mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial
Introduction The Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART) trial is a randomised controlled trial of using mobile health (mHealth) technologies to improve adherence to medications and management of adverse events (AEs) in people with multidrug-resistant tuber...
Saved in:
| Main Authors: | , , , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-12-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/12/e076778.full |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849314962439143424 |
|---|---|
| author | Virginia Wiseman Binh Hoa Nguyen Viet Nhung Nguyen Guy B Marks Qinglu Cheng Kavindhran Velen Tho Dang Dinh Hoa Vu Thu Thuong Do Thu-Anh Nguyen Chuong Huynh Long Truong-Minh Vu Manisha Yapa Gregory J Fox |
| author_facet | Virginia Wiseman Binh Hoa Nguyen Viet Nhung Nguyen Guy B Marks Qinglu Cheng Kavindhran Velen Tho Dang Dinh Hoa Vu Thu Thuong Do Thu-Anh Nguyen Chuong Huynh Long Truong-Minh Vu Manisha Yapa Gregory J Fox |
| author_sort | Virginia Wiseman |
| collection | DOAJ |
| description | Introduction The Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART) trial is a randomised controlled trial of using mobile health (mHealth) technologies to improve adherence to medications and management of adverse events (AEs) in people with multidrug-resistant tuberculosis (MDR-TB) undergoing treatment in Vietnam. This economic evaluation seeks to quantify the cost-effectiveness of this mHealth intervention from a healthcare provider and societal perspective.Methods and analysis The V-SMART trial will recruit 902 patients treated for MDR-TB across seven participating provinces in Vietnam. Participants in both intervention and control groups will receive standard community-based therapy for MDR-TB. Participants in the intervention group will also have a purpose-designed App installed on their smartphones to report AEs to health workers and to facilitate timely management of AEs. This economic evaluation will compare the costs and health outcomes between the intervention group (mHealth) and the control group (standard of care). Costs associated with delivering the intervention and health service utilisation will be recorded, as well as patient out-of-pocket costs. The health-related quality of life (HRQoL) of study participants will be captured using the 36-Item Short Form Survey (SF-36) questionnaire and used to calculate quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) will be based on the primary outcome (proportion of patients with treatment success after 24 months) and QALYs gained. Sensitivity analysis will be conducted to test the robustness of the ICERs. A budget impact analysis will be conducted from a payer perspective to provide an estimate of the total budget required to scale-up delivery of the intervention.Ethics and dissemination Ethical approval for the study was granted by the University of Sydney Human Research Ethics Committee (2019/676), the Scientific Committee of the Ministry of Science and Technology, Vietnam (08/QD-HDQL-NAFOSTED) and the Institutional Review Board of the National Lung Hospital, Vietnam (13/19/CT-HDDD). Study findings will be published in peer-reviewed journals and conference proceedings.Trial registration number ACTRN12620000681954. |
| format | Article |
| id | doaj-art-05f992f059db40028929f5b80de90014 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2023-12-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-05f992f059db40028929f5b80de900142025-08-20T03:52:16ZengBMJ Publishing GroupBMJ Open2044-60552023-12-01131210.1136/bmjopen-2023-076778mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trialVirginia Wiseman0Binh Hoa Nguyen1Viet Nhung Nguyen2Guy B Marks3Qinglu Cheng4Kavindhran Velen5Tho Dang6Dinh Hoa Vu7Thu Thuong Do8Thu-Anh Nguyen9Chuong Huynh Long10Truong-Minh Vu11Manisha Yapa12Gregory J Fox1312 The Kirby Institute, University of New South Wales, Sydney, New South Wales, AustraliaVietnam National Tuberculosis Control Program, Hanoi, VietnamVietnam National Tuberculosis Control Program, Hanoi, VietnamSchool of Clinical Medicine, University of New South Wales, Sydney, New South Wales, AustraliaKirby Institute, University of New South Wales, Sydney, New South Wales, AustraliaFaculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaWoolcock Institute of Medical Research, Hanoi, Viet NamHanoi University of Pharmacy, Hanoi, VietnamVietnam National Tuberculosis Control Program, Hanoi, VietnamWoolcock Institute of Medical Research, Hanoi, VietnamWoolcock Institute of Medical Research, Hanoi, VietnamHo Chi Minh City Institute for Development Studies, Ho Chi Minh City, VietnamFaculty of Medicine and Health, The University of Sydney, Sydney, New South Wales, AustraliaWoolcock Institute of Medical Research, Hanoi, VietnamIntroduction The Strengthen the Management of Multidrug-Resistant Tuberculosis in Vietnam (V-SMART) trial is a randomised controlled trial of using mobile health (mHealth) technologies to improve adherence to medications and management of adverse events (AEs) in people with multidrug-resistant tuberculosis (MDR-TB) undergoing treatment in Vietnam. This economic evaluation seeks to quantify the cost-effectiveness of this mHealth intervention from a healthcare provider and societal perspective.Methods and analysis The V-SMART trial will recruit 902 patients treated for MDR-TB across seven participating provinces in Vietnam. Participants in both intervention and control groups will receive standard community-based therapy for MDR-TB. Participants in the intervention group will also have a purpose-designed App installed on their smartphones to report AEs to health workers and to facilitate timely management of AEs. This economic evaluation will compare the costs and health outcomes between the intervention group (mHealth) and the control group (standard of care). Costs associated with delivering the intervention and health service utilisation will be recorded, as well as patient out-of-pocket costs. The health-related quality of life (HRQoL) of study participants will be captured using the 36-Item Short Form Survey (SF-36) questionnaire and used to calculate quality-adjusted life-years (QALYs). Incremental cost-effectiveness ratios (ICERs) will be based on the primary outcome (proportion of patients with treatment success after 24 months) and QALYs gained. Sensitivity analysis will be conducted to test the robustness of the ICERs. A budget impact analysis will be conducted from a payer perspective to provide an estimate of the total budget required to scale-up delivery of the intervention.Ethics and dissemination Ethical approval for the study was granted by the University of Sydney Human Research Ethics Committee (2019/676), the Scientific Committee of the Ministry of Science and Technology, Vietnam (08/QD-HDQL-NAFOSTED) and the Institutional Review Board of the National Lung Hospital, Vietnam (13/19/CT-HDDD). Study findings will be published in peer-reviewed journals and conference proceedings.Trial registration number ACTRN12620000681954.https://bmjopen.bmj.com/content/13/12/e076778.full |
| spellingShingle | Virginia Wiseman Binh Hoa Nguyen Viet Nhung Nguyen Guy B Marks Qinglu Cheng Kavindhran Velen Tho Dang Dinh Hoa Vu Thu Thuong Do Thu-Anh Nguyen Chuong Huynh Long Truong-Minh Vu Manisha Yapa Gregory J Fox mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial BMJ Open |
| title | mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial |
| title_full | mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial |
| title_fullStr | mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial |
| title_full_unstemmed | mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial |
| title_short | mHealth application for improving treatment outcomes for patients with multidrug-resistant tuberculosis in Vietnam: an economic evaluation protocol for the V-SMART trial |
| title_sort | mhealth application for improving treatment outcomes for patients with multidrug resistant tuberculosis in vietnam an economic evaluation protocol for the v smart trial |
| url | https://bmjopen.bmj.com/content/13/12/e076778.full |
| work_keys_str_mv | AT virginiawiseman mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT binhhoanguyen mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT vietnhungnguyen mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT guybmarks mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT qinglucheng mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT kavindhranvelen mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT thodang mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT dinhhoavu mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT thuthuongdo mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT thuanhnguyen mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT chuonghuynhlong mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT truongminhvu mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT manishayapa mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial AT gregoryjfox mhealthapplicationforimprovingtreatmentoutcomesforpatientswithmultidrugresistanttuberculosisinvietnamaneconomicevaluationprotocolforthevsmarttrial |