Study on the Management Model of "Home Treatment" for Tuberculosis Patients
1 other identifier
interventional
280
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
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
Study Start
First participant enrolled
March 22, 2018
CompletedFirst Submitted
Initial submission to the registry
May 23, 2019
CompletedFirst Posted
Study publicly available on registry
May 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedMay 30, 2019
May 1, 2019
3.9 years
May 23, 2019
May 28, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
treatment adherence
to compare the adherence rate of the two groups
6 months for each patient
Secondary Outcomes (1)
treatment success rate
6 months for each patient
Study Arms (2)
Routine Treatment Group
NO INTERVENTIONRoutine treatment group(6 months treatment regimen-2HRZE/4HR); Routine health education; Dose-taken supervised by family members
Intervention Group
EXPERIMENTALUsing 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.
Interventions
Patients in routine treatment group use "TB assistant APP". Medical staff strengthen health promotion of the patients,including, infection control, doctor-patient communication, etc.
Eligibility Criteria
You may qualify if:
- Pathogenic Comfirmed Positive TB patients New Pathogenic Positive Pulmonary Tuberculosis Patients Treated by Home Treatment TB assistant APP user
You may not qualify if:
- Unconscious Unable to answer questions
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Beijing Chest Hospital
Beijing, Beijing Municipality, 101149, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
fengling Mi, Master
Beijing Chest Hospital, Capital Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- vice director of office of academic research
Study Record Dates
First Submitted
May 23, 2019
First Posted
May 30, 2019
Study Start
March 22, 2018
Primary Completion
March 1, 2022
Study Completion
December 1, 2022
Last Updated
May 30, 2019
Record last verified: 2019-05
Data Sharing
- IPD Sharing
- Will not share
To share the data to main researchers.