CClinicalTrials.gg
Status unknownNCT03967353Updated May 30, 2019

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

An interventional study of New management mode intervention in Tuberculosis, Pulmonary, sponsored by Beijing Chest Hospital. Status unknown at 1 site in China. Per ClinicalTrials.gov, last updated 2019-05-30.

Sponsored by Beijing Chest Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2019), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Mar 2018, registered May 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
280
Allocation
Randomized
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Tuberculosis, Pulmonary

Keywords

  • Tuberculosis
  • Home Treatment Management
  • Infection Control
03

In context

Tuberculosis

1,417 studies on the registry are indexed under Tuberculosis; 208 are open to participants now.

This study's planned enrollment of 280 is above the median of 150 across 952 interventional studies indexed under Tuberculosis.

Browse Tuberculosis studies →

Lead sponsor

Beijing Chest Hospital is the lead sponsor of 31 studies on the registry; 13 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

Pathogenic Comfirmed Positive TB patients New Pathogenic Positive Pulmonary Tuberculosis Patients Treated by Home Treatment TB assistant APP user

Exclusion criteria

Exclusion Criteria:

Unconscious Unable to answer questions

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
280 participants (estimated)

Study arms

  • No intervention
    Routine Treatment Group

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

  • Experimental
    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.

    Behavioral: New management mode intervention

Interventions

  • BehavioralNew 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.

06

What researchers measure

Primary outcomes

  1. treatment adherence

    to compare the adherence rate of the two groups

    Time frame: 6 months for each patient

Secondary outcomes

  1. treatment success rate

    to compare the success rate of the two groups

    Time frame: 6 months for each patient

07

Study locations

1 of 1 sites recruiting
  • Beijing Chest Hospital
    Beijing, Beijing 101149, China
    • di zhang, master · Contact · kyb6295@sina.com · 861089509298
    • fengling Mi, master · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No — To share the data to main researchers.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03967353
Lead sponsor
Beijing Chest Hospital
Responsible party
FengLing Mi (vice director of office of academic research, Beijing Chest Hospital) — Principal investigator
First posted
May 30, 2019
Start date
Mar 22, 2018
Primary completion
Mar 2022 (estimated)
Completion
Dec 2022 (estimated)
Last update
May 30, 2019

Study contacts

xiaoying Jiang, Ph.D
Contact
kyb6295@sina.com
861089509298
fengling Mi, Master
study director · Beijing Chest Hospital, Capital Medical University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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