ChiCTR2400085957 版本V1.0 版本创建时间2024/06/21 15:06:39 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：

ChiCTR2400085957 

最近更新日期：

Date of Last Refreshed on：

2024-06-21 15:06:34 

注册时间：

Date of Registration：

2024-06-21 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

基于移动医疗的轻度痴呆老人日常生活活动能力训练方案构建与实证研究

Public title：

Construction and empirical study of a training program for activities of daily living for elderly with mild dementia based on mobile healthcare

注册题目简写：

English Acronym：

研究课题的正式科学名称：

基于移动医疗的轻度痴呆老人日常生活活动能力训练方案构建与实证研究

Scientific title：

Construction and empirical study of a training program for activities of daily living for elderly with mild dementia based on mobile healthcare

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：

薛棉翔 

研究负责人：

陈丽丽 

Applicant：

Mianxiang Xue 

Study leader：

Lili Chen 

申请注册联系人电话：

Applicant telephone：

+86 187 5071 7293

研究负责人电话：

Study leader's telephone：

+86 158 6081 6909

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：

18750717293@163.com

研究负责人电子邮件：

Study leader's E-mail：

qzliy2006@fjmu.edu.cn

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：

福建省福州市台江区交通路88号福建医科大学

研究负责人通讯地址：

福建省福州市鼓楼区东街134号

Applicant address：

Fujian Medical University, No. 88, Jiaotong Road, Taijiang District, Fuzhou City, Fujian Province, China

Study leader's address：

No. 134, East Street, Gulou District, Fuzhou City, Fujian Province, 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：

福建医科大学

Applicant's institution：

Fujian Medical University

研究负责人所在单位：

福建省立医院

Affiliation of the Leader：

Fujian Provincial Hospital

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

K2024-02-012

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：

福建省立医院伦理委员会

Name of the ethic committee：

Ethics Committee of Fujian Provincial Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

2024-02-25 00:00:00

伦理委员会联系人：

练发杨

Contact Name of the ethic committee：

Fayang Lian

伦理委员会联系地址：

福建省福州市鼓楼区东街134号

Contact Address of the ethic committee：

No. 134, East Street, Gulou District, Fuzhou City, Fujian Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 88216023

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：

福建省立医院

Primary sponsor：

Fujian Provincial Hospital

研究实施负责（组长）单位地址：

福建省福州市鼓楼区东街134号

Primary sponsor's address：

No. 134, East Street, Gulou District, Fuzhou City, Fujian Province, 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)：

福建省

市(区县)：

福州市

Country：

China

Province：

Fujian Province

City：

Fuzhou

单位(医院)：

福建省立医院

具体地址：

福建省福州市鼓楼区东街134号

Institution
hospital：

Fujian Provincial Hospital

Address：

No. 134, East Street, Gulou District, Fuzhou City, Fujian Province, China

经费或物资来源：

福建医科大学研究生课题经费

Source(s) of funding：

Funding for Graduate Student Projects at Fujian Medical University

Target disease：

mild dementia

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

了解轻度痴呆老人的日常生活活动能力训练需求，初步构建基于移动医疗适于轻度痴呆老人的日常生活活动能力训练方案，并探讨其可行性，最后评价基于移动医疗的轻度痴呆老人的日常生活活动能力训练方案的应用效果。  

Objectives of Study：

To understand the training needs of the elderly with mild dementia in activities of daily living (ADLs), to construct a preliminary mHealth-based ADL training program for the elderly with mild dementia, to explore the feasibility of the program, and finally to evaluate the application effect of the mHealth-based ADL training program for the elderly with mild dementia.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

纳入标准 ①年龄≥60 岁；②符合WHO国际疾病分类ICD-10中痴呆的诊断标准；③CDR量表评分为1分且结合病史、实验室检查等资料由临床神经内科医师确诊为轻度痴呆的患者；④日常生活活动能力轻度受损，即16分≤ADL<22分；⑤能用普通话进行沟通交流；⑥参与者及家属知情同意且自愿参与本研究，并签署知情同意书。

Inclusion criteria

Inclusion Criteria (i) Age ≥60 years old; (ii) Meet the diagnostic criteria of dementia in the WHO International Classification of Diseases ICD-10; (iii) Patients with a CDR score of 1 and diagnosed with mild dementia by a clinical neurologist in conjunction with medical history and laboratory tests; (iv) Mildly impaired in the ability to carry out activities of daily living (i.e., 16 ≤ ADL < 22); (v) Able to communicate in Putonghua; (vi) Informed consent and voluntary participation in this study by the participant and family members; and (vii) Signed informed consent. agreed and voluntarily participated in this study and signed an informed consent form.

排除标准：

排除标准 ①患有严重的心血管疾病、恶性肿瘤等重大躯体疾病；②有严重的视听障碍，无法进行沟通；③患有酒精中毒史、药物成瘾史，或脑外伤、脑血管疾病、脑炎、癫痫、帕金森等可能引起认知障碍的神经系统疾病；④有严重肢体功能障碍；⑤独居老人。

Exclusion criteria：

Exclusion Criteria ① Suffering from serious cardiovascular diseases, malignant tumors and other major physical diseases; ② Having serious visual and auditory impairments that prevent them from communicating; ③ Suffering from a history of alcoholism, drug addiction, or neurological disorders such as traumatic brain injury, cerebrovascular disease, encephalitis, epilepsy, Parkinson's disease and other neurological disorders that may cause cognitive disorders; ④ Having serious physical dysfunction; ⑤ Elderly people who live alone.

研究实施时间：

Study execute time：

从 From 2024-02-29 00:00:00至 To 2024-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2024-06-30 00:00:00 至 To 2024-10-31 00:00:00  

干预措施：

Interventions：

组别：

对照组

样本量：

38

Group：

control group

Sample size：

干预措施：

对照组不提供日常生活活动能力微信小程序的训练，仅提供常规的健康教育：创建微信群，在微信群中提供健康教育相关知识，为患者及家属及时解答疑惑，鼓励患者之间进行经验交流。

干预措施代码：

Intervention：

The control group does not provide the training of daily living activities ability WeChat mini-program, and only provides routine health education: creating WeChat groups, providing health education related knowledge in WeChat groups, answering questions for patients and their families in a timely manner, and encouraging the exchange of experience among patients.

Intervention code：

组别：

试验组

样本量：

38

Group：

experimental group

Sample size：

干预措施：

试验组在对照组的基础上进行日常生活活动能力训练的干预，该组结合患者线上训练、线下实践，照护者线下监督汇报的模式进行干预。试验组每周在照护者监督下使用日常生活活动能力训练微信小程序进行 3 次日常生活活动能力的干预，每次半小时到一小时。训练过后在微信群进行接龙打卡，未在规定时间内进行学习的患者打电话进行询问，提醒其学习。每次线上训练过后，患者在线下进行训练模块的实践，该过程由照护者监督并以录制视频或拍摄图片等形式汇报在微信群中，进行打卡。每个月电话随访，训练时长为 12 周，第 12 周来院回访，评估研究对象的日常生活活动能力、认知状况、及居家训练状况，录入个人健康档案中。与研究对象分析现存问题，并与其共同制定行为改变计划，以便于干预结束后还能继续坚持训练。干预结束后 12周通过电话、微信、上门等方式进行随访，了解患者认知康复情况，嘱家属进行监督。

干预措施代码：

Intervention：

The experimental group carried out the intervention of activities of daily living ability training on the basis of the control group, which combined the patients' online training, offline practice, and offline supervision and debriefing by the caregiver. The experimental group was supervised by the caregiver every week.The experimental group used the WeChat program for activities of daily living (ADL) training three times a week under the supervision of the caregiver, each time for half an hour to one hour. Each intervention lasted from half an hour to one hour. After the training, the patients were asked to play cards in the WeChat group, and those who did not study within the specified time were called to remind them to study. Patients who did not study within the prescribed time were called to inquire and reminded to study. After each online training session, patients practiced the training modules offline. The process is supervised by the caregiver and reported in the WeChat group in the form of recording videos or taking pictures for clocking in. Monthly .The patients were followed up by telephone every month for 12 weeks, with a return visit to the hospital in the 12th week to assess their ability to perform activities of daily living, cognitive status, and home health. At the twelfth week, we came back to the hospital to assess the participants' ability to perform activities of daily living, their cognitive status, and the status of their home training, and recorded them in their personal health records. We analyzed the existing problems with the participants and worked out a behavioral change plan with them. We will analyze the existing problems with the participants and work out a behavioral change plan with them so that they can continue the training after the intervention. 12 weeks after the end of the intervention. After 12 weeks of the intervention, the patients were followed up by telephone, WeChat, and home visits to learn about their cognitive recovery, and their families were asked to supervise them.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 福建省 

市(区县)：

 福州市 

Country：

China 

Province：

Fujian Province 

City：

Fuzhou 

单位(医院)：

福建省立医院 

单位级别：

三甲 

Institution
hospital：

Fujian Provincial Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

日常生活活动能力

指标类型：

主要指标

Outcome：

Activities of Daily Living (ADLs)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

整体认知功能

指标类型：

次要指标

Outcome：

Overall cognitive function

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生活质量

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：

指标中文名：

特定认知域

指标类型：

次要指标

Outcome：

specific cognitive domain

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：

无

组织：

Sample Name：

None

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：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 60 岁 years
最大 Max age 80 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）：

全部研究对象招募完成后，将符合纳入、排除标准且完成知情同意程序的患者按照试验组和对照组以 1:1 的配比进行随机分组。

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

After all study subjects were recruited, patients who met the inclusion and exclusion criteria and completed the informed consent procedure were randomized in a 1:1 ratio between the test group and the control group.

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：

考虑到在开展日常生活活动训练干预活动时较难对干预者和研究对象设盲，因此本研究仅对资料评估调查者和统计分析人员实施盲法。

Blinding：

Considering that it is more difficult to blind the intervener and the study participants when carrying out activities of daily living training intervention activities, this study only blinded the data assessment investigator and the statistical analyst.

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

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）：

我们将以论文的形式公布试验方案，有需要原始数据的科研工作者可以通过联系通讯作者获得。

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

We will publish the experimental protocol in the form of a paper, and researchers who need the raw data can obtain it by contacting the corresponding authors

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：

由经过专门培训的资料收集员对数据进行测量和采集。采用Excel 2016建立数据库，为保证数据录入的准确性，所有数据均双人录入；采用SPSS软件进行数据处理。

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

Data were measured and collected by specially trained data collectors. Excel 2016 was used to create the database and all data were entered in pairs to ensure accuracy of data entry; SPSS software was used for data processing.

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：

  2024-06-21 15:06:34