Video-observed therapy and medication adherence for tuberculosis patients: randomised controlled trial in Moldova

Introduction The effectiveness of video-observed therapy (VOT) for treating tuberculosis (TB) has not been measured in low- and middle-income countries (LMICs), where >95% of TB cases and deaths occur. In this study, we analyse the effectiveness and patient cost-difference of VOT compared to clinic-based directly observed therapy (DOT) in improving medication adherence in Moldova, a LMIC in Eastern Europe. Methods The study was a two-arm individually randomised trial with 197 TB patients (n=99 DOT control group; n=98 VOT treatment group; multidrug-resistant TB cases were excluded). The primary outcome was observed medication adherence, measured by the number of days that a patient failed to be observed adhering to medication for every 2-week period during the course of their treatment. Results VOT significantly decreased nonadherence by 4 days (95% CI 3.35–4.67 days, p<0.01) per 2-week period: 5.24 days missed per 2-week period for DOT and 1.29 days for VOT. VOT patients spent MDL 504 (∼EUR 25) (95% CI MDL 277–730, p<0.01) and 58 h (95% CI 48–68 h, p<0.01) less on their treatment. In addition, VOT increased self-reported satisfaction with treatment. We found no significant results pertaining to treatment success, patient wellbeing or patient employment status and some evidence of an increase in side-effects. Discussion In this trial, VOT increased observed medication adherence for TB patients in Moldova, a LMIC, when compared to clinic-based DOT. Additionally, VOT significantly reduced the time and money patients spent on their treatment. In this RCT, patients were assigned to either in-person observed treatment (as normal) or asynchronous video-observation. Observed medication adherence and satisfaction were improved and loss in patient time and costs during treatment were reduced. https://bit.ly/2Klmf18

[1]  R. Garfein,et al.  Synchronous and asynchronous video observed therapy (VOT) for tuberculosis treatment adherence monitoring and support , 2019, Journal of clinical tuberculosis and other mycobacterial diseases.

[2]  R. Garfein,et al.  Smartphone-enabled video-observed versus directly observed treatment for tuberculosis: a multicentre, analyst-blinded, randomised, controlled superiority trial , 2019, The Lancet.

[3]  D. Falzon,et al.  Evaluating the potential costs and impact of digital health technologies for tuberculosis treatment support , 2018, European Respiratory Journal.

[4]  D. Falzon,et al.  The impact of digital health technologies on tuberculosis treatment: a systematic review , 2018, European Respiratory Journal.

[5]  R. Garfein,et al.  Digital health for the End TB Strategy: developing priority products and making them work , 2016, European Respiratory Journal.

[6]  K. Patrick,et al.  Feasibility of tuberculosis treatment monitoring by video directly observed therapy: a binational pilot study. , 2015, The international journal of tuberculosis and lung disease : the official journal of the International Union against Tuberculosis and Lung Disease.

[7]  D. Falzon,et al.  The role of eHealth and mHealth in tuberculosis and tobacco control: a WHO/ERS consultation , 2015, European Respiratory Journal.

[8]  P. Garner,et al.  Directly observed therapy for treating tuberculosis. , 2015, The Cochrane database of systematic reviews.

[9]  Pamala A. Pawloski,et al.  Patient Characteristics Associated with Medication Adherence , 2013, Clinical Medicine & Research.

[10]  W. Shrank,et al.  Association between different types of social support and medication adherence. , 2012, The American journal of managed care.

[11]  L. Hiller,et al.  The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation , 2007, Health and quality of life outcomes.

[12]  T. Frieden,et al.  Promoting adherence to treatment for tuberculosis: the importance of direct observation. , 2007, Bulletin of the World Health Organization.

[13]  A. Lippman Adherence to medication. , 2005, The New England journal of medicine.

[14]  C. Dolea,et al.  World Health Organization , 1949, International Organization.

[15]  R. Evans European Centre for Disease Prevention and Control. , 2014, Nursing standard (Royal College of Nursing (Great Britain) : 1987).