Study on the Management Model of Home Treatment for Tuberculosis Patients

Study Overview
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Brief Summary
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This project aims to standardize the management of home treatment for tuberculosis patients, improve the compliance of patients with treatment, reduce the risk of transmission, and study the establishment of home treatment management model for tuberculosis patients.

Detailed Description
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The project intends to optimize the standardized management framework and process of home treatment for tuberculosis patients by introducing mobile Internet technology as a means of patient management and formulating home treatment infection control norms, and ultimately form a management model suitable for home treatment for tuberculosis patients.Through prospective study to evaluate the effect of this model on the treatment compliance of home treatment patients and the impact on tuberculosis infection and incidence of close contacts, so as to further improve the home treatment management model. The research results of this project will provide policy basis for Beijing to formulate home treatment management of tuberculosis progress.

Official Title
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Study on the Management Model of Home Treatment for Tuberculosis Patients

Conditions
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Tuberculosis, Pulmonary

Intervention / Treatment
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* Behavioral: New management mode intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pathogenic Comfirmed Positive TB patients New Pathogenic Positive Pulmonary Tuberculosis Patients Treated by Home Treatment TB assistant APP user Exclusion Criteria: Unconscious Unable to answer questions -
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine Treatment Group<br>Routine treatment group(6 months treatment regimen-2HRZE/4HR); Routine health education; Dose-taken supervised by family members | |
| Experimental: Intervention Group<br>Using mobile technology management means to manage newly treated smear-positive tuberculosis patients, to guide patients'treatment, infection control, doctor-patient communication, and to strengthen health education on infection control of patients. | Behavioral: New management mode intervention<br>* Patients in routine treatment group use TB assistant APP. Medical staff strengthen health promotion of the patients,including, infection control, doctor-patient communication, etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment adherence | to compare the adherence rate of the two groups | 6 months for each patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment success rate | to compare the success rate of the two groups | 6 months for each patient | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tuberculosis, Home Treatment Management, Infection Control