None listed
Conditions
Brief summary
We hypothesize that an mHealth application supporting MDR-TB patients by providing effective health information and enhanced health system support when they experience adverse events (the intervention), will improve their clinical outcomes compared to patients who do not utilize such an application (standard care). The primary objective of this study is to evaluate the effectiveness of a ‘mHealth’ digital adverse event support intervention, compared to “standard care” (without the mHealth intervention), upon treatment success (comprising treatment completion and/or bacteriological cure), among patients with MDR-TB treated in the PMDT program. The use of an mHealth application could potentially serve as a scalable platform to support MDR-TB patients during treatment, ideally reducing the occurrence of Grade 3 and 4 AEs through better identification and management of Grade 1 and 2 AE’s. The study will provide valuable evidence for MDRTB programmes globally on strategies for improving patient management and clinical outcomes.
Interventions
Patients randomized into the intervention arm, in addition to standard care practices, will have a mobile application downloaded onto their smartphones to support their treatment journey. Patients who do not have a smartphone will be loaned one as part of the study. The application was specifically designed for the study and will allow patients direct communication with their designated healthcare worker and provide a platform to report their medication adherence and identification of potential
Patients randomized into the intervention arm, in addition to standard care practices, will have a mobile application downloaded onto their smartphones to support their treatment journey. Patients who do not have a smartphone will be loaned one as part of the study. The application was specifically designed for the study and will allow patients direct communication with their designated healthcare worker and provide a platform to report their medication adherence and identification of potential treatment adverse events on a daily basis. The application will also allow healthcare workers to support patients through direct messaging and communicating selected treatment monitoring indicators as they become available, directly on the application. The application is intended to provide a 'bridge' for communication between patients and healthcare workers outside their routine visits; this will allow for more prompt identification of treatment adherence problems or investigation of potential adverse events, ultimately improving successful treatment outcomes. Patients will be encouraged to use the App daily for the duration of their treatment (8-11 months for short regimen or 18-20 months on long regimen) Antibiotic treatment is in accordance with the guidelines of the Vietnam National Tuberculosis Program. We have also created an analytics platform on a 'web-based' version fo the App to monitor patient and healthcare usage of the App. In addition, their are daily push-notification reminders to patients and healthcare workers to use and respond to actions on the App.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Aged greater than or equal to 15 years - Have a diagnosis of bacteriologically confirmed pulmonary and/or extrapulmonary rifampicin resistant (RR) or multidrug-resistant (MDR)-TB - Have commenced MDR-TB treatment within the previous 30 days - Demonstrate the ability to operate simple functions on a smartphone (including entering a passcode, opening an application and making a phone call)
Exclusion criteria
- Inability to provide written informed consent (e.g. due to a significant communication impairment) - Do not intend to receive treatment within participating provinces over the subsequent 12 month period - Another person residing within the same household, at least one day per week, has already been enrolled and randomized within this study.
Outcome results
None listed