UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056371 |
|---|---|
| Receipt number | R000064407 |
| Scientific Title | Effectiveness of Mobile Phone Application to Improve Medical Outcome Among Tuberculosis Patients in Nepal - An Experimental Study. |
| Date of disclosure of the study information | 2025/10/30 |
| Last modified on | 2024/12/05 15:15:49 |
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Basic information
Public title
Effectiveness of Mobile Phone Application to Improve Medical Outcome Among Tuberculosis Patients in Nepal - An Experimental Study.
Acronym
EMMA-TB Nepal
Scientific Title
Effectiveness of Mobile Phone Application to Improve Medical Outcome Among Tuberculosis Patients in Nepal - An Experimental Study.
Scientific Title:Acronym
EMMA-TB Nepal
Region
| Asia(except Japan) |
Condition
Condition
Infectious conditions
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To improve medication adherence through the use of mobile application among tuberculosis patients in Nepal.
Basic objectives2
Others
Basic objectives -Others
To investigate the effectiveness of SMS-based interventions to improve tuberculosis treatment adherence and cure rates.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
As the study will examine the effectiveness of SMS-based interventions to improve tuberculosis treatment adherence and cure rates. The results of this study will be helpful for those professionals and organizations who are working in designing the interventions programs aimed at improving adherence to tuberculosis treatment and enhancing cure rates.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Intervention Group: This group uses a mobile phone application designed to improve treatment adherence. The app sends daily text reminders to take medication and provides educational content about tuberculosis (TB) and its treatment.
Interventions/Control_2
Control Group: This group receives educational content about TB and its treatment, but does not receive daily text reminders for medication.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The study population will be all newly diagnosed pulmonary TB patients 18-60 years within the first week of diagnosis.
Key exclusion criteria
This study will exclude the patients who are;
Refusing to participate in our study.
Those who do not have smartphone.
Patients with HIV/AIDS/critically ill.
Those who cannot read the text.
If patients involve in another interventional study.
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | Shiva |
| Middle name | |
| Last name | Acharya |
Organization
Kobe University
Division name
Graduate School of Health Sciences, Public Health
Zip code
658-0027
Address
12-5,Ogi 5- Chome Higashinada-ku,Kobe, Hyogo.
TEL
+81-7075819808
shivaacharya47@yahoo.com
Public contact
Name of contact person
| 1st name | Minato |
| Middle name | |
| Last name | Nakazawa |
Organization
Kobe University
Division name
Graduate School of Health Sciences, Public Health
Zip code
654-0142
Address
7-10-2, Suma-ku,Kobe 7-10-2, Suma-ku, Kobe.
TEL
+81-78-796-4551
Homepage URL
minato-nakazawa@people.kobe-u.ac.jp
Sponsor or person
Institute
This study has no external sponsor.
Institute
Department
Personal name
Funding Source
Organization
This study has no external sponsor.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nepal Health Research Council (NHRC)
Address
Ramshah Path, Kathmandu, Nepal
Tel
+977-01-5327460
nhrc@nhrc.gov.np
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
| 2025 | Year | 10 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 11 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 01 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064407
