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促進多重長期疾病患者的護理研究計劃
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注册号：

Registration number：

 ChiCTR-OIC-16008477 

最近更新日期：

Date of Last Refreshed on：

 2018-07-29 10:23:26 

注册时间：

Date of Registration：

 2016-05-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

促進多重長期疾病患者的護理研究計劃

Public title：

The Community Primary Care Programme: Enhancing care of people with complex chronic conditions

注册题目简写：

English Acronym：

研究课题的正式科学名称：

促進多重長期疾病患者的護理研究計劃

Scientific title：

The Efficacy of Complex Integrated Community Primary Care Programme in People with Complex Chronic Conditions

研究课题代号(代码)：

Study subject ID：

 CREC 2016.204

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_CCRB00512

申请注册联系人：

Wing Yin TAM 

研究负责人：

Samuel Yeung-shan WONG 

Applicant：

Wing Yin TAM 

Study leader：

Samuel Yeung-shan WONG 

申请注册联系人电话：

Applicant telephone：

 +852 25039053

研究负责人电话：

Study leader's
telephone：

+852 2252-8774

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：

 wingyintam@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 yeungshanwong@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/373

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/373

申请注册联系人通讯地址：

Room 04, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin

研究负责人通讯地址：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, New Territories, Hong Kong

Applicant address：

Room 04, 4/F, Lek Yuen Health Centre, 9 Lek Yuen Street, Shatin

Study leader's address：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, New Territories, 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 Chinese University of Hong Kong

Applicant's institution：

The Chinese University of Hong Kong

研究负责人所在单位：

The Chinese University of Hong Kong

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：

 2016.204

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：

 2016-04-28 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：

Professor Samuel Yeung-shan WONG

Primary sponsor：

Professor Samuel Yeung-shan WONG

研究实施负责（组长）单位地址：

Professor Samuel Yeung-shan WONG

Primary sponsor's address：

Professor Samuel Yeung-shan WONG

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Hong Kong Jockey Club Charities Trust

Source(s) of funding：

Hong Kong Jockey Club Charities Trust

研究疾病：

多重長期疾病患者  

Target disease：

people with complex chronic conditions

研究疾病代码：

Target disease code：

研究类型：

观察性研究

Study type：

Observational study

研究所处阶段：

 II期临床试验 

Study phase：

2

研究设计：

单臂 

Study design：

Single arm 

研究目的：

促進多重長期疾病患者的護理  

Objectives of Study：

Enhancing care of people with complex chronic conditions

药物成份或治疗方案详述：

Description/ name of Intervention/article: For those who are eligible for the case clinic, they will be seen by a case management professional (a social worker/nurse) and a management plan will be made and the medical and psycho-social needs will be addressed with input from the multidisciplinary team members including the participating NGOs. For all patients enrolled, baseline assessments and subsequent outcome and process evaluations of health related indicators will be measured by the project coordinator regularly to monitor the quality and progress of the programme. For these patients, a complex integrated primary care programme with three components will be provided: 1) Family members/carers resilience and support programme including a) support group interventions e.g. connecting existing network and resources and online group discussion and webpage modules; b) professional education interventions such as behavioral management, self enhancement skills and chronic disease education; 2) Patients empowerment programme including a) self-management programme b) transformative learning and c) socialization to build up partnership between individuals and illness, family, carers and health professionals and 3) Direct Intervention on family members or patients: counseling/therapy intervention targeted on specific treatment needs and home visits to help patients with specific health or social needs. Assessment and progress monitoring will be carried on month 0 and month 24. 

Description for medicine or protocol of treatment in detail：

Description/ name of Intervention/article: For those who are eligible for the case clinic, they will be seen by a case management professional (a social worker/nurse) and a management plan will be made and the medical and psycho-social needs will be addressed with input from the multidisciplinary team members including the participating NGOs. For all patients enrolled, baseline assessments and subsequent outcome and process evaluations of health related indicators will be measured by the project coordinator regularly to monitor the quality and progress of the programme. For these patients, a complex integrated primary care programme with three components will be provided: 1) Family members/carers resilience and support programme including a) support group interventions e.g. connecting existing network and resources and online group discussion and webpage modules; b) professional education interventions such as behavioral management, self enhancement skills and chronic disease education; 2) Patients empowerment programme including a) self-management programme b) transformative learning and c) socialization to build up partnership between individuals and illness, family, carers and health professionals and 3) Direct Intervention on family members or patients: counseling/therapy intervention targeted on specific treatment needs and home visits to help patients with specific health or social needs. Assessment and progress monitoring will be carried on month 0 and month 24. 

纳入标准：

Inclusion criteria

排除标准：

1) Cognitive impairment with MMSE score less than 18;
2) Immobility. Confined to a bed or chair for > 22 hours per day; for at least 4 of the past 7days;
3) Lacking capacity of consent.

Exclusion criteria：

1) Cognitive impairment with MMSE score less than 18;
2) Immobility. Confined to a bed or chair for > 22 hours per day; for at least 4 of the past 7days;
3) Lacking capacity of consent.

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 2016-05-23 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

Case series

样本量：

 1000

Group：

Case series

Sample size：

干预措施：

Complex Integrated Community Primary Care Programme

干预措施代码：

Intervention：

Complex Integrated Community Primary Care Programme

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：

The change of EQ5D5L from baseline to the end of month 24

指标类型：

主要指标

Outcome：

The change of EQ5D5L from baseline to the end of month 24

Type：

Primary indicator

测量时间点：

Month 0 and month 24.

测量方法：

EQ5D5L questionnaire

Measure time point of outcome：

Month 0 and month 24.

Measure method：

EQ5D5L questionnaire

指标中文名：

Change of lifestyle (e.g. physical activities level, smoking, alcohol consumption)

指标类型：

次要指标

Outcome：

Change of lifestyle (e.g. physical activities level, smoking, alcohol consumption)

Type：

Secondary indicator

测量时间点：

Month 0 and month 24.

测量方法：

Physical activities level will be assessed by International Physical Activity Questionnaire. Smoking and alcohol consumption habit will be recorded by history taking and AUDIT-C questionnaire.

Measure time point of outcome：

Month 0 and month 24.

Measure method：

Physical activities level will be assessed by International Physical Activity Questionnaire. Smoking and alcohol consumption habit will be recorded by history taking and AUDIT-C questionnaire.

指标中文名：

Change of health parameters (eg, blood pressure, pain assessment and body mass index (BMI),

指标类型：

次要指标

Outcome：

Change of health parameters (eg, blood pressure, pain assessment and body mass index (BMI),

Type：

Secondary indicator

测量时间点：

Month 0 and month 24.

测量方法：

Blood pressure data will be collected by blood pressure monitor, pain assessment will be done by Brief Pain Inventory, Body mass index will be calculated by the formula: Body weight/(Body Height x Body Height)

Measure time point of outcome：

Month 0 and month 24.

Measure method：

Blood pressure data will be collected by blood pressure monitor, pain assessment will be done by Brief Pain Inventory, Body mass index will be calculated by the formula: Body weight/(Body Height x Body Height)

指标中文名：

Change of health service utilization pattern (having a family doctor, self-care, use of public primary care clinics (ie, the general outpatient clinic (GOPC)) and accident and emergency service)

指标类型：

次要指标

Outcome：

Change of health service utilization pattern (having a family doctor, self-care, use of public primary care clinics (ie, the general outpatient clinic (GOPC)) and accident and emergency service)

Type：

Secondary indicator

测量时间点：

Month 0 and month 24.

测量方法：

Change of health service utilization pattern will be recorded by history taking

Measure time point of outcome：

Month 0 and month 24.

Measure method：

Change of health service utilization pattern will be recorded by history taking

指标中文名：

Change of psychosoical health (e.g. anxiety, depression, social support, loneliness level and meaningfulness in life),

指标类型：

次要指标

Outcome：

Change of psychosoical health (e.g. anxiety, depression, social support, loneliness level and meaningfulness in life),

Type：

Secondary indicator

测量时间点：

Month 0 and month 24.

测量方法：

Anxiety level will be assessed by GAD-7 questionnaire, Depression level will be assessed by PHQ-9, social support can be measured by MSPSS questionnaire, loneliness level can be measured by 6-item De Jong Gierveld Loneliness Scale and meaningfulness of life will be assessed by the C-MLQ.

Measure time point of outcome：

Month 0 and month 24.

Measure method：

Anxiety level will be assessed by GAD-7 questionnaire, Depression level will be assessed by PHQ-9, social support can be measured by MSPSS questionnaire, loneliness level can be measured by 6-item De Jong Gierveld Loneliness Scale and meaningfulness of life will be assessed by the C-MLQ.

指标中文名：

Change of self care ability, cognitive assessment and habit of seeking health information

指标类型：

次要指标

Outcome：

Change of self care ability, cognitive assessment and habit of seeking health information

Type：

Secondary indicator

测量时间点：

Month 0 and month 24.

测量方法：

Self care ability will be assessed by IADL questionnaire, cognitive assessment will be done by MMSE questionnaire and habit of seeking health information will be done by eHEALS questionnaire and a social media utilization questionnaire

Measure time point of outcome：

Month 0 and month 24.

Measure method：

Self care ability will be assessed by IADL questionnaire, cognitive assessment will be done by MMSE questionnaire and habit of seeking health information will be done by eHEALS questionnaire and a social media utilization questionnaire

采集人体标本：

Collecting sample(s)
from participants：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 60 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）：

NA

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

NA

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：

有/Yes

注册人：

Name of Registration：

  2016-05-15 22:13:58
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