People–centred care versus clinic–based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial
Abstract Background WHO’s directly observed therapy (DOT) strategy for tuberculosis (TB) treatment depends upon a well–organized healthcare system. This study sought to evaluate the effectiveness of self-administered drug intake supported by a family member versus in-clinic DOT. Methods This open–la...
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doaj-9316f08352fe43c09407ac98906301fb2020-11-25T03:04:37ZengBMCBMC Pulmonary Medicine1471-24662020-04-0120111010.1186/s12890-020-1141-yPeople–centred care versus clinic–based DOT for continuation phase TB treatment in Armenia: a cluster randomized trialVahe Khachadourian0Nune Truzyan1Arusyak Harutyunyan2Varduhi Petrosyan3Hayk Davtyan4Karapet Davtyan5Martin van den Boom6Michael E. Thompson7Avedisian Onanian Centre for Health Services Research & Development, Gerald and Patricia Turpanjian School of Public Health, American University of ArmeniaAvedisian Onanian Centre for Health Services Research & Development, Gerald and Patricia Turpanjian School of Public Health, American University of ArmeniaAvedisian Onanian Centre for Health Services Research & Development, Gerald and Patricia Turpanjian School of Public Health, American University of ArmeniaAvedisian Onanian Centre for Health Services Research & Development, Gerald and Patricia Turpanjian School of Public Health, American University of ArmeniaNational Tuberculosis Control Centre, Ministry of Health of the Republic of ArmeniaNational Tuberculosis Control Centre, Ministry of Health of the Republic of ArmeniaJoint Tuberculosis, HIV & Viral Hepatitis Programme, Division of Health Emergencies and Communicable Diseases, WHO/EuropeDepartment of Public Health Sciences, University of North Carolina at CharlotteAbstract Background WHO’s directly observed therapy (DOT) strategy for tuberculosis (TB) treatment depends upon a well–organized healthcare system. This study sought to evaluate the effectiveness of self-administered drug intake supported by a family member versus in-clinic DOT. Methods This open–label, nationally-representative stratified cluster randomized controlled non–inferiority trial with two parallel equal arms involved drug–susceptible pulmonary TB patients in the continuation treatment phase. We randomly assigned outpatient–TB–centres (52 clusters) to intervention and control arms. The intervention included an educational/counseling session to enhance treatment adherence; weekly visits to outpatient–TB–centres to receive medication, and daily SMS medication reminders and phone calls to track adherence and record side effects. Controls followed clinical DOT at Outpatient–TB–centres. Both groups participated in baseline and 4–5 months follow–up surveys. The trial’s non–inferiority comparisons include: treatment success as the clinical (primary) outcome and medication adherence (self–reported), knowledge, depressive symptoms, stigma, quality of life, and social support as non–clinical (secondary) outcomes. Results Per–protocol analysis showed that the intervention (n = 187) and control (n = 198) arms achieved successful treatment outcome of 92.0 and 92.9%, respectively, indicating that the treatment success in the intervention group was non–inferior to DOT. Knowledge, depression, stigma, quality of life, and social support also showed non–inferiority, demonstrating substantial improvement over time for knowledge (change in the intervention = 1.05: 95%CL (0.49, 1.60); change in the control = 1.09: 95%CL (0.56, 1.64)), depression score (change in the intervention = − 3.56: 95%CL (− 4.99, − 2.13); change in the control = − 1.88: 95% CL (− 3.26, − 0.49)) and quality of life (change in the intervention = 5.01: 95%CL (− 0.64, 10.66); change in the control = 7.29: 95%CL (1.77, 12.81)). The intervention resulted in improved treatment adherence. Conclusions This socially empowering alternative strategy might be a preferable alternative to DOT available to patients in Armenia and in other countries. Further research evaluating cost effectiveness of the intervention and generalizability of the results is warranted. Trial registration Clinicaltrials.gov: NCT02082340, March 10, 2014.http://link.springer.com/article/10.1186/s12890-020-1141-yPatient-Centreed careTuberculosisCounselling |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Vahe Khachadourian Nune Truzyan Arusyak Harutyunyan Varduhi Petrosyan Hayk Davtyan Karapet Davtyan Martin van den Boom Michael E. Thompson |
spellingShingle |
Vahe Khachadourian Nune Truzyan Arusyak Harutyunyan Varduhi Petrosyan Hayk Davtyan Karapet Davtyan Martin van den Boom Michael E. Thompson People–centred care versus clinic–based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial BMC Pulmonary Medicine Patient-Centreed care Tuberculosis Counselling |
author_facet |
Vahe Khachadourian Nune Truzyan Arusyak Harutyunyan Varduhi Petrosyan Hayk Davtyan Karapet Davtyan Martin van den Boom Michael E. Thompson |
author_sort |
Vahe Khachadourian |
title |
People–centred care versus clinic–based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial |
title_short |
People–centred care versus clinic–based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial |
title_full |
People–centred care versus clinic–based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial |
title_fullStr |
People–centred care versus clinic–based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial |
title_full_unstemmed |
People–centred care versus clinic–based DOT for continuation phase TB treatment in Armenia: a cluster randomized trial |
title_sort |
people–centred care versus clinic–based dot for continuation phase tb treatment in armenia: a cluster randomized trial |
publisher |
BMC |
series |
BMC Pulmonary Medicine |
issn |
1471-2466 |
publishDate |
2020-04-01 |
description |
Abstract Background WHO’s directly observed therapy (DOT) strategy for tuberculosis (TB) treatment depends upon a well–organized healthcare system. This study sought to evaluate the effectiveness of self-administered drug intake supported by a family member versus in-clinic DOT. Methods This open–label, nationally-representative stratified cluster randomized controlled non–inferiority trial with two parallel equal arms involved drug–susceptible pulmonary TB patients in the continuation treatment phase. We randomly assigned outpatient–TB–centres (52 clusters) to intervention and control arms. The intervention included an educational/counseling session to enhance treatment adherence; weekly visits to outpatient–TB–centres to receive medication, and daily SMS medication reminders and phone calls to track adherence and record side effects. Controls followed clinical DOT at Outpatient–TB–centres. Both groups participated in baseline and 4–5 months follow–up surveys. The trial’s non–inferiority comparisons include: treatment success as the clinical (primary) outcome and medication adherence (self–reported), knowledge, depressive symptoms, stigma, quality of life, and social support as non–clinical (secondary) outcomes. Results Per–protocol analysis showed that the intervention (n = 187) and control (n = 198) arms achieved successful treatment outcome of 92.0 and 92.9%, respectively, indicating that the treatment success in the intervention group was non–inferior to DOT. Knowledge, depression, stigma, quality of life, and social support also showed non–inferiority, demonstrating substantial improvement over time for knowledge (change in the intervention = 1.05: 95%CL (0.49, 1.60); change in the control = 1.09: 95%CL (0.56, 1.64)), depression score (change in the intervention = − 3.56: 95%CL (− 4.99, − 2.13); change in the control = − 1.88: 95% CL (− 3.26, − 0.49)) and quality of life (change in the intervention = 5.01: 95%CL (− 0.64, 10.66); change in the control = 7.29: 95%CL (1.77, 12.81)). The intervention resulted in improved treatment adherence. Conclusions This socially empowering alternative strategy might be a preferable alternative to DOT available to patients in Armenia and in other countries. Further research evaluating cost effectiveness of the intervention and generalizability of the results is warranted. Trial registration Clinicaltrials.gov: NCT02082340, March 10, 2014. |
topic |
Patient-Centreed care Tuberculosis Counselling |
url |
http://link.springer.com/article/10.1186/s12890-020-1141-y |
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