Today is 2020-11-27

A mHealth-based randomized controlled trial for improving mental health among people living with HIV during the COVID-19 outbreak
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注册号:

Registration number:

ChiCTR2000038866 

最近更新日期:

Date of Last Refreshed on:

2020-10-07 

注册时间:

Date of Registration:

2020-10-07 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于mHealth的新型冠状病毒肺炎疫情下HIV感染者的心理健康干预研究 

Public title:

A mHealth-based randomized controlled trial for improving mental health among people living with HIV during the COVID-19 outbreak 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于mHealth的新型冠状病毒肺炎疫情下HIV感染者的心理健康干预研究 

Scientific title:

A mHealth-based randomized controlled trial for improving mental health among people living with HIV during the COVID-19 outbreak 

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:

曾愉 

研究负责人:

郭艳 

Applicant:

Yu Zeng 

Study leader:

Yan Guo 

申请注册联系人电话:

Applicant telephone:

+86 18819473072 

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:

zengy56@mail2.sysu.edu.cn 

研究负责人电子邮件:

Study leader's E-mail:

guoy8@mail.sysu.edu.cn 

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:

广州市越秀区中山二路74号中山大学公共卫生学院医学统计学系327室 

研究负责人通讯地址:

广东省广州市越秀区中山二路74号中山大学公共卫生学院医学统计学系321室 

Applicant address:

74 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

Study leader's address:

74 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, China 

申请注册联系人邮政编码:

Applicant postcode:

510000 

研究负责人邮政编码:

Study leader's postcode:

510000 

申请人所在单位:

中山大学公共卫生学院医学统计学系 

Applicant's institution:

Department of Medical Statistics, 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:

中大公卫医伦〔2020〕第090号 

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:

The institutional review board of the School of Public Health, Sun Yat-sen University 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-08-13 

伦理委员会联系人:

丁莹 

Contact Name of the ethic committee:

Ding Ying 

伦理委员会联系地址:

广州市越秀区中山二路74号中山大学北校区 

Contact Address of the ethic committee:

74 Second Zhongshan Road, Yuexiu District, 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:

dingy69@mail.sysu.edu.cn 

研究实施负责(组长)单位:

中山大学公共卫生学院医学统计学系 

Primary sponsor:

Department of Medical Statistics, School of Public Health, Sun Yat-sen University 

研究实施负责(组长)单位地址:

广州市越秀区中山二路74号中山大学公共卫生学院医学统计学系321室 

Primary sponsor's address:

74 Second Zhongshan Road, Yuexiu District, Guangzhou, Guangdong, 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):

广东省

市(区县):

广州市

Country:

China

Province:

Guangdong

City:

Guangzhou

单位(医院):

中山大学

具体地址:

越秀区中山二路74号中山大学公共卫生学院医学统计学系321室

Institution
hospital:

Sun Yat-sen University

Address:

74 Second Zhongshan Road, Yuexiu District

经费或物资来源:

自筹 

Source(s) of funding:

Self-funding 

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:

探索在新型冠状病毒肺炎疫情期间,mHealth干预对提高可能有抑郁症状的HIV感染者的抑郁症状、生存质量等健康结局的可行性和有效性。 

Objectives of Study:

To explore the feasibility and effectiveness of an mHealth intervention to improve health outcomes such as depressive symptoms and quality of life among people living with HIV and elevated depressive symtoms during the COVID-19 outbreak. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

随机平行对照 

Study design:

Parallel 

纳入标准:

1.年满18周岁; 2.HIV检测阳性; 3.抑郁评分(CES-D)≥16分(有抑郁症状); 4.新冠疫情期间在国内居住; 5.使用手机微信; 6.具备理解能力,能签署知情同意书。 

Inclusion criteria

1. Aged >=18 years; 2. HIV seropositive; 3. Having elevated depressive symptoms (measured by the Center for Epidemiologic Studies-Depression Scale [CES-D]>=16); 4. Living in China during the COVID-19 outbreak; 5. Using WeChat on mobile phone; 6. Being able to understand and sign the informed consent. 

排除标准:

1.已服用抗精神病类药物; 2.无法完成调查问卷填写; 3.无法使用手机完成干预内容。 

Exclusion criteria:

1. Currently on psychiatric treatment; 2. Unable to complete the survey; 3. Unable to use a mobile phone to read or listen to the intervention materials. 

研究实施时间:

Study execute time:

From2020-10-15To 2021-12-31 

征募观察对象时间:

Recruiting time:

From2020-10-15To 2021-03-25 

干预措施:

Interventions:

组别:

干预组

样本量:

60

Group:

Intervention Group

Sample size:

干预措施:

基于微信的认知行为压力管理课程 + 针对疫情期间HIV感染者的特殊问题的文章和音频

干预措施代码:

Intervention:

WeChat-based Cognitive-Behavior and Stress Management courses + Articles and audios on the special needs and problems of people living with HIV during the COVID-19 outbreak

Intervention code:

组别:

对照组

样本量:

60

Group:

Control Group

Sample size:

干预措施:

针对HIV感染者的健康知识手册

干预措施代码:

Intervention:

A brochure on nutrition and healthy living for people living with HIV

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 Eighth People's Hospital i  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

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、基线后每两周一次至三个月随访

测量方法:

自填

Measure time point of outcome:

Baseline and then every two weeks after baseline until 3-month follow-up (i.e. 2-, 4-, 6-, 8-, 10-, 12-week follow-ups)

Measure method:

Self-report

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、两个月、三个月

测量方法:

自填

Measure time point of outcome:

Baseline, 2-month, and 3-month follow-ups

Measure method:

Self-report

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、两个月、三个月

测量方法:

自填

Measure time point of outcome:

Baseline, 2-month, and 3-month follow-ups

Measure method:

Self-report

指标中文名:

积极应对量表

指标类型:

次要指标 

Outcome:

The subscale of postive coping in Simplified Ways of Coping Questionnaire

Type:

Secondary indicator 

测量时间点:

基线、两个月、三个月

测量方法:

自填

Measure time point of outcome:

Baseline, 2-month, and 3-month follow-ups

Measure method:

Self-report

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、两个月、三个月

测量方法:

自填

Measure time point of outcome:

Baseline, 2-month, and 3-month follow-ups

Measure method:

Self-report

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 years
最大 Max age 70 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):

统计学专家通过SAS 9.2实施区组随机化。本研究拟纳入120名研究对象,共分为30个区组,每个区组内有4名研究对象。根据入组的先后顺序,每位研究对象得到一个随机数字,根据随机数字对应的组别,被随机分配到试验组或对照组。

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

Block randomization will be conducted by a biostatistician using SAS9.2. A total of 120 participants will be divided into 30 blocks, with 4 participants in each block. Each participant will be given a random number and assigned randomly to either the intervention or control group.

盲法:

开放试验

Blinding:

Open-label trial

原始数据公开时间:

The time of sharing IPD:

Within six months after the trial complete

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):

试验结束、论文完成并发表后,可以以电子文件的形式将原始数据在中国临床试验注册中心公开

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

Data will be shared on the website of the Chinese clinical registry after the completion of the trial and results publications.

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:

原始数据通过电子问卷(问卷星)采集,通过Excel电子数据库形式储存于研究单位。

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

The original data will be collected through electronic questionnaires (Questionnaire star) and will be stored in the research institute in the form of Excel spreadsheet with an encrypted code.

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2020-10-07
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