Evaluation of an easy and pragmatic intervention to reduce antibiotic use for symptomatic respiratory infections in China
| ISRCTN | ISRCTN29801086 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29801086 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | National Natural Science Foundation of China |
| Funder | National Natural Science Foundation of China |
- Submission date
- 18/09/2022
- Registration date
- 23/09/2022
- Last edited
- 05/10/2023
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Antibiotics are over-used for patients with respiratory-tract infections (RTIs, coughs & colds) in primary care, especially in the rural areas of China. This study proposes a tailored message package for educating patients with symptomatic RTIs to reduce antibiotic use. The study aims to assess the message package's efficacy through a randomized controlled trial (RCT).
Who can participate?
30 township health centres from 2 cities across Anhui Province, China will be selected as study sites. All the patients with RTIs who present to the 30 clinics during the study period will be invited to participate in the study.
What does the study involve?
The control arm maintains usual care; while eligible patients in the intervention arm, will be sent 12 tailored massages in 12 consecutive days (once a day).
For any recruited patient, the baseline interview happens within 1-2 days of his/her visit to the health center; while the follow-up interviews are scheduled at 7, 14, 21,180 and 365 days after the baseline.
What are the possible benefits and risks of participating?
There are no major risks from taking part in the study. However, the baseline and follow up interviews will take 8 to 15 minutes each time. Possible benefit could be that participants will learn the harm of antibiotics and what to do after re-infection.
Where is the study run from?
Anhui Medical University (China)
When is the study starting and how long is it expected to run for?
February 2022 to July 2027
Who is funding the study?
National Natural Science Foundation of China (China)
Who is the main contact?
Miss Rong Liu
liurongang123@163.com
Contact information
Scientific
Anhui Medical University
81 Meishan Road
Hefei
230032
China
 ORCID ID |
0000-0002-7968-5932 |
|---|---|
| Phone | +86 551-65116395 |
| liurong@ahmu.edu.cn |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multi-centre cluster randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Evaluation of a tailored message package for educating patients to reduce antibiotics use for symptomatic respiratory-tract infections |
| Study objectives | The tailored message package for educating patients intervention will reduce unnecessary antibiotic uses for patients with symptomatic respiratory-tract infections (RTI) in township health centres in rural China. |
| Ethics approval(s) | Approved 01/03/2022, Anhui Medical University Biomedical Ethics Committee (Anhui Medical University, 81 Meishan Road, Hefei, Anhui, China; +86 0551-65161053; renzhenhua@ahmu.edu.cn), ref: 81220189 |
| Health condition(s) or problem(s) studied | Symptomatic respiratory tract infectious |
| Intervention | A total of 30 township/community health centers within 2 cities, Anhui Province, China will be recruited. All the township/community health centers will be randomised at a 1:1 ratio to the control arm or the intervention arm. Each arm will have 15 township/community health centers. The control arm maintains usual care; while eligible patients in the intervention arm, will be sent 12 tailored massages in 12 consecutive days (once a day). Project evaluation applies to all arms using the same data collection methods and by the same field data collectors. A novel computerized program has been developed for tailoring the messages to the need and context of individual patients. Each of the messages is designed as a template inserted with substitution variables which are replaced with relevant values and/or text according to the actual conditions and contexts of the patient under concern. The whole process of the message design, modification, translation (of substitution variables) and sending is facilitated by the user-friendly mini computer program. |
| Intervention type | Behavioural |
| Primary outcome measure(s) | Number of days in which antibiotics are used by patients with symptomatic RTIs measured using telephone questionnaire at initial consultation, 7 and 14 days |
| Key secondary outcome measure(s) | 1. Patients’ knowledge about and attitude toward antibiotics measured using telephone questionnaire at 180 and 365 days 2. Patients’ quality of life measured using EQ-5D at initial consultation 7, 180 and 365 days 3. Patients' symptom severity and duration measured using telephone questionnaire at initial consultation, 7, 14 and 21 days 4. Times of re-visits to clinics and antibiotics re-prescription for the same RTI episode measured using telephone questionnaire at 14 and 21 days 5. Times of re-occurrence of RTIs within six or twelve months after the intervention and related health service seeking and antibiotics consumption measured using telephone questionnaire at 180 and 365 days |
| Completion date | 30/12/2027 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 833 |
| Key inclusion criteria | 1. 18 years or older and able to give consent to participate in the patient survey and/or follow-up interviews 2. Diagnosed with an RTIs in the recruitment consultation: blocked/runny nose, coughing with or without sputum, dry/sore throat, breathing problems, fever, ear inflammation (blocked ear, tinnitus, ear discharges, earache) 3. Able to read messages 4. Have a mobile phone that can receive messages |
| Key exclusion criteria | 1. Have previously sought treatment for this illness from a normal clinic 2. Unable to provide fully informed consent (e.g. due to dementia, psychosis, or severe depression) 3. Can't receive messages 4. Unable to read messages |
| Date of first enrolment | 01/12/2023 |
| Date of final enrolment | 30/12/2026 |
Locations
Countries of recruitment
- China
Study participating centre
Hefei
230032
China
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | 04/10/2023 | 05/10/2023 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | 21/09/2022 | No | No |
Additional files
Editorial Notes
05/10/2023: Publication reference added.
03/02/2023: The recruitment end date was changed from 01/08/2022 to 01/12/2023.
21/09/2022: Trial's existence confirmed by Anhui Medical University Biomedical Ethics Committee.
