Helicobacter Pylori InfectionHpNCT06749873
Assessing Hp Diagnosis and Treatment Quality of direct-to Consumer Telemedicine in Mainland China
An observational study of Helicobacter Pylori Infection, run by Shandong University at 1 site in China.
Trial summary
A quality assessment of the level of H. pylori diagnosis and treatment in mainland China's Direct-to-consumer telemedicine (DTCT) was conducted by means of Unannounced standardized patients (USPs). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Helicobacter Pylori Infection
- What is being tested?
- Background of different SP information
- How many people
- 552 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2024to 31 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 60 years
- All sexes
- No healthy volunteers
- Adult
Study population: Undeclared Standardized patient (USP) usually refers to a teaching tool used in medical education and training. These standardized patients are trained actors who simulate the conditions, symptoms, and emotional responses of real patients to help physicians improve their clinical skills. In the "undeclared" scenario, these standardized patients may not reveal their identity at the outset, but participate in training or evaluation as real patients, allowing medicine to diagnose and treat without prior preparation. This approach can more realistically simulate the clinical environment and help improve clinical thinking skills, communication skills and understanding of patients. It is expected that 10 research assistants will be included for USP training.
Who may be able to join
- An Internet hospital dominated by physical hospitals in the seven geographical regions of gastroenterology specialty reputation shortlisted by the Hospital Research Institute of Fudan University in China
- Be included in the top 20 enterprise-led Internet medical consulting platforms based on popularity and user recognition
Who cannot join
- Physical hospitals without Internet hospitals
- The entity hospital of the Internet hospital can only be revisited
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing Helicobacter Pylori Diagnosis and Treatment Quality of direct-to Consumer Telemedicine in Mainland China: a Cross-sectional Study Using Unannounced Standardised Patients
A quality assessment of the level of H. pylori diagnosis and treatment in mainland China's Direct-to-consumer telemedicine (DTCT) was conducted by means of Unannounced standardized patients (USPs).
Read the detailed description
Direct-to-consumer telemedicine (DTCT) refers to a model in which doctors provide medical advice and services directly to patients through the Internet and communication technologies. Under the background of globalization and information age, DTCT, as an innovative medical service model, is gradually changing the traditional face of the medical industry. Especially in today's highly developed information and network, telemedicine service has become an important way to improve the accessibility of medical services, reduce medical costs, and optimize the allocation of medical resources. In China, with the in-depth implementation of the Healthy China strategy, DTCT is regarded as a key link to deepen medical reform and build a new medical service system. In 2018, the Chinese government began to introduce a series of DTCT policy measures to promote the development of telemedicine. By June 2022, China has approved and set up more than 1,700 Internet hospitals, initially forming an integrated online and offline medical services2. As of February 2024, China's National Health Commission has approved the establishment of more than 2,700 Internet hospitals across the country. In addition to the Internet hospitals dominated by physical hospitals, the enterprise-led Internet medical consulting platform has also gradually flourished and gradually occupied a large market share.
The speed of development of DTCT is encouraging, but the quality of care in DTCT is more uncertain. In 2024, a Chinese study published was the first to evaluate multi-disease online diagnosis and treatment services offered on Chinese Internet diagnosis and treatment platforms, using anonymous standardized patients. The study found that the current quality of Internet diagnosis and treatment services is not ideal: out of 170 anonymous consultations, the access success rate is only 63.5% (108/170); Of the visits successfully completed, only 49 consultations (45%) resulted in a correct diagnosis. In terms of physician adherence to the guidelines, the rate of completion of consultation and disposal was 15% and 31%, respectively.
Helicobacter pylori (Hp) infection is a common gastrointestinal disease, which is closely related to the occurrence of gastritis, peptic ulcer, gastric cancer and other diseases. Globally, 43.1% of the population is infected with Helicobacter pylori. In China, the infection rate is also close to 50%. Hp infection has a huge demand for treatment, and it also faces many problems such as complicated treatment plan. Direct-to-consumer telemedicine services offer new possibilities for the treatment of Hp infection, greatly facilitating patients, especially those in remote areas and primary care facilities. However, there is uncertainty in the quality of H. pylori treatment in telemedicine services.
- Conditions
- Helicobacter Pylori Infection
- Being tested
- Background of different SP information
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Background of different SP informationOther
Sp was asked with the following baseline information: 1. 50 years of age and gender; 2. positive urea breath test; 3. asymptomatic; 4. family history of gastric cancer; 5. gastroscopy: atrophic gastritis; 6. untreated; and 7. no history of drug allergies.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Sp was asked with the following baseline information: 1. 20 years of age and gender; 2. positive urea breath test; 3. no symptoms; 4. no family history of gastric cancer; 5. gastroscopy: non-atrophic gastritis; 6. no treatments; and 7. no history of drug allergies. Receives: Other: Background of different SP information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Guidelines compliance
For the doctor's inquiry through SP, the doctor's answer will be scored against the current guidelines, and the correct answer according to the guidelines will get the corresponding score, out of 10 points. Adherence to the physician's guidelines will be judged by the high or low scores assessed.
Measured: 3 months
Patient satisfaction
Through the SP for the doctor's inquiry, the doctor's attitude will be scored, and the corresponding score will be obtained. The patient's satisfaction with the physician will be judged by the high or low score of the assessment
Measured: 3 months
Secondary outcomes (1)
Response rate
Ratio of physician responses to consultations in Internet hospitals
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Dec 2024
- Primary completion31 Jan 2025
- Study completion31 Jan 2025
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 Helicobacter Pylori InfectionStudies 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
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 552 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiuli Zuo, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749873
- Sponsor's protocol ID
- QLYY-2024-001
- Other IDs
- 82270570
- Acronym
- Hp
- Status last verified
- Feb 2025
- First submitted
- 30 Nov 2024
- Last updated
- 19 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Duan M, Ju KP, Yang XY, Li YQ, Li YY, Kong QZ, Zuo XL. Quality of Helicobacter pylori Infection Management Through Telemedicine: A Nationwide Cross-Sectional Study. J Dig Dis. 2026 Jul 16. doi: 10.1111/1751-2980.70061. Online ahead of print.
PubMed 42464062
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing Helicobacter Pylori Diagnosis and Treatment Quality of direct-to Consumer Telemedicine in Mainland China: a Cross-sectional Study Using Unannounced Standardised Patients
- ClinicalTrials.gov ID
- NCT06749873
- Acronym / sponsor ID
- Hp / QLYY-2024-001
- Conditions
- Helicobacter Pylori Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 552 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 31 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 27 Dec 2024 (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.
A quality assessment of the level of H. pylori diagnosis and treatment in mainland China's Direct-to-consumer telemedicine (DTCT) was conducted by means of Unannounced standardized patients (USPs).
Detailed description
Direct-to-consumer telemedicine (DTCT) refers to a model in which doctors provide medical advice and services directly to patients through the Internet and communication technologies. Under the background of globalization and information age, DTCT, as an innovative medical service model, is gradually changing the traditional face of the medical industry. Especially in today's highly developed information and network, telemedicine service has become an important way to improve the accessibility of medical services, reduce medical costs, and optimize the allocation of medical resources. In China, with the in-depth implementation of the Healthy China strategy, DTCT is regarded as a key link to deepen medical reform and build a new medical service system. In 2018, the Chinese government began to introduce a series of DTCT policy measures to promote the development of telemedicine. By June 2022, China has approved and set up more than 1,700 Internet hospitals, initially forming an integrated online and offline medical services2. As of February 2024, China's National Health Commission has approved the establishment of more than 2,700 Internet hospitals across the country. In addition to the Internet hospitals dominated by physical hospitals, the enterprise-led Internet medical consulting platform has also gradually flourished and gradually occupied a large market share.
The speed of development of DTCT is encouraging, but the quality of care in DTCT is more uncertain. In 2024, a Chinese study published was the first to evaluate multi-disease online diagnosis and treatment services offered on Chinese Internet diagnosis and treatment platforms, using anonymous standardized patients. The study found that the current quality of Internet diagnosis and treatment services is not ideal: out of 170 anonymous consultations, the access success rate is only 63.5% (108/170); Of the visits successfully completed, only 49 consultations (45%) resulted in a correct diagnosis. In terms of physician adherence to the guidelines, the rate of completion of consultation and disposal was 15% and 31%, respectively.
Helicobacter pylori (Hp) infection is a common gastrointestinal disease, which is closely related to the occurrence of gastritis, peptic ulcer, gastric cancer and other diseases. Globally, 43.1% of the population is infected with Helicobacter pylori. In China, the infection rate is also close to 50%. Hp infection has a huge demand for treatment, and it also faces many problems such as complicated treatment plan. Direct-to-consumer telemedicine services offer new possibilities for the treatment of Hp infection, greatly facilitating patients, especially those in remote areas and primary care facilities. However, there is uncertainty in the quality of H. pylori treatment in telemedicine services.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Other: Background of different SP informationSp was asked with the following baseline information: 1. 20 years of age and gender; 2. positive urea breath test; 3. no symptoms; 4. no family history of gastric cancer; 5. gastroscopy: non-atrophic gastritis; 6. no treatments; and 7. no history of drug allergies. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Undeclared Standardized patient (USP) usually refers to a teaching tool used in medical education and training. These standardized patients are trained actors who simulate the conditions, symptoms, and emotional responses of real patients to help physicians improve their clinical skills. In the "undeclared" scenario, these standardized patients may not reveal their identity at the outset, but participate in training or evaluation as real patients, allowing medicine to diagnose and treat without prior preparation. This approach can more realistically simulate the clinical environment and help improve clinical thinking skills, communication skills and understanding of patients. It is expected that 10 research assistants will be included for USP training.
Key inclusion criteria (2 listed)
- An Internet hospital dominated by physical hospitals in the seven geographical regions of gastroenterology specialty reputation shortlisted by the Hospital Research Institute of Fudan University in China
- Be included in the top 20 enterprise-led Internet medical consulting platforms based on popularity and user recognition
Key exclusion criteria (2 listed)
- Physical hospitals without Internet hospitals
- The entity hospital of the Internet hospital can only be revisited
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 |
|---|---|---|
| Background of different SP informationSp was asked with the following baseline information: 1. 50 years of age and gender; 2. positive urea breath test; 3. asymptomatic; 4. family history of gastric cancer; 5. gastroscopy: atrophic gastritis; 6. untreated; and 7. no history of drug allergies. | Other | Group 1 |
Primary outcome
Guidelines compliance
Time frame: 3 months
For the doctor's inquiry through SP, the doctor's answer will be scored against the current guidelines, and the correct answer according to the guidelines will get the corresponding score, out of 10 points. Adherence to the physician's guidelines will be judged by the high or low scores assessed.
Patient satisfaction
Time frame: 3 months
Through the SP for the doctor's inquiry, the doctor's attitude will be scored, and the corresponding score will be obtained. The patient's satisfaction with the physician will be judged by the high or low score of the assessment
1 secondary outcome
Response rate
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2025.
- Derived from this study: PubMed 42464062Duan M, Ju KP, Yang XY, Li YQ, Li YY, Kong QZ, Zuo XL. Quality of Helicobacter pylori Infection Management Through Telemedicine: A Nationwide Cross-Sectional Study. J Dig Dis. 2026 Jul 16. doi: 10.1111/1751-2980.70061. Online ahead of print.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Helicobacter Pylori Infection, run by Shandong University 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 2 inclusion and 2 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: finished, as of the sponsor's last update on 19 Feb 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Guidelines compliance (time frame: 3 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 NCT06749873, 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 19 Feb 2025.