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Research for the establishment and effect of training model for diabetes specialist nurses in digestive system surgery based on post competency
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注册号:

Registration number:

ChiCTR2000031852 

最近更新日期:

Date of Last Refreshed on:

2020-04-12 

注册时间:

Date of Registration:

2020-04-12 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

基于岗位胜任力的消化系统外科糖尿病专科护士培训模式构建及效果研究 

Public title:

Research for the establishment and effect of training model for diabetes specialist nurses in digestive system surgery based on post competency 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

基于岗位胜任力的消化系统外科糖尿病专科护士培训模式构建及效果研究 

Scientific title:

Research for the establishment and effect of training model for diabetes specialist nurses in digestive system surgery based on post competency 

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:

唐锐 

研究负责人:

唐锐 

Applicant:

Tang Rui 

Study leader:

Tang Rui 

申请注册联系人电话:

Applicant telephone:

+86 15002591603 

研究负责人电话:

Study leader's telephone:

+86 15002591603 

申请注册联系人传真 :

Applicant Fax:

+86 0931-2687021 

研究负责人传真:

Study leader's fax:

+86 0931-2687021 

申请注册联系人电子邮件:

Applicant E-mail:

55918205@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

55918205@qq.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:

甘肃省兰州市七里河区瓜州路418号 

研究负责人通讯地址:

甘肃省兰州市七里河区瓜州路418号 

Applicant address:

418 Guazhou Road, Qilihe District, Lanzhou, Gansu, China 

Study leader's address:

418 Guazhou Road, Qilihe District, Lanzhou, Gansu, China 

申请注册联系人邮政编码:

Applicant postcode:

730050 

研究负责人邮政编码:

Study leader's postcode:

730050 

申请人所在单位:

甘肃省中医院 

Applicant's institution:

Gansu Provincial Hospital of TCM 

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:

FJ/04-IRB/C/018-V3.0 

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:

甘肃省中医院伦理委员会 

Name of the ethic committee:

Ethics committee of gansu hospital of traditional Chinese medicine 

伦理委员会批准日期:

Date of approved by ethic committee:

2020-03-30 

伦理委员会联系人:

李玉梅 

Contact Name of the ethic committee:

Li Yumei 

伦理委员会联系地址:

甘肃省兰州市七里河区瓜州路418号 

Contact Address of the ethic committee:

418 Guazhou Road, Qilihe District, Lanzhou, Gansu, China 

伦理委员会联系人电话:

Contact phone of the ethic committee:

+86 0931-2687005 

伦理委员会联系人邮箱:

Contact email of the ethic committee:

2650187322@qq.com 

研究实施负责(组长)单位:

甘肃省中医院 

Primary sponsor:

Gansu Provincial Hospital of TCM 

研究实施负责(组长)单位地址:

甘肃省兰州市七里河区瓜州路418号 

Primary sponsor's address:

418 Guazhou Road, Qilihe District, Lanzhou, Gansu, 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):

甘肃

市(区县):

兰州

Country:

China

Province:

Gansu

City:

Lanzhou

单位(医院):

甘肃省中医院

具体地址:

兰州市七里河区瓜州路418号

Institution
hospital:

Gansu Provincial Hospital of TCM

Address:

418 Guazhou Road, Qilihe District

经费或物资来源:

省卫生计生委资助经费1万元,项目承担单位配套经费1万元 

Source(s) of funding:

The provincial commission of health and family planning funds 10,000 yuan, the project unit supporting funds 10,000 yuan 

研究疾病:

糖尿病 

Target disease:

diabetes 

研究疾病代码:

 

Target disease code:

 

研究类型:

卫生服务研究 

Study type:

Health Services Research 

研究所处阶段:

其它 

Study phase:

N/A 

研究目的:

本项目拟运用循证医学方法进行文献检索、系统评价、研究热点分析,经横断面调查、专家咨询,构建基于岗位胜任力的消化系统外科糖尿病专科护士培训体系并制定糖尿病围术期护理路径,通过临床实证研究获得相关数据,为外科血糖护理管理、糖尿病专科护士培训提供参考和借鉴,同时为下一步外科血糖护理管理智能监管软件系统开发提供支持。 

Objectives of Study:

This project intends to use evidence-based medicine method to the research focus, system evaluation and analysis of literature retrieval, the cross-sectional survey, expert consultation, build the digestive system based on position competency surgical diabetes specialist nurse training system and develop diabetes perioperative nursing path, through clinical empirical study access to relevant data, surgical nursing management, blood sugar for diabetes specialist nurse training to provide the reference and reference, at the same time for the next step surgical nursing management blood sugar support intelligent supervision software system development. 

药物成份或治疗方案详述:

对符合纳入标准的围术期2型糖尿病患者按照入院先后顺序分为对照组和干预组,对照组采取普通消化系统外科护士围术期血糖护理管理、院内糖尿病专科护士定期巡查并指导的护理方式,干预组由经过培训的消化系统外科糖尿病专科护士按糖尿病围术期护理路径进行血糖护理管理方式,采集患者一般资料及围术期血糖波动各参数(血糖标准差、日内平均血糖波动幅度、最大血糖波动幅度、日间血糖平均绝对差、低血糖指数)、护士(消化系统外科护士、院内糖尿病专科护士、消化系统外科糖尿病专科护士)糖尿病护理核心指标(理论知识、操作技能)考核、患者满意度等数据。 

Description for medicine or protocol of treatment in detail:

To conform to the inclusion criteria of perioperative patients with type 2 diabetes, according to the order in hospital were divided into control group and intervention group and control group take the common digestive system surgical perioperative nursing management and hospital blood sugar diabetes nurse specialist nurses regularly inspect and guide the way of nursing intervention group by trained and digestive surgery diabetes specialist nurses in diabetes perioperative nursing path for blood sugar management way,Gathering general information and perioperative patients with blood sugar fluctuation parameters (blood glucose standard deviation, days average blood sugar fluctuation, maximum blood sugar fluctuation, daytime blood sugar index of average absolute deviation, low blood sugar), nurses (digestive system surgical nurses, hospital diabetes specialist nurses, digestive surgery diabetes specialist nurses) diabetes care examination (theoretical knowledge, operation skill) core index, patient satisfaction and other data. 

研究设计:

非随机对照试验 

Study design:

Non randomized control 

纳入标准:

(1)患者年龄≥18岁,≤80岁; (2)2型糖尿病患者,其诊断分型符合《中国2型糖尿病防治指南(2017年版)》 ; (3)患者意识清楚,需行消化系统外科手术治疗; (4)知情同意,自愿参加。  

Inclusion criteria

(1) Aged 18 to 80 years old; (2) patients with type 2 diabetes, whose diagnostic classification conforms to the "guidelines for the prevention and treatment of type 2 diabetes in China (2017 edition)"; (3) the patient is clearly conscious and requires surgical treatment of the digestive system; (4) informed consent and voluntary participation. 

排除标准:

(1)严重心、肝、肾功能衰竭者; (2)严重精神疾病; (3)入院前血糖控制不佳或既往频繁发作低血糖史; (4)近 3个月内曾发生急性脑梗死、脑出血或心肌梗死; (5)重症感染期间; (6)因其他疾病正在使用激素等影响血糖控制的药物治疗者; (7)患者及其家属拒绝及时监测血糖。 

Exclusion criteria:

(1) patients with severe heart, liver and kidney failure; (2) serious mental illness; (3) poor blood glucose control before admission or previous history of frequent hypoglycemia; (4) acute cerebral infarction, cerebral hemorrhage or myocardial infarction occurred in the past 3 months; (5) during severe infection; (6) for other diseases, those who are taking drugs such as hormones that affect blood glucose control; (7) patients and their families refuse to timely monitor blood glucose. 

研究实施时间:

Study execute time:

From2020-05-01To 2021-12-31 

干预措施:

Interventions:

组别:

对照组

样本量:

100

Group:

control group

Sample size:

干预措施:

由普通消化系统外科护士负责对入组患者进行围术期全程血糖护理管理(围术期健康宣教、按医嘱血糖监测等),院内糖尿病专科护士定期巡查并指导血糖护理管理。

干预措施代码:

Intervention:

General digestive system surgical nurses were responsible for the perioperative whole blood glucose nursing management of the enrolled patients (health education during the perioperative period, blood glucose monitoring according to the doctor's advice, etc.), and the hospital diabetes specialist nurses made regular inspection

Intervention code:

组别:

试验组

样本量:

100

Group:

experimental group

Sample size:

干预措施:

由经过培训的消化系统外科糖尿病专科护士按照消化外科糖尿病围术期(术前、术中、术后)护理路径负责对入组患者进行围术期全程血糖护理管理(根据患者病情及医嘱规范执行各类降糖药物使用并做好药物使用健康宣教;根据患者血糖监测结果判断血糖控制情况,发现问题及时与外科管床医师、内分泌科会诊医师联系并按照医嘱进行处理;根据患者病情、手术方式、血糖监测数据进行围术期运动量指导及具体饮食选择;负责糖尿病患者伤口管理等)。

干预措施代码:

Intervention:

The trained diabetes specialist nurses of digestive system surgery were responsible for the perioperative blood glucose nursing management of the enrolled patients according to the perioperative (preoperative, intraoperative and postoperative) nursing path of the patients with diabetes in digestive surgery.According to the patient

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

甘肃 

市(区县):

兰州 

Country:

China 

Province:

Gansu 

City:

Lanzhou 

单位(医院):

甘肃省中医院 

单位级别:

三甲医院 

Institution
hospital:

Gansu Provincial Hospital of TCM  

Level of the institution:

Tertiary A Hospital 

测量指标:

Outcomes:

指标中文名:

血糖值

指标类型:

主要指标 

Outcome:

blood glucose

Type:

Primary indicator 

测量时间点:

术前一天到术后三天的血糖

测量方法:

动态血糖仪

Measure time point of outcome:

Measure method:

采集人体标本:

Collecting sample(s)
from participants:

标本中文名:

糖化血红蛋白

组织:

Sample Name:

glycosylated hemoglobin

Tissue:

人体标本去向

其它 

说明

Fate of sample:

Others 

Note:

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 years
最大 Max age 80 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):

由研究者按照入院的先后顺序将患者分为对照组及试验组

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

No. The patients were divided into control group and experimental group according to the order of admission

盲法:

N/A

Blinding:

N/A

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

原始数据公开时间:

The time of sharing IPD:

Real time access

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):

原始数据在试验完成后6个月内公布,上传到临床试验公共管理平台ResMan(www.medresman.org.cn.)

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

The original data will be released within 6 months after completion of the test, It will be upload to Clinical trials of public management platform ResMan(www.medresman.org.cn)

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,电子采集和管理系统

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

Case Report Form and Electronic Data Capture

数据管理委员会:

Data Managemen Committee:

有/Yes

注册人:

Name of Registration:

 2020-04-12
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