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Effectiveness of Use of the Health-Improvement Card by Supervised Physiotherapy Students: A Health Promotion Strategy for Community-dwelling Adults in Shanghai

注册号：

Registration number：

ITMCTR1900002564

最近更新日期：

Date of Last Refreshed on：

2019-09-02

注册时间：

Date of Registration：

2019-09-02

注册号状态：

Registration Status：

补注册

Retrospective registration

注册题目：

Effectiveness of Use of the Health-Improvement Card by Supervised Physiotherapy Students: A Health Promotion Strategy for Community-dwelling Adults in Shanghai

Public title：

Effectiveness of Use of the Health-Improvement Card by Supervised Physiotherapy Students: A Health Promotion Strategy for Community-dwelling Adults in Shanghai

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Effectiveness of Use of the Health-Improvement Card by Supervised Physiotherapy Students: A Health Promotion Strategy for Community-dwelling Adults in Shanghai

Scientific title：

Effectiveness of Use of the Health-Improvement Card by Supervised Physiotherapy Students: A Health Promotion Strategy for Community-dwelling Adults in Shanghai

研究课题的正式科学名称简写：

Scientific title acronym：

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：

ChiCTR1900025616 ; ChiMCTR1900002564

申请注册联系人：

柏怡文

研究负责人：

吴绪波

Applicant：

YIWEN BAI

Study leader：

XUBO WU

申请注册联系人电话：

Applicant telephone：

+86 18817775603

研究负责人电话：

Study leader's telephone：

+86 18616028857

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：

baiyiwen0507@163.com

研究负责人电子邮件：

Study leader's E-mail：

wuxubo320@163.com

申请单位网址(自愿提供)：

Study leader's 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：

中国上海浦东新区高桥大同路358号

研究负责人通讯地址：

中国上海浦东新区高桥大同路358号

Applicant address：

358 Datong Road, Gaoqiao, Pudong New Area, Shanghai, China

Study leader's address：

358 Datong Road, Gaoqiao, Pudong New Area, Shanghai

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：

上海中医药大学

Applicant's institution：

Shanghai University of Traditional Chinese Medicine

是否获伦理委员会批准：

Approved by ethic committee：

伦理委员会批件文号：

Approved No. of ethic committee：

2018-IRBQY-013

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：

上海中医药大学第七人民医院伦理委员会

Name of the ethic committee：

Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine Ethic Committee

伦理委员会批准日期：

Date of approved by ethic committee：

2018/9/21 0:00:00

伦理委员会联系人：

王民

Contact Name of the ethic committee：

WANG MIN

伦理委员会联系地址：

中国上海浦东新区高桥大同路358号

Contact Address of the ethic committee：

358 Datong Road, Gaoqiao, Pudong New Area, Shanghai

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：

上海中医药大学第七人民医院

Primary sponsor：

Seventh People's Hospital of Shanghai University of Traditional Chinese Medicine

研究实施负责（组长）单位地址：

中国上海浦东新区高桥大同路358号

Primary sponsor's address：

358 Datong Road, Gaoqiao, Pudong New Area, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海第七人民医院

具体地址：

浦东新区高桥大同路358号

Institution
hospital：

SHANGHAI SEVENTH HOSPITAL

Address：

358 Datong Road, Gaoqiao, Pudong New Area, Shanghai

经费或物资来源：

上海第七人民医院

Source(s) of funding：

Three-year project of accelerating develpoment of traditional Chinese medicine focused on Chinese and Western rehabilitation (ZY (2018-20 20)-FWTX-8005)

研究疾病：

non-communicable diseases

研究疾病代码：

Target disease：

non-communicable diseases

Target disease code：

研究类型：

Study type：

干预性研究

Interventional study

研究设计：

Study design：

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段：

Study phase：

I期临床试验

Phase I clinical trial

研究目的：

The aim of this study is to examine the effectiveness of physiotherapy students in effecting positive lifestyle behaviour change related to NCD risk factors using the HIC, in community-dwelling adults. Specifically, we will examine the changes in biometric data and lifestyle behaviours in a cohort of Chinese community-dwelling adults, at 3 months after the HIC was introduced to them by physiotherapy students, under the supervision of their educators.

Objectives of Study：

The aim of this study is to examine the effectiveness of physiotherapy students in effecting positive lifestyle behaviour change related to NCD risk factors using the HIC, in community-dwelling adults. Specifically, we will examine the changes in biometric data and lifestyle behaviours in a cohort of Chinese community-dwelling adults, at 3 months after the HIC was introduced to them by physiotherapy students, under the supervision of their educators.

药物成份或治疗方案详述：

Participants in the experimental group will meet with a physiotherapy student (under the supervision of a physiotherapy educator) who will, based on the information on the completed HIC, discuss the current health status of the participant. Participants with ‘identified’ moderate- or high-risk biometric scores and/or lifestyle behaviours in the moderate- to high-risk zones will receive targeted health education including goal setting to achieve the low-risk zone. As needed they will be provided the requisite health education including a prescribed individualised exercise program. Participants in the experimental group will meet with the same physiotherapy student one month after the initial discussion meeting, for follow up of adherence of the action plan and have actions modified if necessary.

Description for medicine or protocol of treatment in detail：

Participants in the experimental group will meet with a physiotherapy student (under the supervision of a physiotherapy educator) who will, based on the information on the completed HIC, discuss the current health status of the participant. Participants with identified moderate- or high-risk biometric scores and/or lifestyle behaviours in the moderate- to high-risk zones will receive targeted health education including goal setting to achieve the low-risk zone. As needed they will be provided the requisite health education including a prescribed individualised exercise program. Participants in the experimental group will meet with the same physiotherapy student one month after the initial discussion meeting, for follow up of adherence of the action plan and have actions modified if necessary.

纳入标准：

1) community-dwelling adults aged 41 to 89 years who are literate and have satisfactory reading vision; 2) without cardiac dysrhythmia, heart failure, post-infarction angina or history of cardiogenic shock; 3) voluntary participation in research, and have good communication skills.

Inclusion criteria

1) community-dwelling adults aged 41 to 89 years who are literate and have satisfactory reading vision; 2) without cardiac dysrhythmia, heart failure, post-infarction angina or history of cardiogenic shock; 3) voluntary participation in research, and have good communication skills.

排除标准：

1) non-resident of Shanghai; 2) with known mental illness, dementia or communication difficulty; 3) with severe heart, liver, or kidney dysfunction, malignant tumours.

Exclusion criteria：

1) non-resident of Shanghai; 2) with known mental illness, dementia or communication difficulty; 3) with severe heart, liver, or kidney dysfunction, malignant tumours.

研究实施时间：

Study execute time：

从From 2019-01-01

至To      2019-06-30

征募观察对象时间：

Recruiting time：

从From 2019-01-01

至To      2019-03-01

干预措施：

Interventions：

组别：

试验组

样本量：

100

Group：

Experimental group

Sample size：

干预措施：

will be provided with advice to modify lifestyle behaviour and prescribed an individualised exercise program (under the supervision of the physiotherapy educator).

干预措施代码：

Intervention：

will be provided with advice to modify lifestyle behaviour and prescribed an individualised exercise program (under the supervision of the physiotherapy educator).

Intervention code：

组别：

对照组

样本量：

100

Group：

Control group

Sample size：

干预措施：

receives a handbook on regular health education (including healthy diet, smoking cessation, regular exercise, alcohol consumption)

干预措施代码：

Intervention：

receives a handbook on regular health education (including healthy diet, smoking cessation, regular exercise, alcohol consumption)

Intervention code：

样本总量 Total sample size ： 200

研究实施地点：

Countries of recruitment
and research settings：

国家：

中国

省(直辖市)：

上海

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海第七人民医院

单位级别：

三甲医院

Institution/hospital：

SHANGHAI SEVENTH HOSPITAL

Level of the institution：

Tertiary A Hospital

测量指标：

Outcomes：

指标中文名：

睡眠质量（PROMIS Scale）

指标类型：

次要指标

Outcome：

Sleep Quality

Type：

Secondary indicator

测量时间点：

测量方法：

匹茨堡睡眠质量量表

Measure time point of outcome：

3 months

Measure method：

Pittsburgh Sleep Quality Index

指标中文名：

焦虑、抑郁评估

指标类型：

次要指标

Outcome：

anxiety and depression

Type：

Secondary indicator

测量时间点：

3个月

测量方法：

Measure time point of outcome：

3 months

Measure method：

指标中文名：

生活质量

指标类型：

主要指标

Outcome：

Quality of life

Type：

Primary indicator

测量时间点：

3个月

测量方法：

SF-36 健康调查简表

Measure time point of outcome：

3 months

Measure method：

SF-36 questionnaire

指标中文名：

腰围

指标类型：

次要指标

Outcome：

waist circumference

Type：

Secondary indicator

测量时间点：

3个月

测量方法：

Measure time point of outcome：

3 months

Measure method：

指标中文名：

体质指数

指标类型：

次要指标

Outcome：

body mass index

Type：

Secondary indicator

测量时间点：

3个月

测量方法：

Measure time point of outcome：

3 months

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Finger Blood

Tissue：

人体标本去向

使用后销毁

说明

Fate of sample 

Destruction after use

Note：

征募研究对象情况：

结束

Completed

年龄范围：

最小 50 岁
Min age years
最大 90 岁
Max age years

Recruiting status：

Participant age：

性别：

Gender：

男女均可

Both

随机方法（请说明由何人用什么方法产生随机序列）：

computer-generated sequence

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

Eligible participants were initially evaluated for basic characteristics, past medical history, and general health situation. Patients eligible for the study were randomly allocated to control group and HIC intervention group according to a computer-generated sequence using a simple randomization method. The randomization list&#32

盲法：

未说明

Blinding：

Not stated

是否共享原始数据：

IPD sharing：

是

Yes

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）：

ResMan临床试验公共管理平台

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

2019-12-01 metadata; ResMan

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：

repository，excel

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

repository，excel

数据管理委员会：

Data Managemen Committee：

暂未确定

Not yet

研究计划书或研究结果报告发表信息
（杂志名称、期、卷、页，时间；或网址）：

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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