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创新性地应用mHealth提高HIV/AIDS人群心理健康的随机对照试验
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注册号:

Registration number:

ChiCTR-IPR-17012606 

最近更新日期:

Date of Last Refreshed on:

2019-08-06 

注册时间:

Date of Registration:

2017-09-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

创新性地应用mHealth提高HIV/AIDS人群心理健康的随机对照试验 

Public title:

A randomized Controlled Trial of an innovative and integrated patient-centered mHealth intervention to improve mental health of people living with HIV/AIDS 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

创新性地应用mHealth提高HIV/AIDS人群心理健康的随机对照试验 

Scientific title:

A randomized Controlled Trial of an innovative and integrated patient-centered mHealth intervention to improve mental health of people living with HIV/AIDS 

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:

郭艳 

研究负责人:

郭艳 

Applicant:

Guo Yan 

Study leader:

Guo Yan 

申请注册联系人电话:

Applicant telephone:

+86 020-87334202 

研究负责人电话:

Study leader's telephone:

+86 020-87334202 

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:

runningy@hotmail.com 

研究负责人电子邮件:

Study leader's E-mail:

runningy@hotmail.com 

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:

广东省广州市越秀区中山二路74号 

研究负责人通讯地址:

广东省广州市越秀区中山二路74号 

Applicant address:

74 Second Zhongshan Road, Guangzhou, Guangdong, China 

Study leader's address:

74 Second Zhongshan Road, Guangzhou, China 

申请注册联系人邮政编码:

Applicant postcode:

510080 

研究负责人邮政编码:

Study leader's postcode:

510080 

申请人所在单位:

中山大学公共卫生学院医学统计与流行病学系 

Applicant's institution:

Faculty of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University  

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:

L2017-051 

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件View

批准本研究的伦理委员会名称:

中山大学公共卫生学院医学研究伦理审查委员会 

Name of the ethic committee:

Institutional Review Board of School of Public Health, Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2017-08-30 

伦理委员会联系人:

凌文华 

Contact Name of the ethic committee:

Ling Wenhua 

伦理委员会联系地址:

广东省广州市越秀区中山二路74号 

Contact Address of the ethic committee:

74 Second Zhongshan Road, Guangzhou, Guangdong, China 

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:

中山大学公共卫生学院医学统计与流行病学系  

Primary sponsor:

Faculty of Medical Statistics and Epidemiology, School of Public Health, Sun Yat-sen University 

研究实施负责(组长)单位地址:

广东省广州市越秀区中山二路74号 

Primary sponsor's address:

74 Second Zhongshan Road, Guangzhou, China  

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

广东

市(区县):

Country:

China

Province:

Guangdong

City:

单位(医院):

中山大学

具体地址:

广东省广州市越秀区中山二路74号

Institution
hospital:

Sun Yat-sen University

Address:

74 Second Zhongshan Road, Guangzhou, China

经费或物资来源:

美国中华医学基金会;中国国家自然科学基金 

Source(s) of funding:

China Medical Board,General Project of National Natural Science Foundation of China 

研究疾病:

艾滋病 

Target disease:

HIV/AIDS 

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:

探索性研究/预试验 

Study phase:

研究目的:

探索和验证mHealth系统(微信公众号)对提高HIV感染者心理健康的可行性和有效性。 

Objectives of Study:

To test the feasibility and efficacy of an mHealth intervention (WeChat-based) to improve mental health of people living with HIV (PLWH).  

药物成份或治疗方案详述:

干预组患者参加Run4Love项目,内容包括由增强功能的微信平台为其推送改编的认知行为压力管理课程,并督促其进行体育锻炼。平台自动记录及监督患者的完成情况,并及时给予反馈及奖励。 

Description for medicine or protocol of treatment in detail:

Participants in the intervention group received Run4Love, adapted from cognitive-behavioral stress management (CBSM) course delivered through the enhanced WeChat platform (for 12 weeks) and were motivated to engage in physical activities. Progress of the participants was automatically tracked and monitored with timely feedback and rewards. 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1)18岁及以上; 2)HIV 检测阳性; 3)抑郁评分( CES-D) ≥16 分(可能有抑郁症状); 4)愿意提供头发样本 5)愿意并且能够使用手机应用程序及微信平台。 

Inclusion criteria

1) aged 18 years or older; 2) HIV seropositive; 3) Probably with depressive symptoms and the CES-D >=16 scores; 4) willing to provide hair samples; 5) using WeChat.  

排除标准:

1)正在服用抗精神病类药物; 2) 三个月内曾烫染过头发; 3)由于心理疾病或其他原因,不能独立完成调查或问卷填写; 4)无法阅读或收听微信发送的心理课程(如短文章、音频、海报) 5)由于身体或其他原因,无法进行体育锻炼。  

Exclusion criteria:

1) be using psychiatric drugs; 2) had hair permed or dyed in the past 3 months; 3) unable to finish the questionnaire due to mental or other illnesses or other reasons; 4) unable to read or listen to the materials sent via WeChat (i.e., short articles, audios, posters); 5) unable to engage in physical activities due to medical reasons. 

研究实施时间:

Study execute time:

From2017-09-10To 2018-10-01 

征募观察对象时间:

Recruiting time:

From2017-09-09To 2017-12-31 

干预措施:

Interventions:

组别:

干预组

样本量:

150

Group:

Experimental group

Sample size:

干预措施:

基于微信的认知行为压力管理课程,激励体育锻炼的信息,患者完成情况自动监督、及时反馈及奖励。

干预措施代码:

Intervention:

The adapted cognitive-behavioral stress management (CBSM) course delivered via WeChat, motivational messages and to encourage physical exercise, progress tracking and timely feedback and rewards on WeChat.

Intervention code:

组别:

对照组

样本量:

150

Group:

Control group

Sample size:

干预措施:

常规照护及营养手册

干预措施代码:

Intervention:

Standard care and a brochure on nutrition.

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

广东省 

市(区县):

广州市 

Country:

China 

Province:

Guangdong 

City:

Guangzhou 

单位(医院):

广州市第八人民医院 

单位级别:

三甲医院 

Institution
hospital:

Guangzhou 8th People's Hospital  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

简易应对问卷

指标类型:

次要指标 

Outcome:

Simplified Ways of Coping Questionnaire,SWCQ

Type:

Secondary indicator 

测量时间点:

基线、3个月、6个月、9个月

测量方法:

问卷调查

Measure time point of outcome:

baseline, 3-, 6-, 9-month follow-ups

Measure method:

by questionnaire using tablet

指标中文名:

患者健康问卷

指标类型:

次要指标 

Outcome:

Patient Health Questionnaire, PHQ-9

Type:

Secondary indicator 

测量时间点:

基线、1个月、2个月、3个月、6个月、9个月

测量方法:

问卷测量

Measure time point of outcome:

baseline, 1-, 2-, 3-, 6-, 9-month follow-ups

Measure method:

by questionnaire using tablet

指标中文名:

感知压力量表

指标类型:

次要指标 

Outcome:

Perceived Stress Scale

Type:

Secondary indicator 

测量时间点:

基线、3个月、6个月、9个月

测量方法:

问卷调查

Measure time point of outcome:

baseline, 3-, 6-, 9-month follow-ups

Measure method:

by questionnaire using tablet

指标中文名:

艾滋病耻辱感量表

指标类型:

次要指标 

Outcome:

HIV Stigma Scale

Type:

Secondary indicator 

测量时间点:

基线、3个月、6个月、9个月

测量方法:

问卷调查

Measure time point of outcome:

baseline, 3-, 6-, 9-month follow-ups

Measure method:

by questionnaire using tablet

指标中文名:

全球体育锻炼量表

指标类型:

次要指标 

Outcome:

Global Physical Activity Questionnaire, GPAQ

Type:

Secondary indicator 

测量时间点:

基线、3个月、6个月、9个月

测量方法:

问卷调查

Measure time point of outcome:

baseline, 3-, 6-, 9-month follow-ups

Measure method:

by questionnaire using tablet

指标中文名:

皮质醇

指标类型:

次要指标 

Outcome:

Cortisol

Type:

Secondary indicator 

测量时间点:

基线、3个月

测量方法:

头发样本检测

Measure time point of outcome:

baseline, 3-month follow-up

Measure method:

hair cortisol testing

指标中文名:

患者满意度

指标类型:

次要指标 

Outcome:

Patient satisfaction

Type:

Secondary indicator 

测量时间点:

3个月

测量方法:

问卷调查

Measure time point of outcome:

3-month follow-up

Measure method:

by questionnaire using tablet

指标中文名:

流行病调查中心用抑郁量表

指标类型:

主要指标 

Outcome:

Center for Epidemiological Studies Depression Scale, CES-D

Type:

Primary indicator 

测量时间点:

基线、3个月、6个月、9个月

测量方法:

问卷调查

Measure time point of outcome:

baseline, 3-, 6-, 9-month follow-ups

Measure method:

by questionnaire using tablet

指标中文名:

WHO 编制的 HIV/AIDS 患者生存质量简明量表

指标类型:

次要指标 

Outcome:

World Health Organization Quality of Life-HIV Brief, WHOQOL-HIV

Type:

Secondary indicator 

测量时间点:

基线、3个月、6个月、9个月

测量方法:

问卷调查

Measure time point of outcome:

baseline, 3-, 6-, 9-month follow-ups

Measure method:

by questionnaire using tablet

指标中文名:

自我效能感量表

指标类型:

次要指标 

Outcome:

General Self-Efficacy Scale, GSES

Type:

Secondary indicator 

测量时间点:

基线、3个月、6个月、9个月

测量方法:

问卷调查

Measure time point of outcome:

baseline, 3-, 6-, 9-month follow-ups

Measure method:

by questionnaire using tablet

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

头发

组织:

Sample Name:

Hair

Tissue:

人体标本去向

使用后销毁 

说明

由于头发样本没有收集到足够的量,因此未能成功获得皮质醇数据。

Fate of sample:

Destruction after use 

Note:

Hair samples were not collected properly resulting in insufficient weight for machine reading, therefore cortisol data were not available.

征募研究对象情况:

Recruiting status:

结束

Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 51 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):

为保证试验组与对照组平衡,采用区组随机化的方法,在 SAS9.4 软件中编写代码,根据随机种子生成随机数,进行随机化。区组随机化法将随机加以约束,使各处理组的分配更加均衡,满足研究需求。本研究拟纳入300名研究对象(试验组和对照组各150 名) ,根据区组随机化的要求,共分为75个区组,每个区组内有4名研究对象,再随机分配到试验组和对照组。 在招募研究对象时,根据研究对象入组的先后顺序,每位研究对象得到由上述随机方案产生的相应随机数字,根据随机数字对应的组别, 将研究对象随机分配到试验组和对照组。 本研究随机分组由统计学专业研究生独立完成,该研究生不参与本课题研究的各个过程。

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

A computer generated randomization list will be generated using complete randomization by team member.Allocation to treatment group was carried out by a computer-generated randomization list with block size of 4 using SAS software version 9.4 (SAS Institute, Inc.,Cary, NC, USA).

盲法:

不设盲

Blinding:

No blinding.

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):

如有要求时公开

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

Available upon request.

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:

电子形式的加密CRF数据保存于中山大学。

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

Encrypted CRF data in electronic format were saved in a secured server in SYSU.

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2017-09-07
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