ChiCTR2400093385 版本V1.0 版本创建时间2024/12/03 17:13:03 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：

 ChiCTR2400093385 

最近更新日期：

Date of Last Refreshed on：

 2024-12-03 17:12:56 

注册时间：

Date of Registration：

 2024-12-03 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

"慢病相对时空"对慢病患者神经内分泌学和生活质量的临床研究

Public title：

Clinical study of "Relative time and space of chronic diseases" on neuroendocrinology and quality of life of patients with chronic diseases

注册题目简写：

English Acronym：

研究课题的正式科学名称：

“慢病相对时空”对慢病患者神经内分泌学和生活质量的临床研究

Scientific title：

Clinical study of "Relative time and space of chronic diseases" on neuroendocrinology and quality of life of patients with chronic diseases

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：

吕海鹏 

研究负责人：

吕海鹏 

Applicant：

Lv Haipeng 

Study leader：

Lv Haipeng 

申请注册联系人电话：

Applicant telephone：

 +86 755 8321 7055

研究负责人电话：

Study leader's
telephone：

+86 755 8321 0755

申请注册联系人传真 ：

Applicant Fax：

 0755 83210755

研究负责人传真：

Study leader's fax：

 0755 83210755

申请注册联系人电子邮件：

Applicant E-mail：

 lvhaipeng8888@163.com

研究负责人电子邮件：

Study leader's E-mail：

 lvhaipeng8888@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：

广东省深圳市福田区北环大道6001号

研究负责人通讯地址：

广东省深圳市福田区北环大道6001号

Applicant address：

6001 Beihuan Avenue, Futian District, Shenzhen City, Guangdong Province

Study leader's address：

6001 Beihuan Avenue, Futian District, Shenzhen City, Guangdong Province

申请注册联系人邮政编码：

Applicant postcode：

 518004

研究负责人邮政编码：

Study leader's postcode：

 518004

申请人所在单位：

广州中医药大学深圳医院(福田)

Applicant's institution：

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

研究负责人所在单位：

广州中医药大学深圳医院(福田)

Affiliation of the Leader：

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

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：

 GZYLL(KY)-2024-100

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：

广州中医药大学深圳医院(福田)医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee, Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-09-12 00:00:00

伦理委员会联系人：

卢琳

Contact Name of the ethic committee：

Lu Lin

伦理委员会联系地址：

广东省深圳市福田区北环大道6001号

Contact Address of the ethic committee：

6001 Beihuan Avenue, Futian District, Shenzhen City, Guangdong Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 153 0298 5815

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 gzyszyyll@126.com

研究实施负责（组长）单位：

广州中医药大学深圳医院(福田)

Primary sponsor：

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

研究实施负责（组长）单位地址：

广东省深圳市福田区北环大道6001号

Primary sponsor's address：

6001 Beihuan Avenue, Futian District, Shenzhen City, Guangdong Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

广东省

市(区县)：

深圳市

Country：

China

Province：

Guangdong Province

City：

Shenzhen City

单位(医院)：

广州中医药大学深圳医院(福田)

具体地址：

广东省深圳市福田区北环大道6001号

Institution
hospital：

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

Address：

6001 Beihuan Avenue, Futian District, Shenzhen City, Guangdong Province

经费或物资来源：

广东省护士协会

Source(s) of funding：

Guangdong Nurses Association

研究疾病：

慢病  

Target disease：

Chronic disease

研究疾病代码：

E10.9 ,I63.9,C

Target disease code：

E10.9 ,I63.9,C

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：

通过随机临床对照研究“慢病相对时空”项目管理对慢病患者神经内分泌学和生活质量的影响，评价慢病患者神经内分泌学激素水平及生活质量变化。根据患者的头发、唾液中皮质醇变化水平、血液中细胞因子-单核细胞β受体敏感性、巨噬细胞极化的变化，评价患者McGill生活质量调查问卷、五个方面的心态问卷FFMQ-适应性调查问卷、心田宽恕量表对患者采取群体性干预及个性化的健康指导干预，提升自我调护能力，增强身体抵抗力，减缓病情进展和并发症发生，提高患者的生活质量。  

Objectives of Study：

To evaluate the changes of neuroendocrinology hormone levels and quality of life in patients with chronic disease through a randomized controlled clinical study on the effects of "chronic disease relative time and space" project management on neuroendocrinology and quality of life in patients with chronic disease. According to the changes of cortisol levels in hair and saliva, cytokine - monocyte β receptor sensitivity in blood, and macrophage polarization of patients, the McGill quality of life questionnaire, the five-aspect mentality questionnaire FFMQ-adaptability questionnaire, and the heart forgiveness Scale were evaluated for group intervention and personalized health guidance intervention. Improve self-care ability, enhance body resistance, slow down disease progression and complications, and improve patients' quality of life.

药物成份或治疗方案详述：

采用临床随机对照研究，对2024年1月—2024年12月在我院治疗后的符合纳入排除标准的慢性病患者 360 例作为研究对象，对照组给予患者常规健康教育管理；观察组给予患者“慢病相对时空”项目管理。研究方案经医学伦理委员会批准，所有患者均对本研究知情并签署同意书，加入该项目研究。 观察 2 组护理前及护理 3 个月后生活质量评分（McGill生活质量调查问卷修订版、五个方面的心态问卷FFMQ-适应性调查问卷、心田宽恕量表）及头发、唾液中的皮质醇，血液中细胞因子-单核细胞β受体敏感性、巨噬细胞极化的变化。 采用 SPSS 22.0 软件对数据进行统计分析，计量资料以均数±标准差（?X±s）表示，组内比较采用配对 t检验，组间比较对差值进行独立样本 t检验。P＜0.05表示差异有统计学意义。 评估两组患者干预前后生活质量评分情况，两组患者干预前后头发、唾液中的皮质醇，血液中细胞因子-单核细胞β受体敏感性、巨噬细胞极化的变化。  

Description for medicine or protocol of treatment in detail：

A randomized controlled clinical study was used to study 360 patients with chronic diseases who met the inclusion and exclusion criteria after treatment in our hospital from January 2024 to December 2024. The control group was given routine health education management. Observation group was given "chronic disease relative time and space" project management. The study protocol was approved by the Medical Ethics Committee, and all patients were informed of the study and signed consent to join the study. The quality of life (QOL) scores (McGill Revised QOL Questionnaire, FFMQ-Adaptive Questionnaire, Heart Forgiveness Scale), cortisol in hair and saliva, cytokine - monocyte β receptor sensitivity in blood, and macrophage polarization were observed before and after 3 months of care in 2 groups. SPSS 22.0 software was used for statistical analysis of the data, and the measurement data were expressed as mean ± standard deviation (?X±s). Paired T-test was used for intra-group comparison, and independent sample T-test was used for inter-group comparison. P < 0.05 indicated that the difference was statistically significant. The quality of life score of two groups of patients before and after intervention was evaluated, and the changes of cortisol in hair and saliva, the sensitivity of cytokine-monocyte β receptor in blood, and the polarization of macrophages in two groups of patients before and after intervention. 

纳入标准：

1.已经被二级及以上医院确诊至少患 1 种慢性病者； 2.病情相对稳定，无精神异常者； 3.有阅读书写能力，可以进行正常沟通者。

Inclusion criteria

1. Those who have been diagnosed with at least one chronic disease by secondary or above hospitals; 2.The condition is relatively stable, no mental abnormalities; 3.Have the ability to read and write, can carry out normal communication.

排除标准：

1.合并严重的肝、肾等重要脏器功能障碍者； 2.正在参加其他研究项目者； 3.因多种原因失访者。所有研究对象均自愿参与本研究，并签署知情同意书。过去4周内使用过皮质类固醇，2个月内服用其他可能干扰SAM或HPA的药物（如口服避孕药、抗生素、抗病毒或抗菌药物）有可能影响参数或本研究的严重精神或身体疾病史，其他可能混淆的情况（如怀孕）。

Exclusion criteria：

1. Patients with severe liver, kidney and other important organ dysfunction; 2. Those who are participating in other research projects; 3. Lost visitors for a variety of reasons. All subjects participated in the study voluntarily and signed informed consent. Use of corticosteroids within the past 4 weeks, other medications within 2 months that may interfere with SAM or HPA (such as oral contraceptives, antibiotics, antiviral or antibacterial drugs) have the potential to affect the parameters or history of serious mental or physical illness in this study, and other conditions that may be confounding (such as pregnancy).

研究实施时间：

Study execute time：

从 From 2024-01-01 00:00:00至 To 2025-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-12-03 00:00:00 至 To 2025-06-26 00:00:00

干预措施：

Interventions：

组别：

观察组

样本量：

 187

Group：

Observation group

Sample size：

干预措施：

观察组给予患者“慢病相对时空”项目管理。“慢病相对时空”，每周五下午活动日百草园固定活动及日常不定期活动。1.聘请专家结合《中国公民健康素养——基本知识与技能（试行）》相关内容对患者进行群体讲座和义诊、培训，使患者具备一定的慢性病知识（主要包括降低各类慢性病发生风险和改善慢性病相关健康状况方面的知识）。2.互动性健康教育：组织群体文体锻炼（八段锦、太极剑、木兰双扇舞、五禽戏、郭林气功、音乐疗法、冥想疗法），借助多媒体软件，发挥图片、影像的作用，同时发放健康手册，为患者讲解慢性病相关知识，规范患者行为（包括加强锻 炼、合理饮食、遵医嘱诊疗、用药、护理、心理指导、康复心得交流和经验介绍等等）。3.批判性健康教育：临床医生和责任护士根据患者的实际情况，纠正患者不规范行为，嘱咐患者家属对患者进行监督，并根据患者病情和兴趣爱好组织合唱团、舞蹈团、朗诵组、太极拳队等，聘请专业老师给予指导；按照患者诉求细分为初级班和中级班，初级班延续往的精华内容，而中级班则引入更深层次、国际认可的替代医学疗法，使患者得到更为细致入微的个性化治疗，深入关怀慢病患者的身心康复。通过“慢病相对时空”管理班组织的各项活动，提高患者的自护能力，改善其生活质量，干预时间为3个月。

干预措施代码：

 MBXDSK

Intervention：

The observation group was given the project management of "relative time and space of chronic diseases". "Chronic disease is relative to time and space", and every Friday afternoon, there are fixed activities and daily irregular activities in the Herbal Garden. 1. Hire experts to give group lectures, free clinics and training to patients in combination with the relevant contents of "China Citizens' Health Literacy-Basic Knowledge and Skills (Trial)", so that patients can have certain knowledge of chronic diseases (mainly including knowledge of reducing the risk of various chronic diseases and improving the health status related to chronic diseases). 2.Interactive health education: organize group sports exercises (Baduanjin, Taiji Sword, Mulan Double Fan Dance, Wuqinxi, Guo Lin Qigong, Music Therapy, Meditation Therapy), give play to the role of pictures and videos with the help of multimedia software, and distribute health manuals at the same time to explain the knowledge about chronic diseases to patients and standardize their behaviors (including strengthening exercise) Exercise, reasonable diet, diagnosis and treatment according to doctor's advice, medication, nursing, psychological guidance, exchange of rehabilitation experience and experience introduction, etc.). ③ Critical health education: clinicians and nurses in charge correct patients' irregular behaviors according to their actual conditions, instruct patients' families to supervise patients, organize choirs, dance troupes, recitation groups and Tai Ji Chuan teams according to patients' conditions and hobbies, and hire professional teachers to give guidance; According to patients' demands, it is divided into primary classes and intermediate classes. The primary classes continue to be the essence, while the intermediate classes introduce deeper and internationally recognized alternative medical therapies, so that patients can get more nuanced personalized treatment and care deeply for the physical and mental rehabilitation of patients with chronic diseases. Through the activities organized by the "chronic disease relative time and space" management class, the self-care ability of patients was improved and their quality of life was improved. The intervention time was 3 months.The observation group was given the project management of "relative time and space of chronic diseases". "Chronic disease is relative to time and space", and every Friday afternoon, there are fixed activities and daily irregular activities in the Herbal Garden. (1) Hire experts to give group lectures, free clinics and training to patients in combination with the relevant contents of "China Citizens' Health Literacy-Basic Knowledge and Skills (Trial)", so that patients can have certain knowledge of chronic diseases (mainly including knowledge of reducing the risk of various chronic diseases and improving the health status related to chronic diseases). ② Interactive health education: organize group sports exercises (Baduanjin, Taiji Sword, Mulan Double Fan Dance, Wuqinxi, Guo Lin Qigong, Music Therapy, Meditation Therapy), give play to the role of pictures and videos with the help of multimedia software, and distribute health manuals at the same time to explain the knowledge about chronic diseases to patients and standardize their behaviors (including strengthening exercise) Exercise, reasonable diet, diagnosis and treatment according to doctor's advice, medication, nursing, psychological guidance, exchange of rehabilitation experience and experience introduction, etc.). 3.Critical health education: clinicians and nurses in charge correct patients' irregular behaviors according to their actual conditions, instruct patients' families to supervise patients, organize choirs, dance troupes, recitation groups and Tai Ji Chuan teams according to patients' conditions and hobbies, and hire professional teachers to give guidance; According to patients' demands, it is divided into primary classes and intermediate classes. The primary classes continue to be the essence, while the intermediate classes introduce deeper and internationally recognized alternative medical therapies, so that patients can get more nuanced personalized treatment and care deeply for the physical and mental rehabilitation of patients with chronic diseases. Through the activities organized by the "chronic disease relative time and space" management class, the self-care ability of patients was improved and their quality of life was improved. The intervention time was 3 months.

Intervention code：

组别：

对照组

样本量：

 187

Group：

Control group

Sample size：

干预措施：

对照组给予患者常规健康教育。即患者出院 2 周内由家庭医生签约团队的护士上门对患者及家属进行单向口头健康教育，内容包括饮食护理、用药指导、运动指导、血糖监测、并发症预防、心理护理等；随访护士分别在患者出院后 1 个月、2 个月、3 个月时，通过微信、电话等形式了解患者的健康状况，并重复进行单向口头健康教育，时间控制在30分钟以内，干预时间为3个月。

干预措施代码：

 CGJKJY

Intervention：

The control group was given routine health education. That is, within 2 weeks after the patient was discharged from the hospital, the nurses of the family doctor's contracted team came to the door to give one-way oral health education to the patient and his family, including diet care, medication guidance, exercise guidance, blood sugar monitoring, complication prevention, psychological care, etc. Follow-up nurses learned about patients' health status through WeChat, telephone and other forms at 1 month, 2 months and 3 months after discharge, and repeated one-way oral health education within 30 minutes, and the intervention time was 3 months.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 广东省 

市(区县)：

 深圳市 

Country：

China

Province：

Gguangdong Province

City：

Shenzhen

单位(医院)：

 广州中医药大学深圳医院(福田) 

单位级别：

 三甲 

Institution
hospital：

Shenzhen Hospital of Guangzhou University of Chinese Medicine (Futian)

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

McGill生活质量调查问卷

指标类型：

主要指标

Outcome：

McGill Quality of Life questionnaire

Type：

Primary indicator

测量时间点：

观察 2 组护理前及护理 3 个月后

测量方法：

问卷调查

Measure time point of outcome：

The two groups were observed before and after 3 months of nursing

Measure method：

Questionnaire survey

指标中文名：

五个方面的心态问卷FFMQ-适应性调查问卷

指标类型：

次要指标

Outcome：

21/5000 Five aspects of the mindset questionnaire FFMQ- Adaptability Questionnaire

Type：

Secondary indicator

测量时间点：

观察 2 组护理前及护理 3 个月后

测量方法：

问卷调查

Measure time point of outcome：

The two groups were observed before and after 3 months of nursing

Measure method：

Questionnaire survey

指标中文名：

心田宽恕量表

指标类型：

次要指标

Outcome：

6/5000 The Heart Forgiveness Scale

Type：

Secondary indicator

测量时间点：

观察 2 组护理前及护理 3 个月后

测量方法：

问卷调查

Measure time point of outcome：

The two groups were observed before and after 3 months of nursing

Measure method：

Questionnaire survey

指标中文名：

头发皮质醇

指标类型：

附加指标

Outcome：

Hair cortisol

Type：

Additional indicator

测量时间点：

观察 2 组护理前及护理 3 个月后

测量方法：

生化检测

Measure time point of outcome：

The two groups were observed before and after 3 months of nursing

Measure method：

Biochemical detection

指标中文名：

唾液皮质醇

指标类型：

附加指标

Outcome：

Salivary cortisol

Type：

Additional indicator

测量时间点：

观察 2 组护理前及护理 3 个月后

测量方法：

生化检测

Measure time point of outcome：

The two groups were observed before and after 3 months of nursing

Measure method：

Biochemical detection

指标中文名：

单核细胞β受体敏感性

指标类型：

附加指标

Outcome：

Monocyte β receptor sensitivity

Type：

Additional indicator

测量时间点：

观察 2 组护理前及护理 3 个月后

测量方法：

生化检测

Measure time point of outcome：

The two groups were observed before and after 3 months of nursing

Measure method：

Biochemical detection

指标中文名：

巨噬细胞极化

指标类型：

附加指标

Outcome：

Macrophage polarization

Type：

Additional indicator

测量时间点：

观察 2 组护理前及护理 3 个月后

测量方法：

生化检测

Measure time point of outcome：

The two groups were observed before and after 3 months of nursing

Measure method：

Biochemical detection

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

头发

组织：

头发

Sample Name：

Hair

Tissue：

Hair

人体标本去向

 使用后销毁  

说明

使用后销毁

Fate of sample：

Destruction after use  

Note：

Destroy after use

标本中文名：

唾液

组织：

唾液

Sample Name：

Saliva

Tissue：

Saliva

人体标本去向

 使用后销毁  

说明

使用后销毁

Fate of sample：

Destruction after use  

Note：

Destroy after use

标本中文名：

血液

组织：

血液

Sample Name：

Blood

Tissue：

Blood

人体标本去向

 使用后销毁  

说明

使用后销毁

Fate of sample：

Destruction after use  

Note：

Destroy after use

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

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

采取随机数字表法对参与试验者进行分组。具体方法：选取随机数字表任意1个数字，自此数字开始截取不重复的374个随机数。按照患者入院的顺序，对应82例患者，将随机数按照从小到大排列，编号从1～187号为试验组，188～374为对照组。

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

The participants were grouped by random number table method. Specific method: Select any 1 number in the random number table, and then intercept 374 random numbers that are not repeated. According to the order of admission, there were 82 patients. Random numbers were arranged in descending order, numbered from 1 to 187 for the experimental group and from 188 to 374 for 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：

单盲；对确定随机数字分组的人设盲

Blinding：

Single-blind; Blinding of people who determine random number groupings

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

否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）：

无

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

None

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, CRF

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：

  2024-12-03 17:12:56