ChiCTR2300071361 版本V1.3 版本创建时间2024/05/31 17:27:00 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2300071361 

最近更新日期：

Date of Last Refreshed on：

 2023-08-04 22:25:12 

注册时间：

Date of Registration：

 2023-05-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Public title：

Developing and testing a brief mindfulness just-in-time adaptive intervention for reducing stress of dementia caregivers

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Developing and testing a brief mindfulness just-in-time adaptive intervention for reducing stress of dementia caregivers

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：

 

研究负责人：

 

Applicant：

Prof CHOU Kee Lee 

Study leader：

Prof CHOU Kee Lee 

申请注册联系人电话：

Applicant telephone：

 +852 2948 7473

研究负责人电话：

Study leader's
telephone：

+852 2948 7473

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：

 klchou@eduhk.hk

研究负责人电子邮件：

Study leader's E-mail：

 klchou@eduhk.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：

研究负责人通讯地址：

Applicant address：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kon

Study leader's address：

The Education University of Hong Kong, 10 Lo Ping Road, B2-1/F-04, Tai Po, Hong Kon

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：

Applicant's institution：

The Education University of Hong Kong

研究负责人所在单位：

Affiliation of the Leader：

The Education University of Hong Kong

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：

 2021-2022-0276

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：

Name of the ethic committee：

The Education University of Hong Kong, Human Research Ethics Committee

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-05-05 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Patsy Chung

伦理委员会联系地址：

Contact Address of the ethic committee：

The Education University of Hong Kong c/o Research and Development Office 10 Lo Ping Road, Tai Po, Hong Kong

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +852 2948 8120

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 hrec@eduhk.hk

研究实施负责（组长）单位：

Primary sponsor：

Research Fund Secretariat, Research Office Health Bureau

研究实施负责（组长）单位地址：

Primary sponsor's address：

Research Fund Secretariat Research Office Health Bureau 9/F, Rumsey Street Multi-storey Carpark Building 2 Rumsey Street, Sheung Wan Hong Kong.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

省(直辖市)：

市(区县)：

Country：

NA

Province：

NA

City：

单位(医院)：

具体地址：

Institution
hospital：

NA

Address：

NA

经费或物资来源：

Source(s) of funding：

Health and Medical Research Fund

研究疾病：

 

Target disease：

Dementia

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：

 其它 

Study phase：

N/A

研究设计：

半随机对照 

Study design：

Quasi-randomized controlled 

研究目的：

 

Objectives of Study：

To determine an effective JITAI decision rule to deliver a brief mindfulness intervention depending the current state of stress of caregivers and to examine if the adaptive model of machine learning algorithm generate higher receptivity of the brief intervention than the static and control model at the end of the four weeks.

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

The inclusion criteria for family dementia caregivers are: 1) aged 18 above, 2) family caregiver of an individual with a confirmed medical diagnosis of any type of dementia who has been residing in the community, 3) having been providing care for ADLs and IADLs for at least 20 hours per week for at least one year prior to recruitment, 4) have a smartphone and 5) have mild to moderate stress (the 14-item Chinese version Perceived Stress Scale).

排除标准：

Exclusion criteria：

1. Having participated in any structured mind-body intervention, cognitive therapy, or structured psychosocial intervention in the 6 months prior to recruitment; 2. Having acute psychiatric and medical comorbidities that are potentially life-threatening (e.g. suicidal ideation) or that limit the caregivers participation or adherence (e.g. acute psychosis).

研究实施时间：

Study execute time：

从 From 2023-08-01 00:00:00至 To 2025-07-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-01-01 00:00:00 至 To 2024-06-30 00:00:00

干预措施：

Interventions：

组别：

样本量：

 75

Group：

1

Sample size：

干预措施：

干预措施代码：

Intervention：

[First phase] In the first phase of the study, participants will be interviewed by our research assistant over the phone with a structural questionnaire in the first day of the study period. Then, they will receive a psycho-education intervention in the first four days. During that period of time, we will also install the wireless ultra-low-power signal system to monitor their stress in their apartment. At the end of the fourth day, the participants will be asked to use the apps we provide for the coming 16 days and they will be given a brief overview of what to expect in the following 16 days of MRT. We will ensure that the sensor system and the EMAs work properly at the end of the first four-day period. In the 16-day MRT (from Day 5 to Day 20), wireless system data will be processed to classify whether the participant’s condition is probably-stressed or probably-not-stressed during each minute of each day. Minutes, stratified by stress classification and time of day, will be randomly allocated to treatment, which involves the delivery of a brief mindfulness intervention prompt or no prompt.

Intervention code：

组别：

样本量：

 120

Group：

2

Sample size：

干预措施：

干预措施代码：

Intervention：

[Second Phase] In the second phase of the proposed study, we will examine the receptivity of the brief mindfulness intervention as we conceptualize the JITAI with six key elements: a distal outcome (stress level), a proximal outcome (engaging in our intervention), decision points (whether the receptivity is high or not), intervention options (whether interventions are delivered or not), tailoring variables (the receptivity), and decision rules. In the first four days, similar to the first phase of the study, participants will be interviewed with a structural questionnaire, then they will receive a four-day psycho-education intervention.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

省(直辖市)：

  

市(区县)：

  

Country：

China

Province：

Hong Kong

City：

单位(医院)：

  

单位级别：

  

Institution
hospital：

Non-governmental Organisations

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

Perceived Stress

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Depressive Symptoms

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Burden

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Positive Aspect of Caregiving

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Sleep Quality

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Quality of Life

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

指标类型：

主要指标

Outcome：

Mindfulness

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

N/A

Tissue：

NA

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

NA

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 100 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）：

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

Minutes, stratified by stress classification and time of day, will be randomly allocated to treatment, which involves the delivery of a brief mindfulness intervention prompt or no prompt. Randomization will only occur if (1) the participant is available (at home and phone battery > 10%); (2) the participant is not overburdened when: (a) he/she has not received an EMA in the last 10 minutes, (b) has not received an intervention prompt in the last hour.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

Blinding：

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）：

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

NA

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

NA

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-05-12 11:40:32