简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
用雲端技術（IMPACT研究）去改善高血壓管理的隨機對照研究
下载XML文档

注册号：

Registration number：

 ChiCTR-TRC-14004903 

最近更新日期：

Date of Last Refreshed on：

 2014-10-16 19:51:41 

注册时间：

Date of Registration：

 2014-06-27 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

用雲端技術（IMPACT研究）去改善高血壓管理的隨機對照研究

Public title：

Improving Management and Patient Empowerment using Cloud Technology Among Hypertensive (IMPACT study): A randomised controlled trial

注册题目简写：

English Acronym：

IMPACT

研究课题的正式科学名称：

用雲端技術（IMPACT研究）去改善高血壓管理的隨機對照研究

Scientific title：

Improving Management and Patient Empowerment using Cloud Technology Among Hypertensive

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：

KAREN YIU 

研究负责人：

PROF. BENJAMIN YIP 

Applicant：

KAREN YIU 

Study leader：

PROF. BENJAMIN YIP 

申请注册联系人电话：

Applicant telephone：

 +852 26095117

研究负责人电话：

Study leader's
telephone：

+852 2252 8799

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：

 karenyiu@cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 benyip@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：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

研究负责人通讯地址：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

Applicant address：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

Study leader's address：

4/F, School of Public Health, Prince of Wales Hospital, Shatin, N.T., HK

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：

SCHOOL OF PUBLIC HEALTH AND PRIMARY CARE

Applicant's institution：

SCHOOL OF PUBLIC HEALTH AND PRIMARY CARE

研究负责人所在单位：

Affiliation of the Leader：

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：

 CRE.2013.662

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：

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

Name of the ethic committee：

The 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：

 2014-05-29 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：

PCCW

Primary sponsor：

PCCW

研究实施负责（组长）单位地址：

PCCW TOWER, TAIKOO PLACE, 979 KING'S ROAD, QUARRY BAY, HK

Primary sponsor's address：

PCCW TOWER, TAIKOO PLACE, 979 KING'S ROAD, QUARRY BAY, HK

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

China

省(直辖市)：

Hong Kong

市(区县)：

Country：

China

Province：

Hong Kong

City：

单位(医院)：

LEK YUEN HEALTH CENTER

具体地址：

LEK YUEN HEALTH CENTER

Institution
hospital：

LEK YUEN HEALTH CENTER

Address：

LEK YUEN HEALTH CENTER

经费或物资来源：

Health and Medical Research Fund (HMRF)

Source(s) of funding：

Health and Medical Research Fund (HMRF)

研究疾病：

HYPERTENSION  

Target disease：

HYPERTENSION

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：

 IV期临床试验 

Study phase：

4

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The primary aim of the study is to assess the effect of intervention relative to usual care on increasing the proportion of patients with controlled BP (defined as less than 140 mm Hg systolic and less than 90 mm Hg diastolic; less than 130 mm Hg systolic and less than 80 mm Hg diastolic in patients with diabetes or kidney disease) among hypertensive patients with suboptimal BP control at the 12 month follow-up clinic visit. 2.After 12 months, nurses will no longer monitor patients. However, patients will be followed up at 18 months to investigate the durability of the intervention effects, in terms of the proportion of patients with controlled clinic-based BP measurements; 3.The impact of the intervention on patient satisfaction and empowerment will also be assessed.  

Objectives of Study：

The primary aim of the study is to assess the effect of intervention relative to usual care on increasing the proportion of patients with controlled BP (defined as less than 140 mm Hg systolic and less than 90 mm Hg diastolic; less than 130 mm Hg systolic and less than 80 mm Hg diastolic in patients with diabetes or kidney disease) among hypertensive patients with suboptimal BP control at the 12 month follow-up clinic visit. 2.After 12 months, nurses will no longer monitor patients. However, patients will be followed up at 18 months to investigate the durability of the intervention effects, in terms of the proportion of patients with controlled clinic-based BP measurements; 3.The impact of the intervention on patient satisfaction and empowerment will also be assessed.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

Medical exclusion criteria include the following: the occurrence of known stage 4 or stage 5 kidney disease, acute coronary syndrome, coronary revascularization procedure or stroke within the past three months; known secondary causes of hypertension like coarctation of the aorta, pheochromocytoma, adrenocortical hypertension or renovascular hypertension; class III (marked limitation of physical activity) or IV (symptoms at rest) New York Heart Association classification; or known left ventricular ejection fraction less than 30%. Other additional exclusion criteria: unwillingness to be followed for a period of 18 months; pregnancy or intention to become pregnant in the next two years for females; participation in another clinical trial; spouse having already participated in this study; difficulty with communication in Cantonese; dementia, mental illness or any condition that would limit ability to give informed consent; or upper arm circumference longer than 18 inches (indicating BP cuff on telemonitoring device may not be accurate without modification).

Exclusion criteria：

Medical exclusion criteria include the following: the occurrence of known stage 4 or stage 5 kidney disease, acute coronary syndrome, coronary revascularization procedure or stroke within the past three months; known secondary causes of hypertension like coarctation of the aorta, pheochromocytoma, adrenocortical hypertension or renovascular hypertension; class III (marked limitation of physical activity) or IV (symptoms at rest) New York Heart Association classification; or known left ventricular ejection fraction less than 30%. Other additional exclusion criteria: unwillingness to be followed for a period of 18 months; pregnancy or intention to become pregnant in the next two years for females; participation in another clinical trial; spouse having already participated in this study; difficulty with communication in Cantonese; dementia, mental illness or any condition that would limit ability to give informed consent; or upper arm circumference longer than 18 inches (indicating BP cuff on telemonitoring device may not be accurate without modification).

研究实施时间：

Study execute time：

从 From 2014-07-14 00:00:00至 To 2016-05-14 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2014-07-14 00:00:00 至 To 2014-12-31 00:00:00

干预措施：

Interventions：

组别：

BLOOD PRESSURE MACHINE

样本量：

 300

Group：

BLOOD PRESSURE MACHINE

Sample size：

干预措施：

taking medication FREE BLOOD PRESSURE PROVIDED

干预措施代码：

Intervention：

taking medication FREE BLOOD PRESSURE PROVIDED

Intervention code：

组别：

Control

样本量：

 300

Group：

Control

Sample size：

干预措施：

not taking medication

干预措施代码：

Intervention：

taking no medication

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 China

省(直辖市)：

 Hong Kong 

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

 LEK YUEN HEALTH CENTE 

单位级别：

 LEK YUEN HEALTH CENTE 

Institution
hospital：

LEK YUEN HEALTH CENTE

Level of the institution：

LEK YUEN HEALTH CENTE

测量指标：

Outcomes：

指标中文名：

Participating patients can improve their self mana

指标类型：

主要指标

Outcome：

Participating patients can improve their self mana

Type：

Primary 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 21 岁 years
最大 Max age 100 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 stratified randomization for antihypertensive medication use (i.e., taking medication or not taking

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

Block stratified randomization for antihypertensive medication use (i.e., taking medication or not taking)

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：

Block stratified randomization for antihypertensive medication use (i.e., taking medication or not taking medication) will be used to ensure a balanced frequency of antihypertensive medication in each group. An independent statistician will generate a pre-determined random number table using Microsoft Excel. Research staff will use the randomization number generated to assign patients to one of the two arms of the trial. Nurse or HA clerk who measure the clinic-based BP will be blinded to the study design and intervention assignment. The allocation will be concealed from the health care assistants and professionals who carry out the annual assessment.

Blinding：

Block stratified randomization for antihypertensive medication use (i.e., taking medication or not taking medication) will be used to ensure a balanced frequency of antihypertensive medication in each group. An independent statistician will generate a pre-determined random number table using Microsoft Excel. Research staff will use the randomization number generated to assign patients to one of the two arms of the trial. Nurse or HA clerk who measure the clinic-based BP will be blinded to the study design and intervention assignment. The allocation will be concealed from the health care assistants and professionals who carry out the annual assessment.

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

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）：

SCHOOL OF PUBLIC HEALTH AND PRIMARY CARE, THE CHINESE UNIVERSITY OF HONG KONG

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

SCHOOL OF PUBLIC HEALTH AND PRIMARY CARE, THE CHINESE UNIVERSITY OF HONG KONG

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：

SCHOOL OF PUBLIC HEALTH AND PRIMARY CARE, THE CHINESE UNIVERSITY OF HONG KONG

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

SCHOOL OF PUBLIC HEALTH AND PRIMARY CARE, THE CHINESE UNIVERSITY OF HONG KONG

数据与安全监察委员会：

Data and Safety Monitoring Committee：

注册人：

Name of Registration：

  2014-07-07 00:00:00
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统