ChiCTR1800017414 版本V1.0 版本创建时间2019/10/07 22:20:40 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：

ChiCTR1800017414 

最近更新日期：

Date of Last Refreshed on：

2018-07-29 10:09:19 

注册时间：

Date of Registration：

2018-07-09 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

動機式訪談法對社區糖尿病人影響之先導性隨機控制試驗

Public title：

Impact of Motivational Interviewing on the management of diabetic patients in the community: a pilot randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

動機式訪談法對社區糖尿病人影響之先導性隨機控制試驗

Scientific title：

Impact of Motivational Interviewing on the management of diabetic patients in the community: a pilot 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：

CUHK_CCRB00614

申请注册联系人：

Man Kin Wong 

研究负责人：

Man Kin Wong 

Applicant：

Man Kin Wong 

Study leader：

Man Kin Wong 

申请注册联系人电话：

Applicant telephone：

+852 24685111

研究负责人电话：

Study leader's telephone：

+852 24685111

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：

wmk902@ha.org.hk

研究负责人电子邮件：

Study leader's E-mail：

wmk902@ha.org.hk

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

https://www2.ccrb.cuhk.edu.hk/registry/public/522

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/522

申请注册联系人通讯地址：

Madam Yung Fung Shee Health Center, 26 Sai Ching Street, Yuen Long, Hong Kong, China

研究负责人通讯地址：

Madam Yung Fung Shee Health Center, 26 Sai Ching Street, Yuen Long, Hong Kong, China

Applicant address：

Madam Yung Fung Shee Health Center, 26 Sai Ching Street, Yuen Long, Hong Kong, China

Study leader's address：

Madam Yung Fung Shee Health Center, 26 Sai Ching Street, Yuen Long, 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：

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

Applicant's institution：

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

研究负责人所在单位：

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

Affiliation of the Leader：

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

NTWC/CREC/18038

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：

New Territories West Cluster Research Ethics Committee

Name of the ethic committee：

New Territories West Cluster Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2018-07-03 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：

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

Primary sponsor：

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

研究实施负责（组长）单位地址：

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

Primary sponsor's address：

Family Medicine and Primary Health Care, New Territories West Cluster, Hospital Authority

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 College of Family Physician

Source(s) of funding：

Hong Kong College of Family Physician

Target disease：

Diabetes

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 卫生服务研究 

Study phase：

Health Services Research

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

動機式訪談法對社區糖尿病人影響  

Objectives of Study：

Impact of Motivational Interviewing on the management of diabetic patients in the community

药物成份或治疗方案详述：

The theoretical approach of the intervention is based on self-efficacy theory and MI spirit. Perceived self-efficacy is defined as people’s beliefs about their capabilities of producing designated levels of performance exercising influence over events that affect their lives. MI is used as a method to facilitate this process. MI is a directive counselling style for eliciting behaviour change by helping patients to explore and resolve ambivalence. In addition to usual care, patients in the intervention group received a 1 year MI programme consisting of up to five individual counselling sessions lasting approximately 30-45 min. Each participant in the intervention group will be assigned an advanced practice nurse (APN) who has received trained in MI. The style of the interview is standardized with the following components: (1) seeking to understand the person’s frame of reference; (2) expressing acceptance and affirmation; (3) eliciting and selectively reinforcing the client’s own self-motivational statements of problem recognition, concern, desire and intention to change, and ability to change; (4) exploring the client’s degree of readiness to change; and (5) affirming the client’s freedom of choice and self-direction. The role of exploring readiness to change is that this is used as a component of the therapeutic process and not an outcome. Each session followed a semi-structured interview format of MI, especially developed for this intervention programme. Participants may bring up any issues of their concern related to diabetes self-care during the intervention sessions. The participants in the intervention group may be referred by the healthcare professional to individual counselling in lifestyle modification As deemed necessary by the personnel, and these include dietary changes, promotion of physical activity, as well as counseling on smoking and alcohol habits. Control group: Medical treatment is not part of the intervention. All participants, irrespective of participation in the intervention group or the control group, will undergo the same routine check-up at GOPD in charge of their diabetes care. Biochemical tests and examinations will be performed during the visits in accordance with protocols. Individual counselling and recommendations based on the results of the examinations, biochemical tests and their self-monitoring of blood glucose will be given. Renewal of prescribed medication will be done at these check-up visits. Patients could be referred for individual counselling including diet modification, optimization of physical activity, smoking cessation if applicable, and minimization of alcohol use if required by their usual healthcare provider. 

Description for medicine or protocol of treatment in detail：

The theoretical approach of the intervention is based on self-efficacy theory and MI spirit. Perceived self-efficacy is defined as peoples beliefs about their capabilities of producing designated levels of performance exercising influence over events that affect their lives. MI is used as a method to facilitate this process. MI is a directive counselling style for eliciting behaviour change by helping patients to explore and resolve ambivalence. In addition to usual care, patients in the intervention group received a 1 year MI programme consisting of up to five individual counselling sessions lasting approximately 30-45 min. Each participant in the intervention group will be assigned an advanced practice nurse (APN) who has received trained in MI. The style of the interview is standardized with the following components: (1) seeking to understand the persons frame of reference; (2) expressing acceptance and affirmation; (3) eliciting and selectively reinforcing the clients own self-motivational statements of problem recognition, concern, desire and intention to change, and ability to change; (4) exploring the clients degree of readiness to change; and (5) affirming the clients freedom of choice and self-direction. The role of exploring readiness to change is that this is used as a component of the therapeutic process and not an outcome. Each session followed a semi-structured interview format of MI, especially developed for this intervention programme. Participants may bring up any issues of their concern related to diabetes self-care during the intervention sessions. The participants in the intervention group may be referred by the healthcare professional to individual counselling in lifestyle modification As deemed necessary by the personnel, and these include dietary changes, promotion of physical activity, as well as counseling on smoking and alcohol habits. Control group: Medical treatment is not part of the intervention. All participants, irrespective of participation in the intervention group or the control group, will undergo the same routine check-up at GOPD in charge of their diabetes care. Biochemical tests and examinations will be performed during the visits in accordance with protocols. Individual counselling and recommendations based on the results of the examinations, biochemical tests and their self-monitoring of blood glucose will be given. Renewal of prescribed medication will be done at these check-up visits. Patients could be referred for individual counselling including diet modification, optimization of physical activity, smoking cessation if applicable, and minimization of alcohol use if required by their usual healthcare provider. 

纳入标准：

Patients will be eligible if they were diagnosed as having type 2 DM for at least one year; aged 18-65 years with poor DM control (defined asHbA1C>= 8). Those with or without maximal dosages of oral hypoglycemic agents are equally eligible.

Inclusion criteria

Patients will be eligible if they were diagnosed as having type 2 DM for at least one year; aged 18-65 years with poor DM control (defined asHbA1C>= 8). Those with or without maximal dosages of oral hypoglycemic agents are equally eligible.

排除标准：

Pregnancy, severe debilitating disease that precludes adherence to recommendations (e.g., end stage cancer), cognitive deficit and medical conditions rendering the individuals incapable to complete informed consent or participate in the study.

Exclusion criteria：

Pregnancy, severe debilitating disease that precludes adherence to recommendations (e.g., end stage cancer), cognitive deficit and medical conditions rendering the individuals incapable to complete informed consent or participate in the study.

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 2018-09-17 00:00:00 至 To 1990-01-01 00:00:00  

干预措施：

Interventions：

组别：

Two groups

样本量：

50

Group：

Two groups

Sample size：

干预措施：

Motivational interviewing, based on MI spirits, avoid righting reflex and advice, lasting approximately 30-45 min each session, for 1 year, at most every 16 weeks, up to five individual counselling sessions in 1 yr versus usual care, individual counselling with brief advice, lasting approximately 30-45 min eac

干预措施代码：

Intervention：

Motivational interviewing, based on MI spirits, avoid righting reflex and advice, lasting approximately 30-45 min each session, for 1 year, at most every 16 weeks, up to five individual counselling sessions in 1 yr versus usual care, individual counselling with brief advice, lasting approximately 30-45 min eac

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)：

Family Medicine and Primary Health Care 

单位级别：

Family Medicine and Primary Health Care 

Institution
hospital：

Family Medicine and Primary Health Care

Level of the institution：

Family Medicine and Primary Health Care

测量指标：

Outcomes：

指标中文名：

HbA1c

指标类型：

主要指标

Outcome：

HbA1c

Type：

Primary indicator

测量时间点：

baseline, 6 months, 12 months

测量方法：

blood test

Measure time point of outcome：

baseline, 6 months, 12 months

Measure method：

blood test

指标中文名：

systolic and diastolic blood pressure (BP), weight, body mass index (BMI), waist and hip circumference, fasting blood samples (fasting plasma glucose, total cholesterol, triglyceride, high-density lipoprotein (HDL) and low-density lipoprotein (LDL)), secondary psychosocial and self-care behaviou

指标类型：

次要指标

Outcome：

systolic and diastolic blood pressure (BP), weight, body mass index (BMI), waist and hip circumference, fasting blood samples (fasting plasma glucose, total cholesterol, triglyceride, high-density lipoprotein (HDL) and low-density lipoprotein (LDL)), secondary psychosocial and self-care behaviou

Type：

Secondary indicator

测量时间点：

baseline, 6 months, 12 months

测量方法：

blood test, questionaires

Measure time point of outcome：

baseline, 6 months, 12 months

Measure method：

blood test, questionaires

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 18 岁 years
最大 Max age 65 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）：

Randomized

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

Randomized

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：

Single-blind

Blinding：

Single-blind

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

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）：

Not stated

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

Not stated

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：

Not stated

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

Not stated

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2018-07-29 10:09:19