Back to resultsStudy on the Management Model of "Home Treatment" for Tuberculosis Patients
Primary Purpose
Tuberculosis, Pulmonary
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
New management mode intervention
Sponsored by
About this trial
This is an interventional treatment trial for Tuberculosis, Pulmonary focused on measuring Tuberculosis, Home Treatment Management, Infection Control
Eligibility Criteria
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
-
Sites / Locations
- Beijing Chest HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Routine Treatment Group
Intervention Group
Arm Description
Routine treatment group(6 months treatment regimen-2HRZE/4HR); Routine health education; Dose-taken supervised by family members
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.
Outcomes
Primary Outcome Measures
treatment adherence
to compare the adherence rate of the two groups
Secondary Outcome Measures
treatment success rate
to compare the success rate of the two groups
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03967353
Brief Title
Study on the Management Model of "Home Treatment" for Tuberculosis Patients
Official Title
Study on the Management Model of "Home Treatment" for Tuberculosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2018 (Actual)
Primary Completion Date
March 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beijing Chest Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tuberculosis, Pulmonary
Keywords
Tuberculosis, Home Treatment Management, Infection Control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Routine Treatment Group
Arm Type
No Intervention
Arm Description
Routine treatment group(6 months treatment regimen-2HRZE/4HR); Routine health education; Dose-taken supervised by family members
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
New management mode intervention
Intervention Description
Patients in routine treatment group use "TB assistant APP". Medical staff strengthen health promotion of the patients,including, infection control, doctor-patient communication, etc.
Primary Outcome Measure Information:
Title
treatment adherence
Description
to compare the adherence rate of the two groups
Time Frame
6 months for each patient
Secondary Outcome Measure Information:
Title
treatment success rate
Description
to compare the success rate of the two groups
Time Frame
6 months for each patient
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaoying Jiang, Ph.D
Phone
861089509298
Email
kyb6295@sina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
fengling Mi, Master
Organizational Affiliation
Beijing Chest Hospital, Capital Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Beijing Chest Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101149
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
di zhang, master
Phone
861089509298
Email
kyb6295@sina.com
First Name & Middle Initial & Last Name & Degree
fengling Mi, master
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
To share the data to main researchers.
Learn more about this trial
Study on the Management Model of "Home Treatment" for Tuberculosis Patients
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