简体中文|English
检索试验 按国家、省（市）统计 按疾病代码统计 按试验实施单位统计 按试验主办单位统计 按经费或物资来源统计 按征募研究对象情况统计 按注册状态统计 按干预措施统计 按伦理委员会统计 按研究类型统计
基于移动的应用程序在脑卒中居家康复患者中的有效性：一项随机对照试验
下载XML文档

注册号：

Registration number：

 ChiCTR2400089194 

最近更新日期：

Date of Last Refreshed on：

 2024-09-03 16:34:44 

注册时间：

Date of Registration：

 2024-09-03 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

基于移动的应用程序在脑卒中居家康复患者中的有效性：一项随机对照试验

Public title：

Mobile-based applications in stroke Effectiveness in home-based rehabilitation patients: a randomized controlled trial

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于移动的应用程序在脑卒中居家康复患者中的有效性：一项随机对照试验

Scientific title：

Mobile-based applications in stroke Effectiveness in home-based rehabilitation patients: a randomized controlled trial

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：

刘敏 

研究负责人：

刘敏 

Applicant：

Liu Min 

Study leader：

Liu Min 

申请注册联系人电话：

Applicant telephone：

 +86 135 1153 6339

研究负责人电话：

Study leader's
telephone：

+86 135 1153 6339

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：

 hayysjn3k@163.com

研究负责人电子邮件：

Study leader's E-mail：

 hayysjn3k@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：

江苏省淮安市淮安区锦绣江南小区

研究负责人通讯地址：

江苏省淮安市淮安区锦绣江南小区

Applicant address：

Jiangsu Province Huai 'an district, Huai 'an city Jinxiujiangnan community

Study leader's address：

Jiangsu Province Huai 'an district, Huai 'an city Jinxiujiangnan community

申请注册联系人邮政编码：

Applicant postcode：

 223200

研究负责人邮政编码：

Study leader's postcode：

 223200

申请人所在单位：

南京医科大学附属淮安第一人民医院

Applicant's institution：

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

研究负责人所在单位：

南京医科大学附属淮安第一人民医院

Affiliation of the Leader：

The Affiliated Huaian No.1 People's Hospital of Nanjing 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：

 KY-2024-027-01

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：

淮安市第一人民医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of Huai 'an First People's Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-03-15 00:00:00

伦理委员会联系人：

王其龙

Contact Name of the ethic committee：

Wang Qilong

伦理委员会联系地址：

江苏省淮安市淮阴区黄河西路1号

Contact Address of the ethic committee：

1 Huanghe West Road, Huaiyin District, Huai 'an City, Jiangsu Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 158 6171 0352

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：

南京医科大学附属淮安第一人民医院

Primary sponsor：

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

研究实施负责（组长）单位地址：

南京医科大学附属淮安第一人民医院

Primary sponsor's address：

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

江苏

市(区县)：

淮安

Country：

China

Province：

JiangS

City：

单位(医院)：

淮安市第一人民医院

具体地址：

淮安市淮安区锦绣江南小区

Institution
hospital：

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

Address：

1 Huanghe West Road, Huaiyin District, Huai 'an City, Jiangsu Province, China

经费或物资来源：

无

Source(s) of funding：

There is no

研究疾病：

脑卒中  

Target disease：

stroke

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：

本研究目的旨在评价脑卒中居家患者通过移动的应用程序提供康复计划的有效性  

Objectives of Study：

The aim of this study was to evaluate the effectiveness of a rehabilitation program delivered via a mobile app for home-based stroke survivors

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

Inclusion criteria

排除标准：

①合并精神疾病或其他严重躯体疾病；②患者及家属不配合；③患者存在认知功能障碍；④涉及并参与其他研究者；⑤人工气道患者；⑥妊娠期患者；⑦合并吸入性肺炎、关节脱位、骨折等严重并发症。

Exclusion criteria：

① complicated with mental illness or other serious physical diseases; ② Patients and their families did not cooperate; ③ The patient had cognitive dysfunction; ④ involving and participating in other researchers; ⑤ patients with artificial airway; ⑥ pregnant patients; ⑦ Severe complications such as aspiration pneumonia, joint dislocation and fracture were observed.

研究实施时间：

Study execute time：

从 From 2023-04-01 00:00:00至 To 2024-04-01 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-04-02 00:00:00 至 To 2024-04-01 00:00:00

干预措施：

Interventions：

组别：

干预组

样本量：

 66

Group：

Intervention group

Sample size：

干预措施：

1.成立远程护理随访团队 科室成立由由护士主导的远程护理随访团队，小组成员共12名，护士长1名，康复专科护士4名，康复师4名，康复科医生1名，信息工程师1名，心理咨询师1名，团队成员进行统一培训并考核合格后入选。护士长是整个团队的核心及负责人，团队成员进行视频在线会诊，具体分工如下：①专科护士负责病情监测、健康教育实施与评价及其他患者随访工作；②康复师负责患者康复训练，并进行在线纠正指导；③医生负责病情的判断，并发症预防及评估；④信息工程师负责配合护士进行APP模式维护及运行；⑤心理咨询师负责患者康复过程中出现的不配合、逆反等心理问题疏导。 2.制定手机app远程视频会诊联合钉钉打卡上传视频的项目方案 ①建立远程护理QQ小组群：建立居家患者及家属远程护理QQ小组群，发布健康教育视频和健康教育处方。②出院当天评定康复功能、并发症、自理能力、心理状态、满意度评估：a.医生进行并发症评估与诊断，b.康复师评定康复功能(肌力、失语、吞咽），c.心理咨询师评估患者心理状态、d.专科护士评估生活自理能力、满意度。③制定康复计划：康复专科护士联合康复师针对患者存在功能障碍（偏瘫、言语、吞咽）制定康复计划，进行教学培训与考核，直至患者考核合格。④开发app视频会诊：康复专科护士联合信息工程师开发：基于手机米家APP模式下远程视频在线会诊功能。⑤进行视频会诊：以康复专科护士为主的远程随访团队每天在线视频会诊：时间（上午08:30-11:00分,下午14:30-17:00分），共66例患者，分为4组，2名专科护士负责17名患者，2名专科护士负责16名患者组建微信群，负责每天按照规定时间视频在线会诊，督促患者按照计划执行肌力等功能训练。⑥开发钉钉打卡上传视频会诊：负责护士每天钉钉打卡督促上传患者康复视频，康复师要逐一针对患者康复方案进行评价如康复频率、康复训练规范性等，并予培训、点评，直至患者及家属规范执行。⑦复诊评定康复功能、并发症评估、自理能力、心理状态、满意度评估：出院1周患者来院复诊评定，针对居家康复中存在的问题进行个性化康复训练指导，并再次强调患者居家康复的要点；出院1个月、3个月来院复诊评定。 3.干预流程 ①出院前 1天由信息工程师人员协助患者在其手机上完成米家 APP 的安装，并配合患者及家属居家安装360摄像头、视频显示器。并教会患者及家属使用方法。②出院前1天康复专科护士和康复师进行患者偏瘫、失语、吞咽流程培训与考核，患者考核合格。③出院当天康复专科护士协助患者及家属加入远程护理随访QQ小组群，并教会患者及家属按照健康教育视频进行居家康复。④出院当天康复专科护士进行患者康复健康档案建立。⑤干预持续时间从出院当天到患者出院后3个月。

干预措施代码：

Intervention：

1. Establish a telenursing follow-up team The department established a telenuring follow-up team led by nurses, with a total of 12 members, including 1 head nurse, 4 rehabilitation specialist nurses, 4 rehabilitation therapists, 1 rehabilitation doctor, 1 information engineer, and 1 psychological consultant. The team members were selected after unified training and examination. The head nurse is the core and responsible person of the whole team, and the team members conduct video online consultation. The specific division of labor is as follows: ① Specialist nurses are responsible for disease monitoring, health education implementation and evaluation, and other patient follow-up work; ② Rehabilitation therapists were responsible for patients' rehabilitation training, and provided online correction guidance; ③ Doctors are responsible for the judgment of the condition, prevention and evaluation of complications; ④ Information engineers are responsible for the maintenance and operation of APP mode with nurses; ⑤ Psychological counselors are responsible for the counseling of psychological problems such as incooperation and rebellion in the rehabilitation process of patients. 2. Develop a project plan for mobile app remote video consultation combined with nail punching and uploading videos ① Establishment of remote nursing QQ group: establishment of remote nursing QQ group for home patients and their families, release of health education videos and health education prescriptions. ② Assessment of rehabilitation function, complications, self-care ability, psychological state and satisfaction on the day of discharge: a. Complications were assessed and diagnosed by the physician, b. Rehabilitation (muscle strength, aphasia, swallowing) was assessed by the rehabilitator, and c. The psychological status of the patients was evaluated by psychological counselors, and the self-care ability and satisfaction of the patients were evaluated by specialist nurses. ③ Development of rehabilitation plan: rehabilitation specialist nurses and rehabilitation therapists formulated rehabilitation plans for patients with functional disorders (hemiplegia, speech, swallowing), and carried out teaching training and assessment until the patients were qualified. ④ Development of app video consultation: rehabilitation specialist nurses and information engineers developed remote video online consultation based on mobile phone Mijia APP mode. ⑤ Video consultation: daily online video consultation by remote follow-up team mainly composed of rehabilitation specialist nurses: Time (08:30-11:00 am, 14:30-17:00 PM), a total of 66 patients were divided into 4 groups. Two specialist nurses were in charge of 17 patients, and 2 specialist nurses were in charge of 16 patients. ⑥ Development of nailing and clocking and uploading video consultation: Responsible nurses nailing and clocking and uploading patients' rehabilitation videos every day, rehabilitation therapists should evaluate patients' rehabilitation programs one by one, such as rehabilitation frequency and rehabilitation training standardization, and provide training and comments until patients and their families implement the norms. ⑦ Evaluation of rehabilitation function, complications, self-care ability, psychological state and satisfaction: one week after discharge, patients came to the hospital for evaluation of rehabilitation function, individualized rehabilitation training guidance was given according to the problems existing in home rehabilitation, and the key points of home rehabilitation were emphasized again. The patients were followed up at 1 month and 3 months after discharge. 3. Intervention procedures ① One day before discharge, information engineers assisted patients to complete the installation of Mijia APP on their mobile phones, and cooperated with patients and their family members to install 360 camera and video display at home. The patients and their families were taught to use the method. ② One day before discharge, rehabilitation specialist nurses and rehabilitation therapists trained and assessed the patient's hemiplegia, aphasia and swallowing process, and the patient passed the examination. ③ On the day of discharge, rehabilitation specialist nurses assisted patients and their family members to join the telemedicine follow-up QQ group, and taught patients and their family members to carry out home rehabilitation according to the health education video. ④ On the day of discharge, rehabilitation specialist nurses established rehabilitation health records of patients. ⑤ The duration of intervention was from the day of discharge to 3 months after discharge.

Intervention code：

组别：

对照组

样本量：

 66

Group：

Control group

Sample size：

干预措施：

患者采用住院期间执行一系列常规治疗和护理，出院当天由责任护士进行出院健康宣教和书面指导，出院1周内护士进行电话回访，对患者居家护理情况进行询问，并针对患者疑问及时解答指导，出院1个月、3个月分别来院进行复查及随访。

干预措施代码：

Intervention：

The patients were given a series of routine treatment and care during hospitalization, and health education and written guidance were given by the responsible nurses on the day of discharge. The nurses visited the patients by telephone within one week after discharge, inquired about the home care of the patients, and answered the patients' questions in time.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 江苏 

市(区县)：

  

Country：

China

Province：

Jiangsu

City：

单位(医院)：

 南京医科大学附属淮安第一人民医院 

单位级别：

 三甲 

Institution
hospital：

The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University

Level of the institution：

Third class A

测量指标：

Outcomes：

指标中文名：

并发症（吸入性肺炎、关节脱位、骨折）发生率

指标类型：

主要指标

Outcome：

The incidence of complications (aspiration pneumonia, joint dislocation, fracture)

Type：

Primary 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：

主要指标

Outcome：

Muscle strength

Type：

Primary 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：

NA

组织：

Sample Name：

NA

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

结束

/Completed

年龄范围：

Participant age：
最小 Min age 36 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）：

在获得患者的知情同意后，所有符合条件的参与者将被分为男性和女性，因为性别影响结肠镜检查患者的焦虑水平(9)。我们将使用区组大小可变的区组随机化，以1∶1的比例将参与者分配至干预组或对照组。各组的分配顺序将由计算机生成，随机分组将由一名计算机技术人员独立完成。为了隐藏分配结果，小组分配将被放在一个不透明的信封中，参与者分配将由不参与任何研究的独立研究员进行。

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

After obtaining informed consent from the patients, all eligible participants will be categorized into males and females, as gender affects anxiety levels in colonoscopy patients(9). Participants will be assigned to either the intervention group or the control group in a 1:1 ratio using block randomization with variable block sizes. The allocation sequence of the groups will be generated by the computer, and the randomization will be carried out by a computer technician, independent of others. In order to conceal the results of the allocation, group allocations will be placed in an opaque envelope, and participant allocation will be carried out by an independent researcher who is not involved in any part of the study.

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：

由于心理教育干预所需要的条件，不可能对干预人员进行盲化。基线信息和临床访谈在随机分组前收集和进行。数据的管理将由工作人员进行盲化。对结果和得出的结论的统计分析也将采用盲法。试验结果将由独立的统计学家分析，结果将由研究团队解读。

Blinding：

Due to the conditions required for psycho-educational interventions, it is not possible to blind the interventionists. Baseline information and clinical interviews are gathered and conducted prior to randomization. Management of the data will be done by the staff member being blinded. Statistical analysis of the results and resulting conclusions will also be blinded. The trial results will be analyzed by an independent statistician, and the results will be interpreted by the research team.

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）：

2024年6月1日，临床试验公共管理平台，http://www.medresman.org.cn

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

June 1, 2024, ResMan, a public management platform for clinical trials, http://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：

病例记录表和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 Record Form and Electronic Data Capture

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：

  2024-09-03 16:34:35
返回列表
欢迎访问WHO国际临床试验注册平台 Clinical Trials Hong Kong

中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

Copyright(c) (2005 - 2023) Chictr.org.cn.All rights reserved. 中国临床试验注册中心 版权所有

蜀ICP备16010396号-9

提示：推荐使用IE8.0以上版本 宽屏显示分辨率下使用系统