Adaptive Intervention Model for Hypertension Self-Management in Rural Areas: A Doctor-Patient Interaction Approach

NCT ID: NCT06869031

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-01
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Hypertension Self-management; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Standard Interactive Intervention for Hypertension Management

Intervention Type: BEHAVIORAL

The standard interactive intervention is a doctor-patient interaction intervention conducted by follow-up physicians using an intelligent outbound call system as part of follow-up management. It is implemented once a month and is designed based on the Health Behavior Interaction Model, covering four key aspects: health information (e.g., potential risks of poor self-management behavior), professional skills(e.g., blood pressure measurement, medication guidance), emotional support , and decision-making participation.

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.

Group Type: EXPERIMENTAL

Standard Interactive Intervention for Hypertension Management

Intervention Type: BEHAVIORAL

The standard interactive intervention is a doctor-patient interaction intervention conducted by follow-up physicians using an intelligent outbound call system as part of follow-up management. It is implemented once a month and is designed based on the Health Behavior Interaction Model, covering four key aspects: health information (e.g., potential risks of poor self-management behavior), professional skills(e.g., blood pressure measurement, medication guidance), emotional support , and decision-making participation.

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).

Group Type: EXPERIMENTAL

Standard Interactive Intervention for Hypertension Management

Intervention Type: BEHAVIORAL

The standard interactive intervention is a doctor-patient interaction intervention conducted by follow-up physicians using an intelligent outbound call system as part of follow-up management. It is implemented once a month and is designed based on the Health Behavior Interaction Model, covering four key aspects: health information (e.g., potential risks of poor self-management behavior), professional skills(e.g., blood pressure measurement, medication guidance), emotional support , and decision-making participation.

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.

Group Type: EXPERIMENTAL

Intensified Interactive Intervention for Hypertension Management

Intervention Type: BEHAVIORAL

The enhanced interactive intervention builds upon the standard interactive intervention by increasing the frequency of interactions. In addition to the monthly intervention, patients receive an additional brief interactive intervention every two weeks via the intelligent outbound call system, reminding them to adhere to self-management behaviors for hypertension control.

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.

Group Type: EXPERIMENTAL

Intensified Interactive Intervention for Hypertension Management

Intervention Type: BEHAVIORAL

The enhanced interactive intervention builds upon the standard interactive intervention by increasing the frequency of interactions. In addition to the monthly intervention, patients receive an additional brief interactive intervention every two weeks via the intelligent outbound call system, reminding them to adhere to self-management behaviors for hypertension control.

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.

Group Type: EXPERIMENTAL

Intensified Interactive Intervention for Hypertension Management

Intervention Type: BEHAVIORAL

The enhanced interactive intervention builds upon the standard interactive intervention by increasing the frequency of interactions. In addition to the monthly intervention, patients receive an additional brief interactive intervention every two weeks via the intelligent outbound call system, reminding them to adhere to self-management behaviors for hypertension control.

Interventions

Standard Interactive Intervention for Hypertension Management

The standard interactive intervention is a doctor-patient interaction intervention conducted by follow-up physicians using an intelligent outbound call system as part of follow-up management. It is implemented once a month and is designed based on the Health Behavior Interaction Model, covering four key aspects: health information (e.g., potential risks of poor self-management behavior), professional skills(e.g., blood pressure measurement, medication guidance), emotional support , and decision-making participation.

Intervention Type: BEHAVIORAL

Intensified Interactive Intervention for Hypertension Management

The enhanced interactive intervention builds upon the standard interactive intervention by increasing the frequency of interactions. In addition to the monthly intervention, patients receive an additional brief interactive intervention every two weeks via the intelligent outbound call system, reminding them to adhere to self-management behaviors for hypertension control.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuju Wu

OTHER

Sponsor Role: lead

Responsible Party

Yuju Wu

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

West China Fourth Hospital and West China School of Public Health. Sichuan University

Chengdu, Sichuan, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuju Wu

Role: CONTACT

yujuwu@scu.edu.cn

86+18382096899

Facility Contacts

Yuju Wu

Role: primary

yujuwu@scu.edu.cn

86+18382096899

Other Identifiers

Gwll2024130

Identifier Type: -

Identifier Source: org_study_id