ChiCTR2400087875 版本V1.0 版本创建时间2024/08/06 14:44:37 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：

 ChiCTR2400087875 

最近更新日期：

Date of Last Refreshed on：

 2024-08-06 14:44:32 

注册时间：

Date of Registration：

 2024-08-06 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

农村高血压患者自我管理行为干预模式

Public title：

Intervention Model for Self-Management Behavior of Hypertensive Patients in Rural Areas

注册题目简写：

English Acronym：

研究课题的正式科学名称：

医患互动视角下农村高血压患者自我管理行为的自适应干预模式的构建与验证

Scientific title：

Construction and Verification of Adaptive Intervention Model for Self-Management Behavior of Hypertensive Patients in Rural Areas:A Perspective of Doctor-Patient Interactions

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：

吴玉菊 

研究负责人：

吴玉菊 

Applicant：

Yuju Wu 

Study leader：

Yuju Wu 

申请注册联系人电话：

Applicant telephone：

 +86 183 8209 6899

研究负责人电话：

Study leader's
telephone：

+86 183 8209 6899

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：

 yujuwu@scu.edu.cn

研究负责人电子邮件：

Study leader's E-mail：

 yujuwu@scu.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：

四川省成都市武侯区人民南路三段16号

研究负责人通讯地址：

四川省成都市武侯区人民南路三段16号

Applicant address：

No.16, Section 3, Renmin South Road, Wuhou District, Chengdu, Sichuan, China

Study leader's address：

No.16, Section 3, Renmin South Road, Wuhou District, Chengdu, Sichuan, China

申请注册联系人邮政编码：

Applicant postcode：

 610041

研究负责人邮政编码：

Study leader's postcode：

 610041

申请人所在单位：

四川大学/华西公共卫生学院健康行为与社会医学系

Applicant's institution：

Department of Health Behaviour and Social Medicine, Sichuan University/West China School of Public Health (West China Fourth Hospital)

研究负责人所在单位：

四川大学/华西公共卫生学院健康行为与社会医学系

Affiliation of the Leader：

Department of Health Behaviour and Social Medicine, Sichuan University/West China School of Public Health (West China Fourth Hospital)

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：

 Gwll2024130

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：

四川大学华西第四医院/华西公共卫生学院伦理委员会

Name of the ethic committee：

Ethics Committee of West China Fourth Hospital and West China School of Public Health, Sichuan University

伦理委员会批准日期：

Date of approved by ethic committee：

 2024-05-10 00:00:00

伦理委员会联系人：

熊围

Contact Name of the ethic committee：

Wei Xiong

伦理委员会联系地址：

四川省成都市武侯区人民南路三段16号

Contact Address of the ethic committee：

No.16, Section 3, Renmin South Road, Wuhou District, Chengdu, Sichuan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 28 8550 8845

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：

四川大学华西公共卫生学院

Primary sponsor：

West China School of Public Health, Sichuan University

研究实施负责（组长）单位地址：

四川省成都市武侯区人民南路三段16号

Primary sponsor's address：

No.16, Section 3, Renmin South Road, Wuhou District, Chengdu, Sichuan, 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)：

四川

市(区县)：

成都

Country：

China

Province：

Sichuan

City：

Chengdu

单位(医院)：

四川大学华西公共卫生学院

具体地址：

四川省成都市武侯区人民南路三段16号

Institution
hospital：

West China School of Public Health, Sichuan University

Address：

No.16, Section 3, Renmin South Road, Wuhou District, Chengdu, Sichuan, China

经费或物资来源：

国家自然科学基金

Source(s) of funding：

National Natural Science Foundation of China (NSFC)

研究疾病：

高血压  

Target disease：

hypertension

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：

依托农村高血压随访管理，从医患互动视角动态构建改善农村高血压患者自我管理行为的自适应干预模式，并检验各干预类型组合的效果，筛选最优组合，建立促进农村高血压患者自我管理行为的可持续性干预模式。  

Objectives of Study：

Relying on the follow-up management of rural hypertension, we dynamically constructed an adaptive intervention model to improve the self-management behaviour of rural hypertensive patients from the perspective of doctor-patient interaction, and examined the effects of combinations of intervention types.Adaptive intervention model to improve self-management behaviour of rural hypertensive patients, and test the effect of each combination of intervention types and screen the optimal combination.Establishing a sustainable intervention model to promote self-management behaviours in rural hypertensive patients.

药物成份或治疗方案详述：

在正式开展干预性研究前，本研究先开展基线调查，了解农村地区高血压患者自我管理行为的特征及其关键影响因素，进而形成符合农村高血压患者的干预模式，然后开展为期一年的干预性研究， 

Description for medicine or protocol of treatment in detail：

In this study, a baseline survey was conducted before the formal start of the intervention study to understand the characteristics of self-management behaviors of hypertensive patients in rural areas and their key influencing factors, which in turn led to the development of an intervention model that is consistent with the rural hypertensive patients, followed by a one-year intervention study. 

纳入标准：

本研究的研究对象包括农村高血压随访管理的医患双方。 医方是指乡镇卫生院或村卫生室开展高血压随访管理的医生。纳入标准为：①目前正在开展高血压随访管理工作；②愿意参与本研究项目；③未来一年内无工作调整计划。 患方是指农村地区接受随访管理的高血压患者。纳入标准为：①常住在农村地区的确诊高血压患者；②未来一年无长期外出计划；③愿意参与本研究项目；④无认知障碍；⑤无其他影响自我管理行为的疾病，如恶性肿瘤等。

Inclusion criteria

The research population of this study included both the doctor and patient sides of rural hypertension follow-up management. The medical side is defined as the doctor who carries out hypertension follow-up management in the township health centre or village health office. The inclusion criteria were: (1) currently carrying out hypertension follow-up management; (2) willing to participate in this research project; and (3) no work adjustment plan in the next year. The affected parties are the hypertensive patients who receive follow-up management in rural areas. The inclusion criteria were: ① diagnosed hypertensive patients usually residing in rural areas; ② no long-term plan to go out in the next year; ③ willing to participate in this research project; ④ no cognitive impairment; ⑤ no other diseases affecting self-management behaviours, e.g., malignant tumours.

排除标准：

医方：①未来一年内有工作调整计划；②经充分解释仍拒绝参与本研究项目； 患方：①非常住在农村地区的确诊高血压患者；②有其他影响自我管理行为的疾病，如恶性肿瘤等；③患有精神疾病或智力缺陷④经充分解释仍拒绝参与本研究项目。

Exclusion criteria：

Medical: (1) have a plan to adjust their work within the next year; (2) refuse to participate in the study even after a full explanation; Patients: ① confirmed hypertensive patients who very much live in rural areas; ② have other diseases that affect self-management behaviour, such as malignant tumours; ③ suffer from psychiatric diseases or mental deficiencies ④ refuse to participate in this research project even after a full explanation.

研究实施时间：

Study execute time：

从 From 2024-07-01 00:00:00至 To 2026-12-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-08-15 00:00:00 至 To 2024-09-30 00:00:00

干预措施：

Interventions：

组别：

标准互动干预组

样本量：

 160

Group：

Standard Interactive Intervention Group

Sample size：

干预措施：

由随访医生在随访管理中开展的医患互动干预，每 3 个月开展一次。 干预内容：根据健康行为互动模式设计干预内容，包括健康信息（自我管理行为欠佳的潜在危险等）、专业技能（血压测量、用药指导等）、情感支持（高血压患者感受等）和决策参与（根据患者自身情况共同设定改善自我管理行为的目标等）四个方面的干预内容。干预内容在经过研究团队讨论和专家指导后，形成统一的标准化文本内容框架，以便随访管理医生按照统一标准执行互动干预内容。干预不会对患者造成任何伤害。

干预措施代码：

Intervention：

Patient-doctor interaction interventions in follow-up management by follow-up physicians, every 3 months. Intervention content: The intervention content was designed according to the health behaviour interaction model, including four aspects of health information (potential risks of poor self-management behaviours, etc.), professional skills (blood pressure measurement, medication guidance, etc.), emotional support (feelings of hypertensive patients, etc.), and decision-making participation (joint setting of goals to improve self-management behaviours according to the patient's own situation, etc.). The content of the intervention was discussed by the research team and guided by experts to form a unified and standardised text content framework, so that the follow-up management doctors can implement the interactive intervention content according to the unified standard. The intervention will not cause any harm to patients.

Intervention code：

组别：

强化互动干预组

样本量：

 160

Group：

Intensive Interactive Intervention Group

Sample size：

干预措施：

强化互动干预是指 标准互动干预后，采用电话互动增加干预频次，其中电话互动是在没有实施标准 互动干预的月份，每月通过电话开展 1 次简短互动干预。干预内容与标准组相同。

干预措施代码：

Intervention：

Intensive interactive interventions are The standard interactive intervention was followed by an increased frequency of interventions using telephone interactions, where telephone interactions were conducted 1 time per month by telephone in months where the standard interactive intervention was not implemented. telephone interaction was 1 brief interactive intervention by telephone per month in the months when the standard interactive intervention was not implemented. The content of the intervention was the same as in the standard group.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

 仪陇县 

Country：

China

Province：

Sichuan

City：

Yilong

单位(医院)：

 无 

单位级别：

 无 

Institution
hospital：

none

Level of the institution：

none

测量指标：

Outcomes：

指标中文名：

高血压患者自我管理行为

指标类型：

主要指标

Outcome：

Self-management behaviours in hypertensive patients

Type：

Primary indicator

测量时间点：

测量方法：

问卷调查法

Measure time point of outcome：

Measure method：

Questionaire survey

指标中文名：

舒张压

指标类型：

主要指标

Outcome：

Diastolic blood pressure

Type：

Primary indicator

测量时间点：

测量方法：

血压计现场测量

Measure time point of outcome：

Measure method：

Sphygmomanometer on-site measurement

指标中文名：

收缩压

指标类型：

主要指标

Outcome：

Systolic blood pressure

Type：

Primary indicator

测量时间点：

测量方法：

血压计现场测量

Measure time point of outcome：

Measure method：

Sphygmomanometer on-site measurement

指标中文名：

高血压自我管理知识

指标类型：

次要指标

Outcome：

Self-management knowledge in hypertensive patients

Type：

Secondary indicator

测量时间点：

测量方法：

问卷调查法

Measure time point of outcome：

Measure method：

Questionaire survey

指标中文名：

高血压随访管理服务利用

指标类型：

次要指标

Outcome：

Utilization of follow-up service in hypertensive patients

Type：

Secondary indicator

测量时间点：

测量方法：

问卷调查法

Measure time point of outcome：

Measure method：

Questionaire survey

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

无

组织：

Sample Name：

N/A

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 18 岁 years
最大 Max age 99 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）：

有研究者使用计算机辅助随机分组。本研究采用 SMART 设计，通过两阶段随机分组，开展随机对照试验，全面评估自适应干预模式的动态干预效果。在第一阶段，将高血压患者随机分配至标准互动组和强化互动组，开展为期 6 个月的干预。在第二阶段，通过评估高血压患者自我管理行为的变化，动态调整医患互动干预类型，进行第二次随机分组，开展第二阶段干预。通过以上两阶段随机分组，划分不同干预类型组合，全面评估其动态干预效果，以筛选改善高血压患者自我管理行为的最优干预类型组合，建立促进农村高血压患者自我管理行为的可持续性干预模式。

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

Computer-assisted randomised grouping was used by the researcher. In this study, a SMART design was used to conduct a randomised controlled trial to comprehensively assess the dynamic intervention effects of the adaptive intervention model through a two-phase randomised grouping. In the first phase, hypertensive patients were randomly assigned to the standard and intensive interaction groups for a 6-month intervention. In the second phase, the type of doctor-patient interaction was dynamically adjusted by assessing the changes in the self-management behaviour of hypertensive patients, and a second randomised group was formed to carry out the second phase of the intervention. Through the above two phases of randomisation, different combinations of intervention types were classified, and their dynamic intervention effects were comprehensively assessed, in order to select the optimal combination of intervention types to improve the self-management behaviour of hypertensive patients, and to establish a sustainable intervention model to promote the self-management behaviour of hypertensive patients in rural areas.

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：

无

Blinding：

None

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：

由经过统一培训的调查员，采用面对面访谈的方式对样本村的高血压患者或高血压随访管理医生开展调查，主要收集高血压患者的固定特征、动态特征、医患互动以及高血压患者自我管理行为的相关信息以及收集基层医生的固定特征和动态特征信息。 管理：经三查三核对无误后上传数据库云服务器（世界银行开发的 Survey Solution 系统搭载的线上云服务器）

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

Collection: A uniformly trained surveyor conducts a survey using face-to-face interviews with hypertension patients or hypertension follow-up management doctors in the sample villages, mainly collecting information on fixed characteristics, dynamic characteristics, doctor-patient interactions, and self-management behaviours of hypertension patients, as well as collecting information on the fixed and dynamic characteristics of primary care doctors. Management: Uploaded to the database cloud server (the online cloud server hosted by the Survey Solution System developed by the World Bank) after the three checks and three verifications are correct.

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：

  2024-08-06 14:44:32