Construction and Verification of Adaptive Intervention Model for Self-Management Behavior of Hypertensive Patients in Rural Areas：A Perspective of Doctor-Patient Interactions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 1
- 主要终点
- Blood pressure
研究概览
简要总结
The aim of this project is to develop and validate an adaptive intervention model to improve self-management behavior in rural hypertensive patients. The primary question it seeks to answer is: Can a tailored, interaction-based intervention model, guided by key doctor-patient interaction elements, effectively enhance self-management behavior among rural hypertensive patients and improve long-term blood pressure control? Researchers will evaluate the impact of different intervention strategies on self-management behavior and identify the most effective combination to establish a sustainable intervention model for rural hypertension management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed hypertension patients who are permanent residents in rural areas.
- •No plans for long-term relocation within the next year.
- •Willing to participate in this study.
- •No cognitive impairment.
- •No other diseases that significantly affect self-management behavior, such as malignant tumors.
排除标准
- •Age over 80 years.
- •Having conditions such as stroke, paralysis, or mental disorders that prevent the completion of self-management behaviors.
- •Severe hearing impairment or speech disorders that prevent participation in interviews.
- •Likely to relocate or be away from the local area for an extended period within one year.
研究组 & 干预措施
Standard Interactive Intervention with Continued Standard Intervention for Poor Self-Management
This study consists of two stage. In the first stage, participants are randomly assigned to the standard interactive intervention group. After six months, those with poor self-management behavior are randomly assigned to either continue the standard interactive intervention or switch to the enhanced interactive intervention in the second stage. This arm consists of participants who were initially assigned to the standard interactive intervention for six months and were subsequently reassigned to continue the standard interactive intervention in the second stage.
The intervention content is designed based on the Health Behavior Interaction Model, covering four aspects: health information (e.g., potential risks of poor self-management behavior), professional skills (e.g., blood pressure measurement), emotional support (e.g., understanding the experiences of hypertension patients), and decision-making participation. Conducted once a month.
干预措施: Standard Interactive Intervention for Hypertension Management (Behavioral)
Standard Interactive Intervention Followed by Enhanced Intervention for Poor Self-Management
In the first stage, participants are randomly assigned to the standard interactive intervention group. After six months, those with poor self-management behavior are randomly assigned to either continue the standard interactive intervention or switch to the enhanced interactive intervention in the second stage. This arm consists of participants who were initially assigned to the standard interactive intervention for six months and were subsequently reassigned to the enhanced interactive intervention in the second stage.
The enhanced interactive intervention refers to the same intervention as the standard interactive group, with an increased frequency of interactions. Every two weeks, a brief interactive intervention is conducted via the intelligent outbound call system to remind patients to perform their self-management behaviors.
干预措施: Standard Interactive Intervention for Hypertension Management (Behavioral)
Standard Interactive Intervention Followed by Regular Follow-Up Management
First phase: Randomly assigned to the standard interactive intervention group (6 months). Second phase: Participants with improved self-management behavior are transitioned to regular follow-up management (6 months).
干预措施: Standard Interactive Intervention for Hypertension Management (Behavioral)
Intensified Interactive Intervention Followed by Standard Interactive Intervention
In the first stage, participants are randomly assigned to the intensified interactive intervention group. After six months, those with improved self-management behavior are randomly assigned to either continue with the standard interactive intervention or transition to routine follow-up management. This arm consists of participants who were initially assigned to the intensified interactive intervention for six months and were subsequently reassigned to the standard interactive intervention in the second stage.
干预措施: Intensified Interactive Intervention for Hypertension Management (Behavioral)
Intensified Interactive Intervention Followed by Routine Follow-Up
In the first stage, participants are randomly assigned to the intensified interactive intervention group. After six months, those with improved self-management behavior are randomly assigned to either continue with the standard interactive intervention or transition to routine follow-up management. This arm consists of participants who were initially assigned to the intensified interactive intervention for six months and were subsequently reassigned to the routine follow-up management in the second stage.
干预措施: Intensified Interactive Intervention for Hypertension Management (Behavioral)
Intensified Interactive Intervention with Continued Intensification
In the first stage, participants are randomly assigned to the intensified interactive intervention group for six months. In the second stage, those with poor self-management behavior at the end of the first stage will continue receiving the intensified interactive intervention for another six months.
干预措施: Intensified Interactive Intervention for Hypertension Management (Behavioral)
结局指标
主要结局
Blood pressure
时间窗: From the start of the intervention to the 6-month and the end of the trial at 12 months.
Hypertension self-management behavior
时间窗: From the start of the intervention to the 6-month and the end of the trial at 12 months.
Hypertension self-management behavior includes six dimensions: medication management, condition monitoring, dietary management, exercise management, work and rest management, and emotional management. Each item is scored on a 1 to 5 scale, with a total score ranging from 33 to 165. A higher total score indicates a higher level of self-management in patients.
次要结局
未报告次要终点
研究者
Yuju Wu
Associate Professor
Sichuan University