Antimicrobial Drug ResistanceNCT06967766
A Complex Intervention to Promote Appropriate Antibiotic Use Among Rural Residents Based on the Metaphor-Embedded Integrated Behavioral Model
A study testing health education based on the Metaphor-Embedded Integrated Behavioral Model in people with Antimicrobial Drug Resistance, run by Bo Yan.
Trial summary
The study aims to address the question of how to provide effective health education on health topics with high medical specialisation (e.g. bacterial drug resistance in this study), especially for rural or low-educated populations. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Antimicrobial Drug Resistance
- What is being tested?
- health education based on the Metaphor-Embedded Integrated Behavioral Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,500 participants
- Where
- No sites listed yet
- Study dates
- May 2025to Jun 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Residents aged 18 years and over who have lived in the survey township for more than 6 months
Who cannot join
- Residents with mental illness, severe mental health problems, and those unable to complete the questionnaire
About this study
The study aims to address the question of how to provide effective health education on health topics with high medical specialisation (e.g. bacterial drug resistance in this study), especially for rural or low-educated populations. In response to the high degree of correlation between irrational antimicrobial drug use behaviours, how to achieve the effectiveness of interventions on the complex health topic of rational use of antimicrobial drugs through synergistic interventions with multiple scenarios?
In this study, the investigators used an experimental-like research design to conduct a full-scenario intervention involving antimicrobial drug acquisition, use, and disposal in a township-based approach, so as to reduce the prevalence of irrational antimicrobial drug use behaviours among rural residents, and to significantly improve the governance of antimicrobial drug use in rural areas. After six months of intervention, the following specific objectives were achieved:
Read more
- The incidence of self-treatment and use of antimicrobial drugs in the intervention group decreased by 30% compared with the control group;
- Rational use of antimicrobial drugs and awareness of bacterial drug resistance among rural residents in the intervention group increased by 50% compared with the control group;
- In the intervention group, the incidence of rural residents actively asking for antimicrobial drugs when seeking medical treatment, actively purchasing antimicrobial drugs without prescription at community pharmacies, stocking up on antimicrobial drugs at home, and improperly disposing of antimicrobial drugs decreased by 40%, 30%, 30%, and 50%, respectively, compared with that of the control group.
The study included the development and testing of metaphorical health materials and a multi-contextual metaphorical health education intervention. The implementation of the intervention included training in metaphorical health education and doctor-patient communication, a multi-situational intervention based on the theory of metaphorically embedded integrative behaviours, and the design of incentives for standardised antimicrobial drug discarding.
- Conditions
- Antimicrobial Drug Resistance
- Being tested
- health education based on the Metaphor-Embedded Integrated Behavioral Model
- Keywords
- health education, Metaphor
- Medical subject headings
- Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
health education based on the Metaphor-Embedded Integrated Behavioral ModelBehavioural
In each intervention scenario, health education information is set to target key behaviors in the scenario. In the main scenarios for obtaining antibiotics, such as township health centers, village clinics, and community pharmacies, scenario-driven interventions are carried out for two key behaviors: patients actively asking for antibiotics (led by doctors in township health centers) and customers buying antibiotics without prescriptions (led by community pharmacy staff).
| Study group | Role | What they receive |
|---|---|---|
| Metaphor-based health education | Experimental | In each intervention scenario, health education information is set to target key behaviors in the scenario. In the main scenarios for obtaining antibiotics, such as township health centers, village clinics, and community pharmacies, scenario-driven interventions are carried out for two key behaviors: patients actively asking for antibiotics (led by doctors in township health centers) and customers buying antibiotics without prescriptions (led by community pharmacy staff). Receives: Behavioral: health education based on the Metaphor-Embedded Integrated Behavioral Model |
| Regular education | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
antibiotic use
Changes in antibiotic use rates among sick rural residents in the past month(self-treatment with antibiotics and antibiotics prescribed by doctors when seeking medical treatment)
Measured: six months
Secondary outcomes (5)
knowledge
Rational use of antibiotics and awareness of bacterial resistance among rural residents
Measured: six months
Prevalence of unsolicited requests for antimicrobial drugs at medical appointments
Question：Did you voluntarily ask your doctor for antibiotics during your visit? The options contain yes and no.
Measured: six months
Prevalence of unsolicited purchase of antimicrobials without a prescription at a pharmacy
Question：In the past month, have you gone to the pharmacy and voluntarily purchased antibiotics without a doctor's prescription? Options include yes and no.
Measured: six months
Proportion of residents stocking antimicrobial drugs at home
Do you currently keep antibiotics in your home? (Do not include antibiotics that have been prescribed for you or a family member by your doctor and that you are currently taking) The options include yes, no and unknown.
Measured: six months
Incidence of unregulated disposal of antimicrobial drugs
Questions：
- Have you disposed of antibiotics that you no longer use in your home?
- If yes, how did you handle it the last 1 time? The options include ①Throw it into the rubbish bin ②Pour it into a flush toilet or sink and flush it away ③Give it to someone else ④Send it to a pharmacy/medical institution, etc. for recycling ⑤Recycle it through electronic platforms such as Alipay ⑥ Give it to a professional for disposal ⑦ Other (please specify)
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study startMay 2025 (estimated)
- Primary completionNov 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial Drug ResistanceStudies 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bo Yan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bo Yan, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967766
- Sponsor's protocol ID
- ZGL202504-10
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Complex Intervention to Promote Appropriate Antibiotic Use Among Rural Residents Based on the Metaphor-Embedded Integrated Behavioral Model
- ClinicalTrials.gov ID
- NCT06967766
- Acronym / sponsor ID
- ZGL202504-10
- Conditions
- Antimicrobial Drug Resistance
- Keywords
- health education, Metaphor
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- Bo YanUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 May 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 study aims to address the question of how to provide effective health education on health topics with high medical specialisation (e.g. bacterial drug resistance in this study), especially for rural or low-educated populations. In response to the high degree of correlation between irrational antimicrobial drug use behaviours, how to achieve the effectiveness of interventions on the complex health topic of rational use of antimicrobial drugs through synergistic interventions with multiple scenarios?
In this study, the investigators used an experimental-like research design to conduct a full-scenario intervention involving antimicrobial drug acquisition, use, and disposal in a township-based approach, so as to reduce the prevalence of irrational antimicrobial drug use behaviours among rural residents, and to significantly improve the governance of antimicrobial drug use in rural areas. After six months of intervention, the following specific objectives were achieved:
- The incidence of self-treatment and use of antimicrobial drugs in the intervention group decreased by 30% compared with the control group;
- Rational use of antimicrobial drugs and awareness of bacterial drug resistance among rural residents in the intervention group increased by 50% compared with the control group;
- In the intervention group, the incidence of rural residents actively asking for antimicrobial drugs when seeking medical treatment, actively purchasing antimicrobial drugs without prescription at community pharmacies, stocking up on antimicrobial drugs at home, and improperly disposing of antimicrobial drugs decreased by 40%, 30%, 30%, and 50%, respectively, compared with that of the control group.
The study included the development and testing of metaphorical health materials and a multi-contextual metaphorical health education intervention. The implementation of the intervention included training in metaphorical health education and doctor-patient communication, a multi-situational intervention based on the theory of metaphorically embedded integrative behaviours, and the design of incentives for standardised antimicrobial drug discarding.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metaphor-based health education | Experimental | Behavioral: health education based on the Metaphor-Embedded Integrated Behavioral ModelIn each intervention scenario, health education information is set to target key behaviors in the scenario. In the main scenarios for obtaining antibiotics, such as township health centers, village clinics, and community pharmacies, scenario-driven interventions are carried out for two key behaviors: patients actively asking for antibiotics (led by doctors in township health centers) and customers buying antibiotics without prescriptions (led by community pharmacy staff). |
| Regular education | No intervention | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Residents aged 18 years and over who have lived in the survey township for more than 6 months
Key exclusion criteria (1 listed)
- Residents with mental illness, severe mental health problems, and those unable to complete the questionnaire
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 |
|---|---|---|
| health education based on the Metaphor-Embedded Integrated Behavioral ModelIn each intervention scenario, health education information is set to target key behaviors in the scenario. In the main scenarios for obtaining antibiotics, such as township health centers, village clinics, and community pharmacies, scenario-driven interventions are carried out for two key behaviors: patients actively asking for antibiotics (led by doctors in township health centers) and customers buying antibiotics without prescriptions (led by community pharmacy staff). | Behavioural | Metaphor-based health education |
Primary outcome
antibiotic use
Time frame: six months
Changes in antibiotic use rates among sick rural residents in the past month(self-treatment with antibiotics and antibiotics prescribed by doctors when seeking medical treatment)
5 secondary outcomes
knowledge
Time frame: six months
Prevalence of unsolicited requests for antimicrobial drugs at medical appointments
Time frame: six months
Prevalence of unsolicited purchase of antimicrobials without a prescription at a pharmacy
Time frame: six months
Proportion of residents stocking antimicrobial drugs at home
Time frame: six months
Incidence of unregulated disposal of antimicrobial drugs
Time frame: six 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 13 May 2025.
Related trials for Antimicrobial Drug Resistance
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruitingPhase 2
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
Multi-Drug Resistant Organism Colonization
Not yet recruiting
Farm-originated Antimicrobial Resistance Modeling: Exploring Humans-to-Animal Dissemination
Methicillin-Resistant Staphylococcus Aureus Colonization
Recruiting
INterest of the Negative Predictive Value of Integrons in the reduCtion of Large Broad-spectrum anTibiotics Consumption for Urinary Tract infectionS
Drug Resistance, Microbial, Biomarkers
Not yet recruitingObservational study
Traditional Chinese Medicine in Multidrug-Resistant Bacterial Pneumonia
Multi Drug Resistant Infections, Pneumnia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing health education based on the Metaphor-Embedded Integrated Behavioral Model in people with Antimicrobial Drug Resistance, run by Bo Yan.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
antibiotic use (time frame: six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2025.