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

Yuju Wu

Status: Enrolling

Conditions: Hypertension; Hypertension Self-management

Treatments: Behavioral: Standard Interactive Intervention for Hypertension Management; Behavioral: Intensified Interactive Intervention for Hypertension Management

Study type: Interventional

Funder types: Other

Identifiers

NCT06869031

Gwll2024130

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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320 participants in 6 patient groups

Standard Interactive Intervention with Continued Standard Intervention for Poor Self-Management

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Interactive Intervention for Hypertension Management

Standard Interactive Intervention Followed by Enhanced Intervention for Poor Self-Management

Experimental group

Description:

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.

Treatment:

Behavioral: Standard Interactive Intervention for Hypertension Management

Standard Interactive Intervention Followed by Regular Follow-Up Management

Experimental group

Description:

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).

Treatment:

Behavioral: Standard Interactive Intervention for Hypertension Management

Intensified Interactive Intervention Followed by Standard Interactive Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Intensified Interactive Intervention for Hypertension Management

Intensified Interactive Intervention Followed by Routine Follow-Up

Experimental group

Description:

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.

Treatment:

Behavioral: Intensified Interactive Intervention for Hypertension Management

Intensified Interactive Intervention with Continued Intensification

Experimental group

Description:

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.

Treatment:

Behavioral: Intensified Interactive Intervention for Hypertension Management