Tuberculosis, PulmonaryNCT03967353
Study on the Management Model of "Home Treatment" for Tuberculosis Patients
A study testing New management mode intervention in people with Tuberculosis, Pulmonary, run by Beijing Chest Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Tuberculosis, Pulmonary
- What is being tested?
- New management mode intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteChina
- Study dates
- 22 Mar 2018to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pathogenic Comfirmed Positive TB patients New Pathogenic Positive Pulmonary Tuberculosis Patients Treated by Home Treatment TB assistant APP user
Who cannot join
- Unconscious Unable to answer questions
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Chest Hospital
Beijing, Beijing Municipality, 101149
di zhang, master, 861089509298, kyb6295@sina.com
fengling Mi, master
About this study
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.
- Conditions
- Tuberculosis, Pulmonary
- Being tested
- New management mode intervention
- Keywords
- Tuberculosis, Home Treatment Management, Infection Control
- Medical subject headings
- Tuberculosis, Pulmonary, Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New management mode interventionBehavioural
Patients in routine treatment group use "TB assistant APP". Medical staff strengthen health promotion of the patients,including, infection control, doctor-patient communication, etc.
| Study group | Role | What they receive |
|---|---|---|
| Routine Treatment Group | No intervention | Routine treatment group(6 months treatment regimen-2HRZE/4HR); Routine health education; Dose-taken supervised by family members |
| Intervention Group | Experimental | 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. Receives: Behavioral: New management mode intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment adherence
to compare the adherence rate of the two groups
Measured: 6 months for each patient
Secondary outcomes (1)
treatment success rate
to compare the success rate of the two groups
Measured: 6 months for each patient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start22 Mar 2018
- Primary completionMar 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Chest Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FengLing Mi, Beijing Chest Hospital
- Investigators
- fengling Mi, Master, Study director, Beijing Chest Hospital, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967353
- Sponsor's protocol ID
- D 181100000418002
- Status last verified
- May 2019
- First submitted
- 23 May 2019
- Last updated
- 30 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To share the data to main researchers.
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Management Model of "Home Treatment" for Tuberculosis Patients
- ClinicalTrials.gov ID
- NCT03967353
- Acronym / sponsor ID
- D 181100000418002
- Conditions
- Tuberculosis, Pulmonary
- Keywords
- Tuberculosis, Home Treatment Management, Infection Control
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Beijing Chest HospitalUniversity, hospital or other
- Study start
- 22 Mar 2018 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 30 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Routine Treatment Group | No intervention | –Routine treatment group(6 months treatment regimen-2HRZE/4HR); Routine health education; Dose-taken supervised by family members |
| Intervention Group | Experimental | Behavioral: New management mode interventionUsing 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Pathogenic Comfirmed Positive TB patients New Pathogenic Positive Pulmonary Tuberculosis Patients Treated by Home Treatment TB assistant APP user
Key exclusion criteria (2 listed)
- Unconscious Unable to answer questions
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New management mode interventionPatients in routine treatment group use "TB assistant APP". Medical staff strengthen health promotion of the patients,including, infection control, doctor-patient communication, etc. | Behavioural | Intervention Group |
Primary outcome
treatment adherence
Time frame: 6 months for each patient
to compare the adherence rate of the two groups
1 secondary outcome
treatment success rate
Time frame: 6 months for each patient
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2019.
- Individual participant dataSharing planned: No. To share the data to main researchers.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
fengling Mi, Master study director
Beijing Chest Hospital, Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New management mode intervention in people with Tuberculosis, Pulmonary, run by Beijing Chest Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact xiaoying Jiang, Ph.D (861089509298, kyb6295@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment adherence (time frame: 6 months for each patient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2019.