今天是:2019-08-22 星期四

以家庭为中心的儿童1型糖尿病个案管理模式的构建及应用
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注册号:

Registration number:

ChiCTR1900023688 

最近更新日期:

Date of Last Refreshed on:

2019-06-07 

注册时间:

Date of Registration:

2019-06-07 

注册号状态:

补注册  

Registration Status:

Retrospective registration  

注册题目:

以家庭为中心的儿童1型糖尿病个案管理模式的构建及应用 

Public title:

Construction and application of family-centered case management model for children with type 1 diabetes  

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

以家庭为中心的儿童1型糖尿病个案管理模式的构建及应用 

Scientific title:

Construction and application of family-centered case management model for children with type 1 diabetes  

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:

王燕 

研究负责人:

吴利平 

Applicant:

WANG Yan 

Study leader:

WU Liping 

申请注册联系人电话:

Applicant telephone:

+86 15761628089 

研究负责人电话:

Study leader's telephone:

+86 13883994594 

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:

940265819@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

wulp312@163.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:

重庆市渝中区中山二路136号 

研究负责人通讯地址:

重庆市渝中区中山二路136号 

Applicant address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

Study leader's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

申请注册联系人邮政编码:

Applicant postcode:

400014 

研究负责人邮政编码:

Study leader's postcode:

400014 

申请人所在单位:

重庆医科大学附属儿童医院 

Applicant's institution:

Children's Hospital of Chongqing Medical University 

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:

(2018)年伦审(研)第(114)号 

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:

重庆医科大学附属儿童医院医学研究伦理委员会 

Name of the ethic committee:

Institution Review Board of Children's Hospital of Chongqing Medical University 

伦理委员会批准日期:

Date of approved by ethic committee:

2018-09-30 

伦理委员会联系人:

张姝 

Contact Name of the ethic committee:

ZHANG Shu 

伦理委员会联系地址:

重庆市渝中区中山二路136号 

Contact Address of the ethic committee:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

 

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:

重庆医科大学附属儿童医院 

Primary sponsor:

Children's Hospital of Chongqing Medical University 

研究实施负责(组长)单位地址:

重庆市渝中区中山二路136号 

Primary sponsor's address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China 

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

中国

省(直辖市):

重庆市

市(区县):

渝中区

Country:

China

Province:

Chongqing

City:

Yuzhong District

单位(医院):

重庆医科大学附属儿童医院

具体地址:

重庆市渝中区中山二路136号

Institution
hospital:

Children's Hospital of Chongqing Medical University

Address:

136 Second Zhongshan Road, Yuzhong District, Chongqing, China

经费或物资来源:

自筹 

Source(s) of funding:

self-raised 

研究疾病:

糖尿病 

Target disease:

diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

观察性研究 

Study type:

Observational study 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

1 规范儿童1型糖尿病临床护理实践,促进专科护理质量提升,为我国大陆地区深入研究与推进个案管理模式提供参考; 2 符合医疗的个性化服务,控制和延缓糖尿病并发症的发生和发展,提高患儿生存质量,减轻家庭经济负担。 

Objectives of Study:

1. Standardize the clinical nursing practice of type 1 diabetes in children, promote the quality of specialized nursing, and provide reference for the in-depth research and promotion of case management mode in mainland China; 2. Provide personalized medical services to control and delay the occurrence and development of diabetes complications, improve the quality of life of children, and reduce the economic burden on families. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

1 符合《中国1型糖尿病诊治指南(2011版)》的诊断标准; 2 年龄2-18岁; 3 患儿及家属自愿参与。 

Inclusion criteria

1. It meets the diagnostic criteria of "China's guidelines for the diagnosis and treatment of type 1 diabetes (2011 edition)"; 2. aged 2-18 years old; 3. The children and their families volunteered to participate. 

排除标准:

1 患有精神疾病不能配合研究者; 2 合并严重的心脑肝肾功能衰竭者; 3 拒绝参与本研究者。 

Exclusion criteria:

1. Patients with mental illness cannot cooperate with researchers; 2. Patients with severe heart, liver, brain and kidney failure; 3. Refuse to participate in the study. 

研究实施时间:

Study execute time:

From2018-09-30To 2019-09-30 

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

常规护理:分阶段根据我院制定的规范实施糖尿病照护

干预措施代码:

Intervention:

Routine nursing: diabetes care was carried out in stages according to the regulations formulated by our hospital

Intervention code:

组别:

观察组

样本量:

30

Group:

Experimental group

Sample size:

干预措施:

在对照组基础上实施以家庭为中心的儿童1型糖尿病个案管理模式

干预措施代码:

Intervention:

The family-centered management model of type 1 diabetes in children was implemented in the control group

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

重庆市 

市(区县):

渝中区 

Country:

China 

Province:

Chongqing 

City:

Yuzhong District 

单位(医院):

重庆医科大学附属儿童医院 

单位级别:

三级甲等儿童医院 

Institution
hospital:

Children's Hospital of Chongqing Medical University  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

糖化血红蛋白

指标类型:

主要指标 

Outcome:

HbA1c

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

空腹血糖

指标类型:

次要指标 

Outcome:

Fasting plasma glucose

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

睡前血糖

指标类型:

次要指标 

Outcome:

Blood sugar before sleeping

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

凌晨血糖

指标类型:

次要指标 

Outcome:

Blood sugar in the morning

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

生存质量

指标类型:

次要指标 

Outcome:

Quality of life

Type:

Secondary 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:

血液

组织:

Sample Name:

blood

Tissue:

人体标本去向

使用后保存 

说明

Fate of sample:

Preservation 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 2 years
最大 Max age 18 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):

根据入院时间分为观察组和对照组,2018年10月至2019年3月入院的患儿为对照组,2019年4月至2019年9月入院的患儿为观察组。

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

N/A

盲法:

N/A

Blinding:

N/A

原始数据公开时间:

The time of sharing IPD:

试验完成后6个月内公开/Within six months after the trial complete

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):

临床试验公共管理平台ResMan (www.medresman.org)

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

ResMan (www.medresman.org)

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:

病例记录表 ResMan

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

Case Record Form, CRF ResMan

数据管理委员会:

Data Managemen Committee:

暂未确定/Not yet

注册人:

Name of Registration:

 2019-06-07
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