视频号科普及八段锦功法对女性结缔组织病患者生活质量影响的随机对照临床研究

注册号:

Registration number:

ITMCTR2024000557

最近更新日期:

Date of Last Refreshed on:

2024-10-14

注册时间:

Date of Registration:

2024-10-14

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

视频号科普及八段锦功法对女性结缔组织病患者生活质量影响的随机对照临床研究

Public title:

A RCT on the effect of video popular science and the "Ba duan Jin" on the quality of life of female patients with connective tissue diseases

注册题目简写:

English Acronym:

研究课题的正式科学名称:

视频号科普及八段锦功法对女性结缔组织病患者生活质量影响的随机对照临床研究

Scientific title:

A RCT on the effect of popular science and the "Ba duan Jin" on the quality of life of female patients with connective tissue diseases

研究课题的正式科学名称简写:

Scientific title acronym:

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:

贺雪

研究负责人:

贺雪

Applicant:

He Xue

Study leader:

He Xue

申请注册联系人电话:

Applicant telephone:

18502139192

研究负责人电话:

Study leader's telephone:

18502139192

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:

hexue_0908@qq.com

研究负责人电子邮件:

Study leader's E-mail:

hexue_0908@qq.com

申请单位网址(自愿提供):

Study leader's website(voluntary supply):

上海市普陀区中心医院风湿免疫科

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:

兰溪路164号

研究负责人通讯地址:

兰溪路164号

Applicant address:

164 Lanxi Road

Study leader's address:

164 Lanxi Road

申请注册联系人邮政编码:

Applicant postcode:

200062

研究负责人邮政编码:

Study leader's postcode:

200062

申请人所在单位:

上海市普陀区中心医院风湿免疫科

Applicant's institution:

上海市普陀区中心医院风湿免疫科

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

PTEC-A-2024-15(S)-1

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

上海市普陀区中心医院(上海中医药大学附属普陀医院)伦理委员会

Name of the ethic committee:

Ethics Committee of Putuo District Central Hospital,Shanghai (Putuo Hospital ,Shanghai University of Traditional Chinese Medicine).

伦理委员会批准日期:

Date of approved by ethic committee:

2024/3/7 0:00:00

伦理委员会联系人:

潘姗姗

Contact Name of the ethic committee:

Pan Shanshan

伦理委员会联系地址:

兰溪路164号

Contact Address of the ethic committee:

164 Lanxi Road

伦理委员会联系人电话:

Contact phone of the ethic committee:

021-22234110

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xlt8171@126.com

研究实施负责(组长)单位:

上海市普陀区中心医院风湿免疫科

Primary sponsor:

Department of Rheumatology and Immunology, Putuo District Central Hospital,Shanghai

研究实施负责(组长)单位地址:

兰溪路164号

Primary sponsor's address:

164 Lanxi Road

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:

中国

Province:

Shanghai

City:

单位(医院):

上海市普陀区中心医院风湿免疫科

具体地址:

兰溪路164号

Institution
hospital:

Department of Rheumatology and Immunology, Putuo District Central Hospital,Shanghai

Address:

164 Lanxi Road

经费或物资来源:

自筹经费

Source(s) of funding:

Self-funded

研究疾病:

结缔组织病

研究疾病代码:

Target disease:

Connective tissue disease

Target disease code:

研究类型:

Study type:

干预性研究

Interventional study

研究设计:

Study design:

随机平行对照

randomized controlled trial(parallel group design)

研究所处阶段:

Study phase:

探索性研究/预试验

Pilot clinical trial

研究目的:

本研究旨在采用单中心随机对照、实效及优效性的临床研究方法,评价视频号科普及八段锦功法对女性结缔组织病患者生活质量的影响。本研究为探索性临床研究,旨在为视频号科普及八段锦功法协助临床治疗效果提供高质量证据。

Objectives of Study:

The purpose of this study was to evaluate the effect of the Channels Science Popularization and Baduan Jingong Method on the quality of life of female patients with connective tissue diseases by using a single-center randomized controlled, effective and effective clinical research method. This study is an exploratory clinical study, aiming to provide high-quality evidence for the clinical treatment effect of the video number science popularization and the Baduan Jingong method.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)年龄18周岁至70周岁,女性; (2)患者确诊为结缔组织病; (3)具有一定的语言交流和学习能力;能够自理、行动方便; (4)患者知情同意,自愿加入本研究。 全部符合以上标准者方可纳入。

Inclusion criteria

(1) Age 18 to 70 years old, female; (2) the patient was diagnosed with connective tissue disease; (3) Have certain language communication and learning ability; Able to take care of themselves and have easy mobility; (3) Patients with informed consent and voluntary participation in this study. Only those who meet the above criteria can be included.

排除标准:

(1)患者不会使用微信; (2)妊娠或哺乳期妇女; (3)卧床,关节基本丧失功能; (4)患者患有严重脏器疾病; (5)合并精神障碍者和无法理解本研究者。 符合以上任意一条即可排除。

Exclusion criteria:

(1) The patient does not know how to use WeChat; (2) pregnant or lactating women; (3) Bedridden, basic loss of joint function; (4) The patient suffers from serious organ diseases; (5) Those with mental disorders and those who are unable to understand the study. Any of the above items can be excluded.

研究实施时间:

Study execute time:

From 2024-11-01

To      2026-08-01

征募观察对象时间:

Recruiting time:

From 2024-11-15

To      2026-05-01

干预措施:

Interventions:

组别:

对照组

样本量:

30

Group:

Control group

Sample size:

干预措施:

常规健康宣教

干预措施代码:

Intervention:

Routine health education

Intervention code:

组别:

视频号科普组

样本量:

30

Group:

Video popular science group

Sample size:

干预措施:

微信视频号科普推送

干预措施代码:

Intervention:

WeChat video popular science push

Intervention code:

组别:

八段锦功法组

样本量:

30

Group:

the "ba duan jin" group

Sample size:

干预措施:

练习八段锦功法

干预措施代码:

Intervention:

Practice the "ba duan jin"

Intervention code:

样本总量 Total sample size : 90

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:

中国

Province:

Shanghai

City:

单位(医院):

上海市普陀区中心医院风湿免疫科

单位级别:

上海市普陀区中心医院风湿免疫科

Institution/hospital:

Department of Rheumatology and Immunology, Putuo District Central Hospital,Shanghai

Level of the institution:

Level 3

测量指标:

Outcomes:

指标中文名:

GAD-7广泛性焦虑障碍量表

指标类型:

主要指标

Outcome:

GAD-7 Generalized Anxiety Disorder Scale

Type:

Primary indicator

测量时间点:

出院后1个月、3个月

测量方法:

根据答题情况的相关得分对患者进行焦虑筛查,0-4分:没有广泛性焦虑障碍,5-9分有轻度广泛性焦虑障碍,10-14分有中度广泛性焦虑障碍,15-21分有重度广泛性焦虑障碍。

Measure time point of outcome:

1 month and 3 months after discharge

Measure method:

Patients were screened for anxiety based on the relevant scores of the answers, with a score of 0-4: no generalized anxiety disorder, 5-9 with mild generalized anxiety disorder, 10-14 with moderate generalized anxiety disorder, and 15-21 with severe generalized anxiety disorder.

指标中文名:

PHQ-9抑郁症筛查量表

指标类型:

主要指标

Outcome:

PHQ-9 Depression Screening Scale

Type:

Primary indicator

测量时间点:

出院后1个月、3个月

测量方法:

根据答题情况的相关得分对患者进行抑郁筛查,0-4分没有抑郁症,5-9分可能有轻微抑郁症,10-14分可能有中度抑郁症,15-19分可能有中重度抑郁症,20-27分可能有重度抑郁症。

Measure time point of outcome:

1 month and 3 months after discharge

Measure method:

Patients were screened for depression based on the relevant scores of the answers, with a score of 0-4 for no depression, 5-9 for mild depression, 10-14 for moderate depression, 15-19 for moderate to severe depression, and 20-27 for major depression.

指标中文名:

短视频健康教育满意度问卷

指标类型:

主要指标

Outcome:

Short video health education satisfaction questionnaire

Type:

Primary indicator

测量时间点:

出院后1个月、3个月

测量方法:

自行设计5个题目的短问卷,了解观察组患者对短视频形式健 康教育的接受度和满意度。内容包括:满意度总体评价(0—10分),视频学习频率和次数,内容是否通俗易懂,是否更加方便学习和理解,是否按照视频内容指导生活。

Measure time point of outcome:

1 month and 3 months after discharge

Measure method:

A short questionnaire with 5 questions was designed to understand the acceptance and satisfaction of the patients in the observation group with health education in the form of short videos. The content includes: overall satisfaction evaluation (0-10 points), the frequency and number of video learning, whether the content is easy to understand, whether it is more convenient to learn and understand, and whether it guides life according to the video

指标中文名:

慢性病患者自我效能量表

指标类型:

主要指标

Outcome:

Self-efficacy scale for patients with chronic diseases

Type:

Primary indicator

测量时间点:

出院后1个月、3个月

测量方法:

采用美国斯坦福大学慢性疾病教育研究中心开发的自我效能量表,包括管理不适症状(如疼痛、乏力等)以及完成自我管理各项任务和活动(如按医嘱服药、营养、控制水盐等)的自我效能共6项,每项以1—10分,1分表示毫无信心,10分表示完全有信心,自我效能得分为各项的总平均分。将得分≥7分定为自我效能水平高,<7分定为自我效能水平低。

Measure time point of outcome:

1 month and 3 months after discharge

Measure method:

The self-efficacy scale developed by the Chronic Disease Education and Research Center of Stanford University in United States was used, including the self-efficacy of managing uncomfortable symptoms (such as pain, fatigue, etc.) and completing various tasks and activities of self-management (such as taking medication according to doctor's instructions, nutrition, water and salt control, etc.), a total of 6 items, each of which was scored on a sc

指标中文名:

SF-36健康量表

指标类型:

主要指标

Outcome:

SF-36 Health Scale

Type:

Primary indicator

测量时间点:

出院后1个月、3个月

测量方法:

SF-36健康调查问卷,调查了包括生理功能、身份角色限制、躯体疼痛、总体健康、活力、社会功能、情感职能、情绪角色限制和健康变化9个维度,共计36个条目。

Measure time point of outcome:

1 month and 3 months after discharge

Measure method:

The SF-36 Health Questionnaire investigated 9 dimensions, including physiological function, identity role limitation, physical pain, general health, vitality, social function, emotional function, emotional role restriction and health change, with a total of 36 items.

指标中文名:

疾病相关知识和行为问卷

指标类型:

主要指标

Outcome:

Disease-related knowledge and behavior questionnaires

Type:

Primary indicator

测量时间点:

出院后1个月、3个月

测量方法:

采用自行设计的问卷进行调查,包括知识和行为2个部分,知识问卷部分共30个题目,疾病基本知识(5题)、治疗和用药(5题)、 饮食(5题)、生活方式(5题)、康复(5题),各项满分均为20分;根据患者对每个条目所陈述的内容判断正误的正确与否计分,判断正确得4 分,判断错误或回答不知道得0分,多选题判断错误不得分,部分正确得2分,得分范围为0~100 分;问卷的Cronbach’s 0c系数为0.72。行为问卷部分调查了解患者在过去半年内的饮食、用药、康复和生活方式等实际行为,问卷采取自答式方式。2 组在基线和干预后均采用此问卷进行测量并进行组间和组内前后比较。

Measure time point of outcome:

1 month and 3 months after discharge

Measure method:

The self-designed questionnaire was used to conduct the survey, including two parts of knowledge and behavior, with a total of 30 questions, basic knowledge of diseases (5 questions), treatment and medication (5 questions), diet (5 questions), lifestyle (5 questions), and rehabilitation (5 questions), with a full score of 20 points. According to the patient's judgment of the correctness or incorrectness of the content stated in each item, 4 point

采集人体标本:

Collecting sample(s)
from participants:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 70
Max age years

Recruiting status:

Participant age:

性别:

Gender:

女性

Female

随机方法(请说明由何人用什么方法产生随机序列):

本试验使用 SPSS 26.0 进行分组。通过SPSS26.0软件生成随机数字表,“1”代表“院内宣教组”,“2”代表“院内宣教+八段锦组”,“3”代表“院内宣教+视频号科普”。将分组结果写在纸条上,放入密闭且不透光的信封中,由专人保管。由一名不知道分组结果的研究者,按照信封编号的顺序,依次打开信封,将患者分配到相应的治疗组,不允许任何人私自更改。本课题严格遵守盲法精神的三分离原则,即观测记录、治疗操作和数据分析三者分开进行。随机分组由专人负责,观测记录由非操作者的研究人员完成,治疗操作根据信封分组执行治疗方案,数据统计和分析由专人负责,以确保临床记录的真实性。

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

This trial was grouped using SPSS 26.0. The random number table is generated by SPSS26.0 software, "1" represents "hospital mission group", "2" represents "hospital mission + Baduanjin group", and "3" represents "hospital mission + video number science popularization". Write down the grouping results on a slip of paper, put them in an airtight and opaque envelope, and keep them in a special person's custody. A researcher who does not know the results of the grouping, in the order of the envelope number, opens the envelope in turn, assigns the patient to the corresponding treatment group, and no one is allowed to change it without permission. This project strictly adheres to the principle of three separations in the spirit of blinding, that is, observation and recording, treatment operation and data analysis are carried out separately. The randomization is in charge of the special person, the observation record is completed by the researcher who is not the operator, the treatment operation is carried out according to the envelope grouping, and the data statistics and analysis are responsible for the special person to ensure the authenticity of the clinical record.

盲法:

Blinding:

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):

将建立研究数据库,且信息保密,如有需要,将隐藏患者信息,提供相关原始数据

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

A study database will be established and the information will be kept confidential, and if necessary, patient information will be hidden and relevant raw data will be provided

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

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

Case Record Form

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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