Hypertension Self-managementNCT06869031
Adaptive Intervention Model for Hypertension Self-Management in Rural Areas: A Doctor-Patient Interaction Approach
A study testing Standard Interactive Intervention for Hypertension Management and Intensified Interactive Intervention for Hypertension Management in people with Hypertension Self-management and Hypertension, run by Yuju Wu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypertension Self-management, Hypertension
- What is being tested?
- Standard Interactive Intervention for Hypertension Management and Intensified Interactive Intervention for Hypertension Management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
West China Fourth Hospital and West China School of Public Health. Sichuan University
Chengdu, Sichuan
Yuju Wu, 86+18382096899, yujuwu@scu.edu.cn
About this study
Official title: Construction and Verification of Adaptive Intervention Model for Self-Management Behavior of Hypertensive Patients in Rural Areas：A Perspective of Doctor-Patient Interactions
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
- Being tested
- Standard Interactive Intervention for Hypertension Management, Intensified Interactive Intervention for Hypertension Management
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Interactive Intervention for Hypertension ManagementBehavioural
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 for Hypertension ManagementBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Interactive Intervention with Continued Standard Intervention for Poor Self-Management | Experimental | 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. Receives: Behavioral: Standard Interactive Intervention for Hypertension Management |
| Standard Interactive Intervention Followed by Enhanced Intervention for Poor Self-Management | Experimental | 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. Receives: Behavioral: Standard Interactive Intervention for Hypertension Management |
| Standard Interactive Intervention Followed by Regular Follow-Up Management | Experimental | 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). Receives: Behavioral: Standard Interactive Intervention for Hypertension Management |
| Intensified Interactive Intervention Followed by Standard Interactive Intervention | Experimental | 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. Receives: Behavioral: Intensified Interactive Intervention for Hypertension Management |
| Intensified Interactive Intervention Followed by Routine Follow-Up | Experimental | 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. Receives: Behavioral: Intensified Interactive Intervention for Hypertension Management |
| Intensified Interactive Intervention with Continued Intensification | Experimental | 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. Receives: Behavioral: Intensified Interactive Intervention for Hypertension Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypertension self-management behavior
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.
Measured: From the start of the intervention to the 6-month and the end of the trial at 12 months.
Blood pressure
Measured: From the start of the intervention to the 6-month and the end of the trial at 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Jun 2025
- Primary completion15 Jun 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension Self-managementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yuju Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yuju Wu, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869031
- Sponsor's protocol ID
- Gwll2024130
- Status last verified
- Aug 2025
- First submitted
- 19 Feb 2025
- Last updated
- 20 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xian X, Zhao T, Du S, Zhang H, Chen Y, Zhou H, Wu Y. Adaptive intervention to improve self-management behaviours among hypertensive patients in rural primary care settings: protocol for a Sequential Multiple Assignment Randomised Trial (SMART). BMJ Open. 2026 Mar 18;16(3):e109445. doi: 10.1136/bmjopen-2025-109445.
PubMed 41857823
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Verification of Adaptive Intervention Model for Self-Management Behavior of Hypertensive Patients in Rural Areas：A Perspective of Doctor-Patient Interactions
- ClinicalTrials.gov ID
- NCT06869031
- Acronym / sponsor ID
- Gwll2024130
- Conditions
- Hypertension Self-management, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Yuju WuUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Standard Interactive Intervention with Continued Standard Intervention for Poor Self-Management | Experimental | Behavioral: Standard Interactive Intervention for Hypertension ManagementThis 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. |
| Standard Interactive Intervention Followed by Enhanced Intervention for Poor Self-Management | Experimental | Behavioral: Standard Interactive Intervention for Hypertension ManagementIn 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. |
| Standard Interactive Intervention Followed by Regular Follow-Up Management | Experimental | Behavioral: Standard Interactive Intervention for Hypertension ManagementFirst 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). |
| Intensified Interactive Intervention Followed by Standard Interactive Intervention | Experimental | Behavioral: Intensified Interactive Intervention for Hypertension ManagementIn 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. |
| Intensified Interactive Intervention Followed by Routine Follow-Up | Experimental | Behavioral: Intensified Interactive Intervention for Hypertension ManagementIn 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. |
| Intensified Interactive Intervention with Continued Intensification | Experimental | Behavioral: Intensified Interactive Intervention for Hypertension ManagementIn 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Interactive Intervention for Hypertension ManagementThe 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. | Behavioural | Standard Interactive Intervention Followed by Enhanced Intervention for Poor Self-Management, Standard Interactive Intervention Followed by Regular Follow-Up Management, Standard Interactive Intervention with Continued Standard Intervention for Poor Self-Management |
| Intensified Interactive Intervention for Hypertension ManagementThe 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. | Behavioural | Intensified Interactive Intervention Followed by Routine Follow-Up, Intensified Interactive Intervention Followed by Standard Interactive Intervention, Intensified Interactive Intervention with Continued Intensification |
Primary outcome
Hypertension self-management behavior
Time frame: 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.
Blood pressure
Time frame: From the start of the intervention to the 6-month and the end of the trial at 12 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2025.
- Derived from this study: PubMed 41857823Xian X, Zhao T, Du S, Zhang H, Chen Y, Zhou H, Wu Y. Adaptive intervention to improve self-management behaviours among hypertensive patients in rural primary care settings: protocol for a Sequential Multiple Assignment Randomised Trial (SMART). BMJ Open. 2026 Mar 18;16(3):e109445. doi: 10.1136/bmjopen-2025-109445.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Interactive Intervention for Hypertension Management and Intensified Interactive Intervention for Hypertension Management in people with Hypertension Self-management and Hypertension, run by Yuju Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuju Wu (86+18382096899, yujuwu@scu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypertension self-management behavior (time frame: From the start of the intervention to the 6-month and the end of the trial at 12 months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06869031, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2025.