ChiCTR1900027201 版本V1.0 版本创建时间2019/11/22 09:00:56 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：

 ChiCTR1900027201 

最近更新日期：

Date of Last Refreshed on：

 2019-11-05 09:25:41 

注册时间：

Date of Registration：

 2019-11-05 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

EFFECTIVENESS OF DISTANCE INTEGRATED MANAGEMENT OF CHILDHOOD ILLNESS IN KHYBER PUKHTUNKHWA, PAKISTAN

Public title：

EFFECTIVENESS OF DISTANCE INTEGRATED MANAGEMENT OF CHILDHOOD ILLNESS IN KHYBER PUKHTUNKHWA, PAKISTAN

注册题目简写：

English Acronym：

研究课题的正式科学名称：

EFFECTIVENESS OF dIMCI IN KHYBER PAKHTUNKHWA, PAKISTAN

Scientific title：

EFFECTIVENESS OF dIMCI IN KHYBER PAKHTUNKHWA, PAKISTAN

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：

Prof Dr S. Abrar 

研究负责人：

Prof Dr S. Abrar 

Applicant：

Prof Dr S. Abrar 

Study leader：

Prof Dr S.Abrar 

申请注册联系人电话：

Applicant telephone：

 +92-321-9103569

研究负责人电话：

Study leader's
telephone：

+92-321-9103569

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：

 abrardr@yahoo.com

研究负责人电子邮件：

Study leader's E-mail：

 abrardr@yahoo.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：

Main Swabi-Jehangira Road, Bacha Khan Medical Complex, Shah Mansoor, Ambar Kunda, Swabi, Pakistan

研究负责人通讯地址：

Main Swabi-Jehangira Road, Bacha Khan Medical Complex, Shah Mansoor, Ambar Kunda, Swabi, Pakistan

Applicant address：

Main Swabi-Jehangira Road, Bacha Khan Medical Complex, Shah Mansoor, Ambar Kunda, Swabi, Pakistan

Study leader's address：

Main Swabi-Jehangira Road, Bacha Khan Medical Complex, Shah Mansoor, Ambar Kunda, Swabi, Pakistan

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：

巴基斯坦卫生部

Applicant's institution：

Department of Health, Government of Pakistan

研究负责人所在单位：

巴基斯坦斯瓦比加珠汗医学院社区医学系

Affiliation of the Leader：

Department of Community Medicine, Gajju Khan Medical College, Swabi, Pakistan

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：

 F.No.01-07/2014/PhD

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：

PhD Committee, Health Services Academy, Islamabad

Name of the ethic committee：

PhD Committee, Health Services Academy, Islamabad

伦理委员会批准日期：

Date of approved by ethic committee：

 2019-06-24 00:00:00

伦理委员会联系人：

Dr. Saima Hamid

Contact Name of the ethic committee：

Dr. Saima Hamid

伦理委员会联系地址：

Health Services Academy, Chak shehzad, Islamabad, Pakistan

Contact Address of the ethic committee：

Health Services Academy, Chak shehzad, Islamabad, Pakistan

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +92-51-9255590

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：

Self sponsored

Primary sponsor：

Self sponsored

研究实施负责（组长）单位地址：

Department of Community Medicine, Gajju Khan Medical College Swabi, Pakistan.

Primary sponsor's address：

Department of Community Medicine, Gajju Khan Medical College Swabi, Pakistan.

试验主办单位(项目批准或申办者)：

Secondary sponsor：

经费或物资来源：

Monthly Salary of the Principal Investigator

Source(s) of funding：

Monthly Salary of the Principal Investigator

研究疾病：

患病儿童的远程综合管理  

Target disease：

dIMCI of CHILDHOOD ILLNESS

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：

随机平行对照 

Study design：

Parallel 

研究目的：

1. To evaluate the effectiveness of distance IMCI training regarding improvement in case management skills of health care providers compared to the standard IMCI training; 2. To explore perceptions of health care providers regarding distance and standard IMCI trainings.  

Objectives of Study：

1. To evaluate the effectiveness of distance IMCI training regarding improvement in case management skills of health care providers compared to the standard IMCI training; 2. To explore perceptions of health care providers regarding distance and standard IMCI trainings.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

All the First Level Care Facilities(HCFs) of Abbottabad having at least 4 under-five consultations per day will be included in the study.

Inclusion criteria

All the First Level Care Facilities(HCFs) of Abbottabad having at least 4 under-five consultations per day will be included in the study.

排除标准：

Once, HCFs are identified under inclusion criteria, if there is no Health Care Provider(HCP) or there is a trained HCP in a facility, that facility will be excluded from the study. Informed consent forms will be sent to all eligible HCPs. If ALL eligible HCPs i.e. untrained HCPs of a health facility refuse to participate in the study, that health facility will be excluded from trainings, assessment and analysis but will be reported.

Exclusion criteria：

Once, HCFs are identified under inclusion criteria, if there is no Health Care Provider(HCP) or there is a trained HCP in a facility, that facility will be excluded from the study. Informed consent forms will be sent to all eligible HCPs. If ALL eligible HCPs i.e. untrained HCPs of a health facility refuse to participate in the study, that health facility will be excluded from trainings, assessment and analysis but will be reported.

研究实施时间：

Study execute time：

从 From 2019-07-01 00:00:00至 To 2020-05-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2019-10-01 00:00:00 至 To 2019-10-31 00:00:00

干预措施：

Interventions：

组别：

1

样本量：

 13

Group：

1

Sample size：

干预措施：

dIMCI

干预措施代码：

Intervention：

dIMCI

Intervention code：

组别：

2

样本量：

 13

Group：

2

Sample size：

干预措施：

Standard IMCI

干预措施代码：

Intervention：

Standard IMCI

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 巴基斯坦

省(直辖市)：

 Khyber Pakhtunkhwa 

市(区县)：

 Abbottabad 

Country：

Pakistan

Province：

Khyber Pakhtunkhwa

City：

Abbottabad

单位(医院)：

 Basic Health Units 

单位级别：

 初级卫生保健单位 

Institution
hospital：

Basic Health Units

Level of the institution：

Primary

测量指标：

Outcomes：

指标中文名：

Proportion of correct case management as a result of intervention

指标类型：

主要指标

Outcome：

Proportion of correct case management as a result of intervention

Type：

Primary indicator

测量时间点：

3 months after intervention

测量方法：

Quantitative

Measure time point of outcome：

3 months after intervention

Measure method：

Quantitative

指标中文名：

Perceptions of HCPs

指标类型：

附加指标

Outcome：

Perceptions of HCPs

Type：

Additional indicator

测量时间点：

3 months after intervention

测量方法：

Qualitative

Measure time point of outcome：

3 months after intervention

Measure method：

Qualitative

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

Not Applicable

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：

正在进行

Recruiting

年龄范围：

Participant age：
最小 Min age 25 岁 years
最大 Max age 60 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）：

All eligible health facilities will be entered into a computer software and required number of health facilities i.e. 26 will be selected through simple random sampling by the Principal investigator. Then these facilities will be randomly assigned to TWO equal groups (13+13) using the same software by a sec

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

All eligible health facilities will be entered into a computer software and required number of health facilities i.e. 26 will be selected through simple random sampling by the Principal investigator. Then these facilities will be randomly assigned to TWO equal groups (13+13) using the same software by a sec

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：

Only at the level of evaporators during assessment.Training participants cant be blinded to the type of training.

Blinding：

Only at the level of evaporators during assessment.Training participants cant be blinded to the type of training.

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）：

www.gkmcs.edu.pk

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

www.gkmcs.edu.pk

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：

WHO Health Facility Survey Forms

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

WHO Health Facility Survey Forms

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：

  2019-11-05 09:25:41