Bracelet- and self-directed observational therapy for control of tuberculosis: study protocol for a cluster randomized controlled trial.

Background: Approximately 80% of global tuberculosis (TB) cases occur in low-resource settings, with little opportunity for TB control. We hypothesized that the rapid increase in smartphone users and advances in digital technology would render bracelet-based applications possible; specifically, that bracelet- and self-directed observational therapy (BSDOT) can be used by patients with TB to ensure adherence to TB medication regimens and by basic village physicians to monitor care. This will ultimately allow TB to be controlled in low-resource environments.

Methods And Design: This study will have three phases: development of a bracelet capable of storing pills and recording adherence to medication regimens; creation of a BSDOT smartphone application capable of supporting reminders to patients and health care interactions between patients and village physicians; and performance of a cluster randomized controlled trial in Hunan Province, China. Patients in the intervention group will receive free bracelets and smartphones, and their daily medication intake will be directed by the smartphones; the control group will receive no intervention. The primary outcome will be the TB treatment result as defined by the World Health Organization (WHO) as follows: Cured, Treatment completed, Treatment failed, Died, Lost to follow-up, Not evaluated, or Treatment success. The secondary outcome will be treatment adherence, defined as the percentage of patients receiving TB treatment who missed fewer than 5% of doses. We will also assess self-reported adherence using the Morisky, Green, and Levine Adherence Scale (MGLS) and evaluate respondents' knowledge about TB and quality of life. A regression model will be used to explore whether the interventions improve drug adherence and other outcome measures. DISCUSSION: This will be a powerful means by which to strengthen TB control and prevent TB, especially multidrug-resistant epidemics of the disease. In addition, our novel smartphone-based tool can be readily adopted for use in low-resource remote environments with limited health care facilities and few economic assets.

Ethics And Dissemination: The protocol has been approved by the Ethics Committee of Xiangya School of Public Health, Central South University (reference number: XYGW-2016-14).

Trial Registration: Chinese Clinical Trial Registry, ID: ChiCTR-IOR-16008424 . Registered on 5 June 2016.