ChiCTR2300077632 版本V1.0 版本创建时间2023/11/14 16:58:15 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：

ChiCTR2300077632 

最近更新日期：

Date of Last Refreshed on：

2023-11-14 16:57:53 

注册时间：

Date of Registration：

2023-11-14 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

Public title：

Evaluating impact of digital support aided intervention in patient wit uncontrolled diabetes mellitus

注册题目简写：

English Acronym：

研究课题的正式科学名称：

Scientific title：

Evaluating impact of digital support aided intervention on diabetes management in patient wit uncontrolled diabetes mellitus; A step towards e-health for chronic illbesses

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：

Mahpara laiq 

Study leader：

Dr Imran Masood 

申请注册联系人电话：

Applicant telephone：

+92 302 7874430

研究负责人电话：

Study leader's telephone：

+92 349 6744557

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：

mahparalaiq148@gmail.com

研究负责人电子邮件：

Study leader's E-mail：

drimranmasood@gmail.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：

研究负责人通讯地址：

Applicant address：

Khawaja Fareed campus Islamia university Bahawalpur

Study leader's address：

Khawaja Fareed campus Islamia university Bahawalpur

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：

Islamia university Bahawalpur

研究负责人所在单位：

Affiliation of the Leader：

Islamia university Bahawalpur

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：

169-2023-/PHEC

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：

Pharmacy research ethics committee

伦理委员会批准日期：

Date of approved by ethic committee：

2023-02-10 00:00:00

伦理委员会联系人：

Contact Name of the ethic committee：

Dr. Naveed Akhtar

伦理委员会联系地址：

Contact Address of the ethic committee：

Department of pharmacy, Khawaja Fareed Campus, Railway Road, The Islamia University Bahawalpur, Bahawalpur-Punjab Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

+92 62 9255565

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：

Primary sponsor：

The Islamia University Bahawalpur

研究实施负责（组长）单位地址：

Primary sponsor's address：

Khawaja Fareed Campus, Railway Road, The Islamia University Bahawalpur, Bahawalpur-Punjab Pakistan

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：

Pakistan

Province：

Punjab

City：

Bahawalpur

单位(医院)：

具体地址：

Institution
hospital：

The Islamia University of Bahawalpur

Address：

Khawaja Fareed Campus, Railway Road, The Islamia University Bahawalpur, Bahawalpur-Punjab Pakistan

经费或物资来源：

Source(s) of funding：

self funded

Target disease：

Diabetes

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：

随机平行对照 

Study design：

Parallel 

研究目的：

 

Objectives of Study：

To access the impact of digital support aided intervention on diabetes knowledge of diabetic patients. To evaluate the impact of digital support aided intervention on adherence of diabetic patients to medication therapy. To identify the impact of digital support aided intervention on glycemic(HBA1C) level of diabetic patient. To access how individual counselling can effect self-efficacy of diabetic patient to control their disease. To access the impact of digital support aided intervention on health related quality of life (HRQOL of diabetic patients.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

Research pharmacist will provide diabetes care information to every patient & his her caregiver in the form of infographics via mobile applications. the information in infographics will based on "standard of Medical Care 2018". the content of education strategy will consist of 6 main season: (1) Diabetes knowledge( e.g., symptoms, target blood glucose level, complications); (2) Self medication practices (e.g., healthy diet, physical activity, foot care); (3) Pharmacological therapy (e.g., medication regimen, adherence to medication, Adverse drug reactions); (4) common co-morbidities & management (e.g., Hypertension, dyslipidemia; (5) motivating family care giver to help patients in diabetes care; (6) reminder of medication taking. Research pharmacist will deliver 3-5 infographics on diabetes education every day ( Monday-Sunday, with no holidays) for six months. Additionally, medication reminder in short text messages will be distributed three times a day: 6am, 12pm & 6pm. After that the feed back of patient will directly be tailored to questionnaire. 

纳入标准：

Inclusion criteria

patients having age >18 years Patient having diagnosis of type 2 diabetes Patient having inadequate diabetes control Patient is the receipt of anti-glycemic agent be able to participate in study by using mobile application Patients (who are unable to respond) having family member as a caregiver. the characteristics of caregiver are; (a) having age >18 years (b) is a spouse child or relative of patient (c) own a smart phone & able to use it (d) be able to participate in study by using mobile application.

排除标准：

Exclusion criteria：

Patient will be excluded if they will confused, unwilling to participate or complete the study.

研究实施时间：

Study execute time：

从 From 2023-11-15 00:00:00至 To 2024-06-15 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2023-11-15 00:00:00 至 To 2023-12-15 00:00:00  

干预措施：

Interventions：

组别：

样本量：

120

Group：

Group 1

Sample size：

干预措施：

干预措施代码：

Intervention：

monitoring through mobile application

Intervention code：

组别：

样本量：

120

Group：

Group 2

Sample size：

干预措施：

干预措施代码：

Intervention：

monitoring through mobile application + patient counselling

Intervention code：

组别：

样本量：

120

Group：

Group 3

Sample size：

干预措施：

干预措施代码：

Intervention：

monitoring through mobile application + patient counselling + caregiver counselling

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

省(直辖市)：

  

市(区县)：

  

Country：

Pakistan 

Province：

Punjab 

City：

Bahawalpur 

单位(医院)：

 

单位级别：

 

Institution
hospital：

Bahawal Victoria Hospital

Level of the institution：

tertiary care

测量指标：

Outcomes：

指标中文名：

指标类型：

主要指标

Outcome：

glycemic control ( HbA1C)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline, after three months, after six months

Measure method：

Blood test,

指标中文名：

指标类型：

主要指标

Outcome：

diabetes knowledge

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline, after three months, after six months

Measure method：

Questionnaire

指标中文名：

指标类型：

主要指标

Outcome：

health related quality of life

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline, after three months, after six months

Measure method：

Questionnaire

指标中文名：

指标类型：

主要指标

Outcome：

adherence

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline, after three months, after six months

Measure method：

Questionnaire

指标中文名：

指标类型：

主要指标

Outcome：

patient self efficacy rate

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

baseline, after three months, after six months

Measure method：

Questionnaire

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

组织：

Sample Name：

blood sample

Tissue：

vein

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

HbA1C test

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 65 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)：

A computer based randomization list is generated & participants are allocated into the control & intervention groups accordingly.

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：

Blinding：

Single blind

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

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）：

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

Data set

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：

Data will be collected from the patient through standard questionnaires. TO check HBA1C sample of blood will be taken directly from the patient through syringe.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-11-14 16:57:53