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基於安卓作業系統的m健康幹預對早期精神疾患患者藥物治療依從性的隨機單盲對照試驗
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注册号：

Registration number：

 ChiCTR1800017286 

最近更新日期：

Date of Last Refreshed on：

 2018-07-22 18:52:57 

注册时间：

Date of Registration：

 2018-07-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基於安卓作業系統的m健康幹預對早期精神疾患患者藥物治療依從性的隨機單盲對照試驗

Public title：

An Android Operating System Based mHealth Intervention on Medication Adherence in Patient with Early Psychosis: a Single-Centre Single blinded Randomised Controlled Trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基於安卓作業系統的m健康幹預對早期精神疾患患者藥物治療依從性的隨機單盲對照試驗

Scientific title：

An Android Operating System Based mHealth Intervention on Medication Adherence in Patient with Early Psychosis: a Single-Centre Single blinded Randomised Controlled Trial

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：

Wong Hei Tung 

研究负责人：

Wong Hei Tung 

Applicant：

Wong Hei Tung 

Study leader：

Wong Hei Tung 

申请注册联系人电话：

Applicant telephone：

 +852 61572417

研究负责人电话：

Study leader's
telephone：

+852 61572417

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：

 alstonhk@yahoo.com.hk

研究负责人电子邮件：

Study leader's E-mail：

 alstonhk@yahoo.com.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：

中國香港特別行政區新界葵涌醫院道3-15號

研究负责人通讯地址：

中國香港特別行政區新界葵涌醫院道3-15號

Applicant address：

3-15 Kwai Chung Hospital Road, New Territories, Hong Kong Hong Kong Special Administrative Region, China

Study leader's address：

3-15 Kwai Chung Hospital Road, New Territories, Hong Kong Hong Kong Special Administrative Region, China

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：

葵涌醫院

Applicant's institution：

Kwai Chung Hospital

研究负责人所在单位：

葵涌醫院

Affiliation of the Leader：

Kwai Chung Hospital

是否获伦理委员会批准：

否

Approved by ethic committee：

No

伦理委员会批件文号：

Approved No. of ethic committee：

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：

Name of the ethic committee：

伦理委员会批准日期：

Date of approved by ethic committee：

 2013-08-26 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：

葵涌醫院

Primary sponsor：

Kwai Chung Hospital

研究实施负责（组长）单位地址：

中國香港特別行政區新界葵涌醫院道3-15號

Primary sponsor's address：

3-15 Kwai Chung Hospital Road, New Territories, Hong Kong Hong Kong Special Administrative Region, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Not sponsored

Source(s) of funding：

Not sponsored

研究疾病：

精神分裂症、分裂型、妄想症或ICD-10診斷的F20-F29病症  

Target disease：

Schizophrenia, schizotypal, delusional disorders or any other diagnosis coded under F20 to F29 in ICD-10

研究疾病代码：

F20 to F29

Target disease code：

F20 to F29

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

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

The primary objective of this study is to investigate the changes in medication adherence in patients suffering from early psychosis after receiving a mHealth intervention from an intervention program based on the Android operating system with features including medication reminders, follow-up reminders, side effect logs and psycho-educational materials. The secondary objective is to examine the changes in functioning, symptom control and service utilisation in patients suffering from early psychosis after receiving the above intervention.  

Objectives of Study：

The primary objective of this study is to investigate the changes in medication adherence in patients suffering from early psychosis after receiving a mHealth intervention from an intervention program based on the Android operating system with features including medication reminders, follow-up reminders, side effect logs and psycho-educational materials. The secondary objective is to examine the changes in functioning, symptom control and service utilisation in patients suffering from early psychosis after receiving the above intervention.

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：

1. Any current diagnosis of other mental and behavioural disorder diagnosed according to the criteria of ICD-10 apart from those coded under F20 to F29;
2. On depot or as needed basis treatment regime only without regular oral medication;
3. Organic brain condition;
4. Substance abuse in the last 12 months;
5. Intellectual developmental disorder;
6. Inability to provide written informed consent;
7. Mentally unstable, as defined by Clinical Global Impression – Severity scale score greater or equal to four.

Exclusion criteria：

1. Any current diagnosis of other mental and behavioural disorder diagnosed according to the criteria of ICD-10 apart from those coded under F20 to F29;
2. On depot or as needed basis treatment regime only without regular oral medication;
3. Organic brain condition;
4. Substance abuse in the last 12 months;
5. Intellectual developmental disorder;
6. Inability to provide written informed consent;
7. Mentally unstable, as defined by Clinical Global Impression – Severity scale score greater or equal to four.

研究实施时间：

Study execute time：

从 From 2018-08-01 00:00:00至 To 2019-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2018-08-01 00:00:00 至 To 2019-04-30 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 50

Group：

1

Sample size：

干预措施：

基於安卓作業系統的m健康干預

干预措施代码：

Intervention：

An Android Operating System Based mHealth Intervention

Intervention code：

组别：

2

样本量：

 50

Group：

2

Sample size：

干预措施：

安慰模擬作業系統

干预措施代码：

Intervention：

Placebo Program

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中國

省(直辖市)：

 香港特別行政區 

市(区县)：

  

Country：

China

Province：

Hong Kong SAR

City：

Hong Kong

单位(医院)：

 葵涌醫院 

单位级别：

 醫院管理局葵涌醫院 

Institution
hospital：

Kwai Chung Hospital

Level of the institution：

Hospital Authority

测量指标：

Outcomes：

指标中文名：

participants’ own estimation of percentage of pills they have taken

指标类型：

主要指标

Outcome：

participants’ own estimation of percentage of pills they have taken

Type：

Primary indicator

测量时间点：

12 weeks

测量方法：

interview

Measure time point of outcome：

12 weeks

Measure method：

interview

指标中文名：

Medication Adherence Rating Scale

指标类型：

主要指标

Outcome：

Medication Adherence Rating Scale

Type：

Primary indicator

测量时间点：

12 weeks

测量方法：

Questionnaire

Measure time point of outcome：

12 weeks

Measure method：

Questionnaire

指标中文名：

Drug Attitude Inventory

指标类型：

主要指标

Outcome：

Drug Attitude Inventory

Type：

Primary indicator

测量时间点：

12 weeks

测量方法：

Questionnaire

Measure time point of outcome：

12 weeks

Measure method：

Questionnaire

指标中文名：

pill count

指标类型：

主要指标

Outcome：

pill count

Type：

Primary indicator

测量时间点：

12 weeks

测量方法：

by outreach visiting by nurse

Measure time point of outcome：

12 weeks

Measure method：

by outreach visiting by nurse

指标中文名：

Social and Occupational Functioning Assessment Scale

指标类型：

次要指标

Outcome：

Social and Occupational Functioning Assessment Scale

Type：

Secondary indicator

测量时间点：

12 weeks

测量方法：

interview

Measure time point of outcome：

12 weeks

Measure method：

interview

指标中文名：

Positive and Negative Syndrome Scale

指标类型：

次要指标

Outcome：

Positive and Negative Syndrome Scale

Type：

Secondary indicator

测量时间点：

12 weeks

测量方法：

interview

Measure time point of outcome：

12 weeks

Measure method：

interview

指标中文名：

Degree of service utilisation

指标类型：

次要指标

Outcome：

Degree of service utilisation

Type：

Secondary indicator

测量时间点：

12 weeks

测量方法：

hospital record tracing

Measure time point of outcome：

12 weeks

Measure method：

hospital record tracing

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 岁 years
最大 Max age 64 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）：

Generated by nurse via computer generated random number

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

Generated by nurse via computer generated random number

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：

This is considered a single-blinded (rater-blinded) study as the intervention program will allocate the participants into intervention or control group only after the random number is generated, which would be sealed until the end of intervention data collection. The principal investigator would therefore be blinded from the allocation of treatment during data collection. Participants and care providers are not considered as blinded due to the significant difference in the program features for the intervention and control groups. A placebo page has been designed for the control group to minimise the placebo effect. Statistical analysis would be performed by the principal investigator after acknowledging the treatment allocation result and is therefore not blinded. The principal investigator will make an impression if participants are allocated into intervention or control group before data collection and the participant will be asked to guess if they are in the intervention group or control group after outcome data collection to estimate if the blinding procedure is successful.

Blinding：

This is considered a single-blinded (rater-blinded) study as the intervention program will allocate the participants into intervention or control group only after the random number is generated, which would be sealed until the end of intervention data collection. The principal investigator would therefore be blinded from the allocation of treatment during data collection. Participants and care providers are not considered as blinded due to the significant difference in the program features for the intervention and control groups. A placebo page has been designed for the control group to minimise the placebo effect. Statistical analysis would be performed by the principal investigator after acknowledging the treatment allocation result and is therefore not blinded. The principal investigator will make an impression if participants are allocated into intervention or control group before data collection and the participant will be asked to guess if they are in the intervention group or control group after outcome data collection to estimate if the blinding procedure is successful.

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

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）：

Completed trial result will be submitted to the Hong Kong College of Psychiatrists (http://www.hkcpsych.org.hk/index.php?lang=cn)

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

Completed trial result will be submitted to the Hong Kong College of Psychiatrists (http://www.hkcpsych.org.hk/index.php?lang=cn)

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：

Data collected and managed by the study leader entirely using data collecting sheet. All information collected would be kept confidential, accessed and handled by the principal investigator only. Hard copies would be kept in a locked cabinet and electronic records will be encrypted with passwords. Data collected will be kept for seven years after the completion of studies and hard copies would be shredded and electronic records permanently deleted. Overall, the data handling will follow hospital patient privacy guidelines. No personal identifiers, including name, Hong Kong Identification Card Number or address will be used in the study.

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

Data collected and managed by the study leader entirely using data collecting sheet. All information collected would be kept confidential, accessed and handled by the principal investigator only. Hard copies would be kept in a locked cabinet and electronic records will be encrypted with passwords. Data collected will be kept for seven years after the completion of studies and hard copies would be shredded and electronic records permanently deleted. Overall, the data handling will follow hospital patient privacy guidelines. No personal identifiers, including name, Hong Kong Identification Card Number or address will be used in the study.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2018-07-22 18:52:57
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