care heart failure index (SCFHI; Chinese version)

Measure time point of outcome：

At baseline, upon completion of study intervention and 3 months thereafter.

Measure method：

Self-care heart failure index (SCFHI; Chinese version)

指标中文名：

Self-care knowledge, self-care confidence, HRQoL

指标类型：

次要指标

Outcome：

Self-care knowledge, self-care confidence, HRQoL

Type：

Secondary indicator

测量时间点：

At baseline, upon completion of study intervention and 3 months thereafter.

测量方法：

i) Dutch Heart Failure Knowledge Scale (DHFKS; Chinese version); ii) Minnesota Living with Heart Failure Questionnaire (MLHFQ; Chinese version)

Measure time point of outcome：

At baseline, upon completion of study intervention and 3 months thereafter.

Measure method：

i) Dutch Heart Failure Knowledge Scale (DHFKS; Chinese version); ii) Minnesota Living with Heart Failure Questionnaire (MLHFQ; Chinese version)

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）：

Block randomization with a block size of 8, 10, or 12 will be used.

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

Block randomization with a block size of 8, 10, or 12 will be used.

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：

Blinding：

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）：

NA

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：

注册人：

Name of Registration：

  2016-04-09 15:43:01