ChiCTR2400085947 版本V1.0 版本创建时间2024/06/21 14:13:23 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：

ChiCTR2400085947 

最近更新日期：

Date of Last Refreshed on：

2024-06-21 14:12:55 

注册时间：

Date of Registration：

2024-06-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Public title：

Effectiveness of Telerehabilitation system including mHealth app (ChestCare) and Smart OPEP on knowledge about COPD, self-management, disability, skillsand Quality of life among patients with COPD; a randomised controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Effectiveness of Telerehabilitation system including mHealth app (ChestCare) and Smart OPEP on knowledge about COPD, self-management skills, disability, and Quality of life among patients with COPD; a 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：

 

研究负责人：

 

Applicant：

Suad Ghaben 

Study leader：

Arimi Fitri Mat Ludin 

申请注册联系人电话：

Applicant telephone：

+60 11 6181 6310

研究负责人电话：

Study leader's telephone：

+60 19 603 5978

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：

s.ghaben@Alazhar.edu.ps

研究负责人电子邮件：

Study leader's E-mail：

arimifitri@ukm.edu.my

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：

Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia

Study leader's address：

Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia

申请注册联系人邮政编码：

Applicant postcode：

50300

研究负责人邮政编码：

Study leader's postcode：

50300

申请人所在单位：

Applicant's institution：

Physiotherapy Programme & Center for Healthy Ageing & Wellness, Faculty of Health Sciences (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia

研究负责人所在单位：

Affiliation of the Leader：

Biomedical Science Programme & Center for Healthy Ageing and Wellness (H-CARE), Faculty of Health Sciences, Universiti Kebangsaan Malaysia, Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

UKMPP1/111/8/JEP-2022-561

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：

UKM RESEARCH ETHICS COMMITTEE

伦理委员会批准日期：

Date of approved by ethic committee：

2022-12-01 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

PROFESSOR DR. MOHD SHAHRIR MOHAMED SAID

伦理委员会联系地址：

Contact Address of the ethic committee：

Secretariat UKM Research Ethics Secretariat 1st Floor, Clinical Block, UKM Medical Centre Jalan Yaakob Latiff, Bandar Tun Razak 56000 Cheras, Kuala Lumpur.

伦理委员会联系人电话：

Contact phone of the ethic committee：

+60 3 9145 5046

伦理委员会联系人邮箱：

Contact email of the ethic committee：

sepukm@ukm.edu.my

研究实施负责（组长）单位：

Primary sponsor：

Universiti Kebangsaan Malaysia

研究实施负责（组长）单位地址：

Primary sponsor's address：

Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia

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：

Malaysia

Province：

Kuala Lumpur

City：

Kuala Lumpur

单位(医院)：

具体地址：

Institution
hospital：

University Kebangsaan Malaysia

Address：

Jalan Raja Muda Abdul Aziz, 50300 Kuala Lumpur, Malaysia

经费或物资来源：

Source(s) of funding：

University kebangsaan malaysia

Target disease：

Chronic Obstructive Pulmonary Disorder

Target disease code：

J44. 9

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：

随机平行对照 

Study design：

Parallel 

研究目的：

 

Objectives of Study：

To measure knowledge about COPD, self-management skills, disability, and QoL in patients with COPD who are treated by the telerehabilitation system, including mHealth app (ChestCare) and Smart OPEP.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

The telerehabilitation system, including mHealth app (ChestCare) and the Smart OPEP, was designed to provide patients with COPD with a pulmonary rehabilitation program, thus supporting self-management. Patients and physiotherapists will use the system for eight weeks. where patients will be able to measure their lung volumes independently using the Smart OPEP device. Physiotherapists and patients will be able to interact through the ChestCare mHealth app. The app provides the patients with a basic examination, intervention tools and education required for a pulmonary rehabilitation program. This intervention is expected to enhance patients' knowledge about COPD and its management, self-management skills, disability, and quality of life. *The mHealth app, ChestCare, includes 13 functionalities that provide pulmonary telerehabilitation services to patients with COPD. One function of the app is to measure lung volume using either the smart OPEP or a conventional desk spirometer, which serves as an alternative to the smart OPEP. 

纳入标准：

Inclusion criteria

(1) All adult < 75 years old. (2) Patients with moderate, severe, and very severe stages of COPD; COPD Gold ≥ 2 (3) Stable COPD. (4) Good cognitive functions. (5) Patients who are speaking English

排除标准：

Exclusion criteria：

(1) Peripheral Artery disorders and psychologic disorders or depression (GOLD, 2021) (2) Systemic diseases such as hypertension, diabetes, and cardiovascular disorders (Yohannes, 2014). (3) Patients that have any contraindication to perform spirometry including those younger than 18 years old (Exarchos et al. 2020). (4) Patients who have been discharged from hospital < 3 months prior the study (Lindenauer et al. 2020) (5) Patients with psychological disorders.

研究实施时间：

Study execute time：

从 From 2024-07-01 00:00:00至 To 2024-11-05 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-07-05 00:00:00 至 To 2024-09-05 00:00:00  

干预措施：

Interventions：

组别：

样本量：

75

Group：

intervention group

Sample size：

干预措施：

干预措施代码：

Intervention：

The telerehabilitation system, including the mHealth app (ChestCare) and Smart OPEP allows users to receive an eight-week pulmonary rehabilitation program remotely. The program includes lung volume tracking, symptom examination, an action plan, intervention strategies, an education program, risk factor monitoring, and interaction with physiotherapists.

Intervention code：

组别：

样本量：

75

Group：

Control group

Sample size：

干预措施：

干预措施代码：

Intervention：

Patients will be receiving a conventional pulmonary rehabilitation program: two sessions per week for eight weeks, including symptom examination, breathing exercises, chest clearance techniques, and a physical activity program.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

省(直辖市)：

  

市(区县)：

  

Country：

Malaysia  

Province：

Kuala Lumour 

City：

Kuala Lumpur  

单位(医院)：

 

单位级别：

 

Institution
hospital：

Hospital Canselor Tuanku Muhriz UKM

Level of the institution：

University

测量指标：

Outcomes：

指标中文名：

指标类型：

次要指标

Outcome：

The Chronic Respiratory Disease Questionnaire (CRQ)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline and postintervention

Measure method：

PROM

指标中文名：

指标类型：

次要指标

Outcome：

COPD Knowledge Questionnaire (COPD-KQ)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline and postintervention

Measure method：

PROM

指标中文名：

指标类型：

次要指标

Outcome：

Partner In Health scale (PIH)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline and postintervention

Measure method：

PROM

指标中文名：

指标类型：

次要指标

Outcome：

WHO Disability Assessment Schedule (WHODAS2.0)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline and postintervention

Measure method：

PROM

指标中文名：

指标类型：

次要指标

Outcome：

COPD Assessment test (CAT)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Daily

Measure method：

PROM via mHealth app

指标中文名：

指标类型：

次要指标

Outcome：

Modified Medical Research Council (mMRC)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

weekly

Measure method：

PROM via mHealth app

指标中文名：

指标类型：

主要指标

Outcome：

FEV1

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline, one month follow-up and Postintervention

Measure method：

performance measure

指标中文名：

指标类型：

次要指标

Outcome：

6-minutes walk test

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Baseline and Postintervention

Measure method：

performance measure

指标中文名：

指标类型：

次要指标

Outcome：

The Bode index

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

monthly tracking

Measure method：

..

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

none

Tissue：

none

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

none

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 75 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)：

The sequentially numbered, opaque, sealed envelope (SNOSE) technique will be adopted to allocate the 150 participants to the study and control groups. And those participants will be randomly allocated to the treating physiotherapists.

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：

Assessors will be blinded.

是否共享原始数据：

IPD sharing

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)：

Consideration will be given case by case

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：

1-Collecting data via paper-based format, then, 2- data will be keyed in and stored in Google Drive, where one person has access to the data. with private password access

数据与安全监察委员会：

Data and Safety Monitoring Committee：

暂未确定/Not yet

注册人：

Name of Registration：

  2024-06-21 14:12:55