Effectiveness of electronic reminders to improve medication adherence in tuberculosis patients: a cluster-randomised trial – User Guide

Persistent identifier

10.17037/DATA.4

Description

An anonymised dataset of 4,292 TB patients who gave informed consent to participate in a pragmatic, cluster-randomised trial of 36 districts/counties (clusters) within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China between June 2011 and March 2012. Dataset contains variables on stratified randomisation and cluster code, socio-demographic information, TB treatment outcomes, adherence outcomes, medication monitor problems, mobile phone problems, and the type of patient treatment management initiated (if at all).

Methods

A pragmatic, cluster-randomised trial of 36 districts/counties (clusters) within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China. Clusters were randomised to one of four case-management approaches using stratification and restriction. The four arms were standard of care (control), or receiving adherence reminders from (i) text messages, (ii) an electronic medication monitor or (iii) both. See paper for more details on the intervention definitions. TB patients in these clusters were recruited at the start of treatment and followed up for six months. The primary outcome was the percentage of patient-months on TB treatment where at least 20% of doses were missed as measured by pill count and failure to open the medication monitor. Secondary outcomes included additional adherence measures and standard treatment outcome measures. Interventions were not masked to study staff and patients.

From June 2011- March 2012 a total of 4,292 TB patients gave informed consent. Of these, 61 were reassessed as not having TB by their managing doctor and 58 were switched to a different treatment model within the first month (due to hospitalisation or travel) and were therefore excluded from all analyses. Therefore, 4,173 patients were eligible for the analysis.

Spatial coverage

Data were captured in 36 districts/counties (clusters) within the provinces of Heilongjiang, Jiangsu, Hunan, and Chongqing, China

Temporal coverage

Data were collected between 1 June 2011 and September 2012.

Population

Human population

Privacy

Patients are identified by a unique study number. External identifiers have been removed.

Ethics

The study was approved by the ethics committees of China Center Disease Control (201008) and the London School of Hygiene and Tropical Medicine (5704).

Keywords

tuberculosis treatment, electronic reminders, China, adherence

Language of written material

English

Project Information

Creators

Associated roles

Research Centre/Group

• LSHTM TB Centre
• MRC Tropical Epidemiology Group

Participating Institutions

• National Center for TB Control and Prevention, China Center for Disease Control, Beijing, China
• London School of Hygiene & Tropical Medicine, UK
• Jiangsu Provincial Center for Disease Control and Prevention, Nanjing, Jiangsu, China
• Chongqing Provincial TB dispensary, Chongqing, China
• Heilongjiang Provincial TB dispensary, Harbin, Heilongjiang, China
• Hunan Provincial TB dispensary, Changsha, Hunan, China
• China-Gates Foundation TB Project National Program Management Office, China
• CDC, Beijing, China, Dafeng County Center for Disease Control and Prevention in Jiangsu province, Dafeng, Jiangsu, China
• The Bill & Melinda Gates Foundation Beijing Office, Beijing, China

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