NCT06749873

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
552

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 30, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

December 27, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

November 30, 2024

Last Update Submit

February 18, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    3 months

Secondary Outcomes (1)

  • Response rate

    3 months

Study Arms (1)

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.

Other: Background of different SP information

Interventions

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.

Group 1

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Physical hospitals without Internet hospitals
  • The entity hospital of the Internet hospital can only be revisited

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandoang, China

Location

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 30, 2024

First Posted

December 27, 2024

Study Start

December 1, 2024

Primary Completion

January 31, 2025

Study Completion

January 31, 2025

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations