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Tuberculosis Treatment Adherence Using Digital Reminders
- BDCTR ID
- BDCTR-2026-000085
- Sponsor
- Bangladesh Medical University
- Information provided by
- Dr Afroza Sultana (Responsible Party)
- Last Update Posted
- 2026-07-28
Completed
No longer looking for participants
Results Overview
Conditions
- Tuberculosis
Intervention/Treatment
- Behavioral: Digital adherence technology with SMS
Other Study ID Numbers
BMU-MED-2026-005
Study Design
- Allocation :
- Randomized
- Interventional Model :
- Parallel Assignment
- Masking :
- None (Open Label)
- Primary Purpose :
- Treatment
Enrollment (Estimated)
Study Type
Study Record Dates
These dates track the progress of study record and summary results submissions to the registry. Study records and reported results are reviewed by the Registry Office to make sure they meet specific quality control standards before being posted on the public website.
Study Registration Dates
First Submitted that Met QC Criteria
First Posted
Results Reporting Dates
Results First Posted
Study Record Updates
Last Update Submitted that Met QC Criteria
Last Update Posted
Last Verified
Participant Flow
Recruitment Details
Adults starting first-line tuberculosis treatment were enrolled at Rangpur Medical College Hospital between September 2025 and February 2026.
Pre-assignment Details
[Not Specified]
Period Title: Overall study
| Arm/Group Title | Digital adherence | Directly observed therapy |
|---|---|---|
| Arm/Group Description | Digital adherence technology with daily SMS reminders. | Standard directly observed therapy. |
| Started | 372 | 368 |
| NOT COMPLETED | 31 | 50 |
| Completed | 341 | 318 |
| Not Completed | 31 | 50 |
| Reason Not Completed | ||
| Lost to Follow-up | 24 | 39 |
| Adverse Event | 7 | 11 |
Baseline Characteristics
| Arm/Group Title | Digital adherence | Directly observed therapy | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Overall Number of Baseline Participants | 372 | 368 | — |
Baseline Analysis Population Description
[Not Specified]
Age, ContinuousMean (Standard Deviation) | Unit of measure: years
| Arm/Group Title | Digital adherence | Directly observed therapy | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Number Analyzed | 372 participants | 368 participants | — |
| Age, Continuous | 38.2 (12.1) | 39.0 (11.8) | — |
Sex: Female, MaleMeasure Type: Count of Participants | Unit of measure: Participants
| Arm/Group Title | Digital adherence | Directly observed therapy | Total |
|---|---|---|---|
| Arm/Group Description | Total of all reporting groups | ||
| Number Analyzed | 372 participants | 368 participants | — |
| Female | 151 40.6% | 149 40.5% | 300 |
| Male | 221 59.4% | 219 59.5% | 440 |
Outcome Measures
1. Treatment completion rateType: Primary | Time Frame: End of therapy, up to 6 months
Description
Proportion of participants completing the full course of treatment.
Analysis Population Description
[Not Specified]
| Arm/Group Title | Digital adherence | Directly observed therapy |
|---|---|---|
| Overall Number of Participants Analyzed | 372 | 368 |
| Measure Type: Number | Unit of Measure: percentage of participants | ||
| Treatment completion rate | 91.7 | 86.4 |
2. Loss to follow-upType: Secondary | Time Frame: Up to 6 months
Description
[Not Specified]
Analysis Population Description
[Not Specified]
| Arm/Group Title | Digital adherence | Directly observed therapy |
|---|---|---|
| Overall Number of Participants Analyzed | — | — |
| Measure Type: Number | Unit of Measure: percentage of participants | ||
| Loss to follow-up | 6.5 | 10.6 |
Adverse Events
Time Frame
Up to 6 months
Adverse Event Reporting Description
[Not Specified]
All-Cause Mortality
| Arm/Group Title | Digital adherence | Directly observed therapy |
|---|---|---|
| Affected / at Risk (%) | Affected / at Risk (%) | |
| Total | — | — |
Serious Adverse Events
| Arm/Group Title | Digital adherence | Directly observed therapy | ||
|---|---|---|---|---|
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 9/372 (2.42%) | 12/368 (3.26%) | ||
| Hepatobiliary disorders | ||||
| Drug-induced hepatotoxicity | 6/372 (1.61%) | 8/368 (2.17%) | ||
| Skin and subcutaneous tissue disorders | ||||
| Severe cutaneous reaction | 3/372 (0.81%) | 4/368 (1.09%) | ||
Other (Not Including Serious) Adverse Events
5% Frequency Threshold for Reporting Other Adverse Events
| Arm/Group Title | Digital adherence | Directly observed therapy | ||
|---|---|---|---|---|
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 61/372 (16.40%) | 68/368 (18.48%) | ||
| Gastrointestinal disorders | ||||
| Nausea | 41/372 (11.02%) | 45/368 (12.23%) | ||
| Nervous system disorders | ||||
| Peripheral neuropathy | 20/372 (5.38%) | 23/368 (6.25%) | ||
Limitations and Caveats
[Not Specified]
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
National Tuberculosis Control Programme