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The impact of companionship mode on acute ischemic stroke rehabilitation patients during the COVID-19 epidemic: a retrospective cohort study
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注册号:

Registration number:

ChiCTR2200055646 

最近更新日期:

Date of Last Refreshed on:

2022-01-15 

注册时间:

Date of Registration:

2022-01-15 

注册号状态:

预注册  

Registration Status:

Prospective registration  

注册题目:

COVID-19疫情期间陪护模式对缺血性脑卒中急性期康复患者的影响:一项回顾性队列研究 

Public title:

The impact of companionship mode on acute ischemic stroke rehabilitation patients during the COVID-19 epidemic: a retrospective cohort study 

注册题目简写:

 

English Acronym:

 

研究课题的正式科学名称:

COVID-19疫情期间陪护模式对缺血性脑卒中急性期康复患者的影响:一项回顾性队列研究 

Scientific title:

The impact of companionship mode on acute ischemic stroke rehabilitation patients during the COVID-19 epidemic: a retrospective cohort study 

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:

宋文娟 

研究负责人:

方凡夫 

Applicant:

wenjuan song 

Study leader:

fanfu fang 

申请注册联系人电话:

Applicant telephone:

15869132934 

研究负责人电话:

Study leader's telephone:

15800719913 

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:

825114235@qq.com 

研究负责人电子邮件:

Study leader's E-mail:

fangfanfu@126.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:

上海市杨浦区长海路168号 

研究负责人通讯地址:

上海市杨浦区长海路168号 

Applicant address:

168 Changhai Road, Yangpu District, Shanghai, China 

Study leader's address:

168 Changhai Road, Yangpu District, Shanghai, China 

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:

上海长海医院 

Applicant's institution:

Shanghai Changhai Hopsital 

是否获伦理委员会批准:

否 

Approved by ethic committee:

NO 

伦理委员会批件文号:

Approved No. of ethic committee:

 

伦理委员会批件附件:

Approved file of Ethical Committee:

批准本研究的伦理委员会名称:

 

Name of the ethic committee:

 

伦理委员会批准日期:

Date of approved by ethic committee:

2013-08-26 

伦理委员会联系人:

 

Contact Name of the ethic committee:

 

伦理委员会联系地址:

 

Contact Address of the ethic committee:

 

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:

上海长海医院 

Primary sponsor:

Shanghai Changhai Hopsital 

研究实施负责(组长)单位地址:

上海市杨浦区长海路168号 

Primary sponsor's address:

168 Changhai Road, Yangpu District, Shanghai, 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):

上海

市(区县):

Country:

china

Province:

shanghai

City:

单位(医院):

上海长海医院

具体地址:

上海市杨浦区长海路168号

Institution
hospital:

Shanghai Changhai Hopsital

Address:

168 Changhai Road, Yangpu District, Shanghai, China

经费或物资来源:

自筹 

Source(s) of funding:

Self-financing 

研究疾病:

缺血性脑卒中 

Target disease:

Ischemic stroke 

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:

回顾性研究 

Study phase:

Retrospective study 

研究目的:

探索不同陪护模式下脑卒中患者并发症发生风险、功能康复及住院费用的差异。 

Objectives of Study:

To explore the differences in the risk of complications, functional rehabilitation and hospitalization costs for stroke patients under different escort models. 

药物成份或治疗方案详述:

 

Description for medicine or protocol of treatment in detail:

 

研究设计:

队列研究 

Study design:

Cohort study 

纳入标准:

①颅脑CT或MRI证实为缺血性脑卒中 ②年龄≥20岁 ③GCS≥12分 ④NIHSS≤15分 ⑤发病病程 1~7天 ⑥住院时间 4~21天 ⑦行保守或溶栓治疗 ⑧住院期间卧床时间≥24小时(卧床是指除外出检查、治疗需要、主动或被动床旁站立或乘坐轮椅外,患者基本活动,如饮食、排泄,均在床上进行。) ⑨住院期间有亲属或护工陪护,未中途更换。 ⑩无转科或转至重症监护室 

Inclusion criteria

① Cerebral CT or MRI confirmed ischemic stroke ② Age ≥ 20 years ③ GCS ≥ 12 points ④ NIHSS ≤ 15 points ⑤ The course of disease was 1 ~ 7 days ⑥ The hospital stay was 4 ~ 21 days ⑦ Conservative or thrombolytic therapy was performed ⑧ The length of stay in bed during hospitalization shall be ≥ 24 hours (bed rest refers to that the basic activities of the patient, such as diet and excretion, are carried out in bed except going out for examination, treatment needs, active or passive standing beside the bed or taking a wheelchair.) ⑨ There were relatives or nursing workers accompanying during hospitalization, and they were not replaced halfway. ⑩ No transfer or transfer to intensive care unit 

排除标准:

①合并脑出血感染性疾病严重的心脏病、心功能不全、呼吸衰竭、肾功能衰竭、肝功能失代偿、恶性肿瘤、消化道出血 ②合并颅内肿瘤、颅脑外伤、动静脉畸形 ③近3月有卒中或重大外伤史 ④患有影响功能恢复的神经或肌肉骨骼疾病 ⑤患有严重的精神疾病 ⑥孕妇或妊娠期 ⑦院前存在肺部感染、泌尿系统感染、急慢性腹泻、压疮、视觉空间缺陷、共济失调、帕金森病等疾病。 

Exclusion criteria:

① combined with cerebral hemorrhage, infectious diseases, severe heart disease, heart failure, respiratory failure, renal failure, decompensated liver function, malignant tumor and gastrointestinal bleeding. ② Combined with intracranial tumor, craniocerebral trauma and arteriovenous malformation ③ Stroke or major trauma in recent 3 months ④ Suffering from neurological or musculoskeletal diseases that affect functional recovery ⑤ Suffering from serious mental illness ⑥ Pregnant women or during pregnancy ⑦ There were pulmonary infection, urinary system infection, acute and chronic diarrhea, pressure ulcer, visual space defect, ataxia, Parkinson's disease and other diseases. 

研究实施时间:

Study execute time:

From2021-10-01To 2022-03-01 

征募观察对象时间:

Recruiting time:

From2022-01-15To 2022-02-28 

干预措施:

Interventions:

组别:

家属陪护组

样本量:

238

Group:

Family care group

Sample size:

干预措施:

家属陪护

干预措施代码:

Intervention:

Family care

Intervention code:

组别:

护工陪护组

样本量:

57

Group:

nursing assistant care group

Sample size:

干预措施:

护工陪护

干预措施代码:

Intervention:

nursing assistant care

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

中国 

省(直辖市):

上海 

市(区县):

 

Country:

china 

Province:

shanghai 

City:

 

单位(医院):

上海长海医院 

单位级别:

三级甲等 

Institution
hospital:

Shanghai Changhai Hopsital  

Level of the institution:

Tertiary A hospital 

测量指标:

Outcomes:

指标中文名:

总并发症

指标类型:

主要指标 

Outcome:

total complications

Type:

Primary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

并发症

指标类型:

次要指标 

Outcome:

complications

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

NIHSS评分

指标类型:

次要指标 

Outcome:

NIHSS score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

Barthel评分

指标类型:

次要指标 

Outcome:

Barthel score

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

肌力

指标类型:

次要指标 

Outcome:

muscle strength

Type:

Secondary indicator 

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

住院费用

指标类型:

次要指标 

Outcome:

Hospital costs

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:

no

组织:

Sample Name:

no

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:

尚未开始

Not yet recruiting

年龄范围:

Participant age:

最小 Min age years
最大 Max age 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):

无随机

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

no random

盲法:

Blinding:

试验完成后的统计结果(上传文件):

Calculated Results ater
the Study Completed(upload file):

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):

单位保留

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

Unit reservation

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:

上海长海医院

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

Shanghai Changhai Hospital

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2022-01-15
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