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: |
|
||||||||||||||||||||||
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: |
0 |
||||||||||||||||||||||
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: |
从From2017-09-10至To 2018-10-01 |
征募观察对象时间: Recruiting time: |
从From2017-09-09至To 2017-12-31 |
干预措施: Interventions: |
|
研究实施地点: Countries of recruitment and research settings: |
|
测量指标: Outcomes: |
|
采集人体标本:
Collecting sample(s)
|
|
征募研究对象情况: Recruiting status: |
结束 Completed |
年龄范围: Participant age: |
|
||||||
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 |