UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038653 |
|---|---|
| Receipt number | R000044046 |
| Scientific Title | The Usefulness of a Cross-border Tuberculosis Patient Referral Mechanism in Asia |
| Date of disclosure of the study information | 2019/11/21 |
| Last modified on | 2025/05/26 10:07:10 |
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Basic information
Public title
The Usefulness of a Cross-border Tuberculosis Patient Referral Mechanism in Asia
Acronym
The Usefulness of a Cross-border Tuberculosis Patient Referral Mechanism in Asia
Scientific Title
The Usefulness of a Cross-border Tuberculosis Patient Referral Mechanism in Asia
Scientific Title:Acronym
Bridge TB Care
Region
| Japan | Asia(except Japan) |
Condition
Condition
tuberculosis
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the study is to establish a cross-border TB patient referral mechanism in Asia and to evaluate its effectiveness through the status of the TB patients referred on the access to health facilities as well as on the TB treatment outcomes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
TB treatment success rate (%) after return to the original home country
Key secondary outcomes
TB patient access rate (%) after return to the orignal home country
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
A cross-border TB patient Referral Mechanism:
i) The pathway of the mechanism in Japan
a) To make the mechanism publicly known through the home page of the Research Institute of Tuberculosis (RIT), JATA, Tokyo, Japan.
b) A public health center / a medical institution in Japan initially coordinates with the RIT through phone/fax/e-mail, followed by sending a TB patient referral form and an informed consent form to the RIT.
c) The RIT in Japan contacts with a relevant NTP staff at the country where the TB patient returns, asking to search a suitable health facility that the TB patient should access after he/she goes back, and to monitor his/her treatment status.
d) The RIT in Japan communicate with the public health center / the medical institution in Japan to provide the treatment status of the TB patient referred to his/her home country.
ii) The pathway of the mechanism in the TB patient home country:
a) The NTP concerned asks relevant agencies such as regional / provincial / city health office to search a suitable health center / medical institution that the TB patient should access.
b) The NTP concerned collect information about the TB patient treatment status monthly or bi-monthly through the relevant agencies, then forward the information to the RIT via e-mail.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
All of the TB patients including the latent TB infection patients who were born in either of the four countries, i.e., China, Viet Nam, the Philippines, South Korea, and Myanmar, are diagnosed from April 2019 till March 2012 in Japan, are willing to return back to their home country during the treatment, provide the informed consent form, and are 18 years old and above are eligible to be involved in the study.
Key exclusion criteria
All TB patients who do not fall in any of the criteria above.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | OHKADO |
| Middle name | |
| Last name | AKIHIRO |
Organization
Research Institute of Tuberculosis (RIT), Japan Anti-Tuberculosis Association (JATA)
Division name
Department of Epidemiology and Clinical Research
Zip code
204-8533
Address
Matsuyama 3-1-24, Kiyose, Tokyo
TEL
042-493-3090
rit.epi.9305@jata.or.jp
Public contact
Name of contact person
| 1st name | OHKADO |
| Middle name | |
| Last name | AKIHIRO |
Organization
Research Institute of Tuberculosis (RIT), Japan Anti-Tuberculosis Association (JATA)
Division name
Department of Epidemiology and Clinical Research
Zip code
204-8533
Address
Matsuyama 3-1-24, Kiyose, Tokyo
TEL
042-493-3090
Homepage URL
rit.epi.9305@jata.or.jp
Sponsor or person
Institute
Research Institute of Tuberculosis (RIT), Japan Anti-Tuberculosis Association (JATA)
Institute
Department
Personal name
Funding Source
Organization
the Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Tuberculosis (RIT), Japan Anti-Tuberculosis Association (JATA)
Address
Matsuyama 3-1-24, Kiyose, Tokyo
Tel
042-493-5711
kenkyushien@jata.or.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 11 | Month | 21 | Day |
Related information
URL releasing protocol
http://dx.doi.org/10.5588/pha.23.0052
Publication of results
Published
Result
URL related to results and publications
http://dx.doi.org/10.5588/pha.23.0052
Number of participants that the trial has enrolled
135
Results
83.0% (112 / 135) were confirmed to have accessed a medical facility in the destination country.
TB Treatment success rate among 102 cases whose expected treatment end date was due by July 31, 2023: 85.3% (87 / 102).
Treatment outcome confirmation methods among those whose treatment outcomes were confirmed (87 cases)
-By official confirmation (i.e., by the National TB Control programme, health center, private or public medical facilities): 49 cases (56.3%)
Results date posted
| 2023 | Year | 12 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
As of July 2023, the research team had received requests for cross-border referrals of 156 patients with TB. After excluding those who had cancelled their travel, were still waiting for departure, had already finished their treatment before departure or had latent TB infections, we enrolled 135 foreign-born patients with TB from 11 countries, including 14 patients with rifampicin- or multidrug-resistant TB (RR/MDR-TB).
Participant flow
Public health centres that provided care to patients with TB in Japan initially contacted the RIT, Tokyo, using phone or email, and subsequently, sent a patient referral form and informed consent form to the RIT. Subsequently, the RIT contacted the relevant NTP staff member in the destination country to identify a suitable health facility to be accessed upon return. The engaged NTP staff consulted relevant administrative bodies, such as regional, provincial or city health offices, to identify an appropriate health centre or medical facility for the patient. In collaboration with local assistants assigned by the RIT, RIT staff collected information about the patient's healthcare access and treatment outcomes. The RIT staff and the local assistants communicated with patients with TB via social networking services (SNS) such as Facebook Messenger and LINE so that they could assist patients and monitor their treatment status in their home countries. Before their departure, the RIT staff informed the patient through the Japanese health centre staff of the medical facility in the patient's home country. Then, with support from local assistants, the RIT staff communicated with the NTP staff regarding the patient's attendance and treatment outcomes.
Adverse events
No special note identified.
Outcome measures
We confirmed that 112 of the 135 patients enrolled were successfully referred to a healthcare facility after returning to their home countries; the Access Rate (AR) was 83.0%. Fifteen of the 23 patients with TB (65.2%) whose access to a healthcare facility could not be confirmed were subsequently lost to follow-up; 102 patients of the 135 patients were due for treatment completion as of the end of July 2023. Of these, we were able to confirm that 87 patients had successfully completed their TB treatment; the tuberculosis treatment success rate (SR) was 85.3%. There were no cases of TB treatment failure, unknown treatment outcomes or deaths.
Of the 87 patients, 49 (56.3%) had their treatment outcomes confirmed using official information or clinical report, such as that provided by the National Tuberculosis Control Programme (NTP) or medical facility staff. In the remaining patients, treatment outcomes were confirmed based on patient self-reports (29.9%) or reports by relatives (13.8%).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 08 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044046
