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The effectiveness of MICM to improve medication adherence for dual-diagnosed patients
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注册号：

Registration number：

 ChiCTR2100050197 

最近更新日期：

Date of Last Refreshed on：

 2021-08-22 06:17:23 

注册时间：

Date of Registration：

 2021-08-22 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

The effectiveness of MICM to improve medication adherence for dual-diagnosed patients

Public title：

The effectiveness of MICM to improve medication adherence for dual-diagnosed patients

注册题目简写：

English Acronym：

研究课题的正式科学名称：

A pilot randomized controlled trial of integrative Motivational Interviewing and Contingency Management program (MICM) for dual-diagnosed patients to enhance psychiatric medication adherence

Scientific title：

A pilot randomized controlled trial of integrative Motivational Interviewing and Contingency Management program (MICM) for dual-diagnosed patients to enhance psychiatric medication adherence

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：

IP CHI KIN 

研究负责人：

IP CHI KIN 

Applicant：

IP CHI KIN 

Study leader：

IP CHI KIN 

申请注册联系人电话：

Applicant telephone：

 +852 91398360

研究负责人电话：

Study leader's
telephone：

+852 91398360

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：

 1004373190@link.cuhk.edu.hk

研究负责人电子邮件：

Study leader's E-mail：

 1004373190@link.cuhk.edu.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：

香港新界北區上水保健路9號

研究负责人通讯地址：

香港新界北區上水保健路9號

Applicant address：

9 Health Care Road, Sheung Shui, North New Territories, Hong Kong, China

Study leader's address：

9 Health Care Road, Sheung Shui, North New Territories, Hong Kong, 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：

香港北區醫院

Applicant's institution：

NORTH DISTRICT HOSPITAL

研究负责人所在单位：

香港北區醫院

Affiliation of the Leader：

NORTH DISTRICT HOSPITAL

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：

 2021.028

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：

香港中文大學-新界東醫院聯網臨床研究倫理聯席委員會

Name of the ethic committee：

JOINT CHINESE UNIVERSITY OF HONG KONG-NEW TERRITORIES EAST CLUSTER CLINICAL RESEARCH ETHICS COMMITTEE

伦理委员会批准日期：

Date of approved by ethic committee：

 2021-08-04 00:00:00

伦理委员会联系人：

Envy Lee

Contact Name of the ethic committee：

Envy Lee

伦理委员会联系地址：

中國香港特別行政區新界沙田銀城街威爾士親王醫院呂志和臨床醫學大樓8樓

Contact Address of the ethic committee：

8/F, Lui Che Woo Clinical Sciences Building, Prince of Wales Hospital, Shatin, Hong Kong, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 35053935

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：

N/A

Primary sponsor：

NIL

研究实施负责（组长）单位地址：

Nil

Primary sponsor's address：

NIL

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

SELF

Source(s) of funding：

SELF

研究疾病：

SUBSTANCE USE DISORDER WITH ANY TYPE OF PSYCHIATRIC DISORDERS  

Target disease：

SUBSTANCE USE DISORDER WITH ANY TYPE OF PSYCHIATRIC DISORDERS

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：

 I期临床试验 

Study phase：

1

研究设计：

随机抽样 

Study design：

Randomly Sampling 

研究目的：

The proposed project will adopt a single-blinded, multi-centre pilot randomized controlled trial (RCT) design to determine the feasibility and preliminary effectiveness of a multi-model, integrative Motivational Interviewing and Contingency Management program (MICM), in comparison with the usual care (i.e., case management), at immediately after intervention and 3-months post-intervention. The following outcomes will be assessed: 1. medication adherence (primary outcome); and 2. psychiatric symptoms, frequency of substance abuse and psychiatric hospitalizations (secondary outcomes). Moreover, the perceived usefulness and areas of improvement of the MICM program will be evaluated to make necessary improvement in the future clinical application.  

Objectives of Study：

The proposed project will adopt a single-blinded, multi-centre pilot randomized controlled trial (RCT) design to determine the feasibility and preliminary effectiveness of a multi-model, integrative Motivational Interviewing and Contingency Management program (MICM), in comparison with the usual care (i.e., case management), at immediately after intervention and 3-months post-intervention. The following outcomes will be assessed: 1. medication adherence (primary outcome); and 2. psychiatric symptoms, frequency of substance abuse and psychiatric hospitalizations (secondary outcomes). Moreover, the perceived usefulness and areas of improvement of the MICM program will be evaluated to make necessary improvement in the future clinical application.

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. Having organic psychiatric disorder AND/OR learning disability;
2. Having been prescribed depot-only (injection) medication or no medication;
3. Having visual, language or communication difficulties.

Exclusion criteria：

1. Having organic psychiatric disorder AND/OR learning disability;
2. Having been prescribed depot-only (injection) medication or no medication;
3. Having visual, language or communication difficulties.

研究实施时间：

Study execute time：

从 From 2021-08-23 00:00:00至 To 2022-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2021-08-23 00:00:00 至 To 2022-02-28 00:00:00

干预措施：

Interventions：

组别：

INTERVENTION

样本量：

 43

Group：

INTERVENTION

Sample size：

干预措施：

MOTIVATIONAL INTERVIEWING AND CONTINGENCY MANAGEMENT

干预措施代码：

Intervention：

MOTIVATIONAL INTERVIEWING AND CONTINGENCY MANAGEMENT

Intervention code：

组别：

Control group

样本量：

 43

Group：

Control group

Sample size：

干预措施：

NO TREATMENT

干预措施代码：

Intervention：

NO TREATMENT

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：

单位(医院)：

 北區醫院 

单位级别：

  

Institution
hospital：

NORTH DISTRICT HOSPITAL

Level of the institution：

测量指标：

Outcomes：

指标中文名：

MEDICATION ADHERENCE

指标类型：

主要指标

Outcome：

MEDICATION ADHERENCE

Type：

Primary indicator

测量时间点：

PRE, IMMEDIATE POST, 3-MONTH POST

测量方法：

MEDICATION ADHERENCE RATE, BRIEF MEDICATION ADHERENCE SCALE

Measure time point of outcome：

PRE, IMMEDIATE POST, 3-MONTH POST

Measure method：

MEDICATION ADHERENCE RATE, BRIEF MEDICATION ADHERENCE SCALE

指标中文名：

PSYCHIATRIC SYMPTOMS

指标类型：

次要指标

Outcome：

PSYCHIATRIC SYMPTOMS

Type：

Secondary indicator

测量时间点：

PRE, IMMEDIATE POST, 3-MONTH POST

测量方法：

BRIEF PSYCHIATRIC RATING SCALE; DEPRESSION, ANXIETY AND STRESS -21

Measure time point of outcome：

PRE, IMMEDIATE POST, 3-MONTH POST

Measure method：

BRIEF PSYCHIATRIC RATING SCALE; DEPRESSION, ANXIETY AND STRESS -21

指标中文名：

SUBSTANCE ABUSE

指标类型：

次要指标

Outcome：

SUBSTANCE ABUSE

Type：

Secondary indicator

测量时间点：

PRE, IMMEDIATE POST, 3-MONTH POST

测量方法：

TIMELINE FOLLOW BACK, URINE TOXICOLOGY, CONTEMPLATION LADDER

Measure time point of outcome：

PRE, IMMEDIATE POST, 3-MONTH POST

Measure method：

TIMELINE FOLLOW BACK, URINE TOXICOLOGY, CONTEMPLATION LADDER

指标中文名：

PSYCHIATRIC HOSPITALIZATION

指标类型：

次要指标

Outcome：

PSYCHIATRIC HOSPITALIZATION

Type：

Secondary indicator

测量时间点：

PRE, IMMEDIATE POST, 3-MONTH POST

测量方法：

TIME OF ADMISSION

Measure time point of outcome：

PRE, IMMEDIATE POST, 3-MONTH POST

Measure method：

TIME OF ADMISSION

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

URINE TOXICOLOGY

组织：

Sample Name：

URINE TOXICOLOGY

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：

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）：

Block randomization with block size of 6-8 will be used to maintain a balanced number of participants in both groups (Efird, 2011). A sequence of group identifiers (I or C) based on computer-generated random codes is prepared in advance and put in serially numbered sealed opaque envelopes by a clerical&

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

Block randomization with block size of 6-8 will be used to maintain a balanced number of participants in both groups (Efird, 2011). A sequence of group identifiers (I or C) based on computer-generated random codes is prepared in advance and put in serially numbered sealed opaque envelopes.

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：

The researcher who is also the intervention deliverer will not know which participant will be assigned to which group before opening of opaque envelope. After allocation has been done, both participants and researcher cannot be blinded.

Blinding：

The researcher who is also the intervention deliverer will not know which participant will be assigned to which group before opening of opaque envelope. After allocation has been done, both participants and researcher cannot be blinded.

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

否No

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）：

Nil

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

NIL

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：

SELF-ADMINISTERED QUESTIONNAIRE WILL BE USED. ALSO, URINE TOXICOLOGY WILL BE SAVED IN EACH POST-INTERVENTION TIME-POINT. All information will be locked in a cabinet and will be only accessible by the research team. All data will then be destroyed five years after completion of the study and publication. Anonymous will be used in publications.

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

SELF-ADMINISTERED QUESTIONNAIRE WILL BE USED. ALSO, URINE TOXICOLOGY WILL BE SAVED IN EACH POST-INTERVENTION TIME-POINT. All information will be locked in a cabinet and will be only accessible by the research team. All data will then be destroyed five years after completion of the study and publication. Anonymous will be used in publications.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2021-08-22 06:17:23
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