Improving tuberculosis patients’ treatment adherence via electronic monitors and an app versus usual care in Tibet: a pragmatic randomised controlled trial
Background: Poor treatment adherence is a serious challenge to effective tuberculosis (TB) control in Tibet. This study aims to evaluate the effectiveness of using new technologies, including electronic monitors (e-monitors) and a smartphone app, to improve treatment adherence among new pulmonary TB patients in Tibet, China.
Methods: This is a prospective, pragmatic, multicentre, individual-randomized controlled trial with blinded outcome evaluation, and unblinded treatment. New pulmonary TB patients of three counties/districts in Shigatse, Tibet have been randomized to either the intervention or control arm in a 1:1 ratio at the time of their diagnoses since December 2018. All patients in both arms were treated according to the WHO standard TB treatment regimens and China National TB program guidelines, and received their medicines in e-monitors which could report their medication adherence history to the server every day. Additionally, in the intervention arm, e-monitors could remind patients of taking medicines with recorded human voice and share the medication adherence history with health staff via a smartphone app so that video observed treatment could be provided when adherence was problematic. Medication adherence data were collected through the server for interim analysis.
Results: We here report the trial progress by the end of March 2020. We have recruited 123 eligible patients, of which 73 were allocated in the intervention arm and 50 in the control arm, with 46/27 patients (intervention/control) still on treatment. Total planned doses were 10,203 in the intervention arm and 7,295 in the control arm. Medication adherence rate was significantly higher in intervention arm (98.9%) than in control arm (40.0%) with p value less than 0.05. We report the responses of applying the e-application for TB patients during the COVID outbreaks.
Conclusion: Interim analysis results implied that electronic monitor and its app function improves medication adherence among TB patients and becomes better accepted during the COVID outbreaks.