Study on the Management Model of "Home Treatment" for Tuberculosis Patients

NCT ID: NCT03967353

Last Updated: 2019-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-22

Study Completion Date

2022-12-31

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.

Conditions

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Tuberculosis, Pulmonary

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Routine Treatment Group

Routine treatment group(6 months treatment regimen-2HRZE/4HR); Routine health education; Dose-taken supervised by family members

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention Group

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.

Group Type EXPERIMENTAL

New management mode intervention

Intervention Type BEHAVIORAL

Patients in routine treatment group use "TB assistant APP". Medical staff strengthen health promotion of the patients,including, infection control, doctor-patient communication, etc.

Interventions

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New management mode intervention

Patients in routine treatment group use "TB assistant APP". Medical staff strengthen health promotion of the patients,including, infection control, doctor-patient communication, etc.

Intervention Type BEHAVIORAL

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

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Beijing Chest Hospital

OTHER

Sponsor Role lead

Responsible Party

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FengLing Mi

vice director of office of academic research

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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fengling Mi, Master

Role: STUDY_DIRECTOR

Beijing Chest Hospital, Capital Medical University

Locations

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Beijing Chest Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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xiaoying Jiang, Ph.D

Role: CONTACT

861089509298

Facility Contacts

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di zhang, master

Role: primary

861089509298

Other Identifiers

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D 181100000418002

Identifier Type: -

Identifier Source: org_study_id

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