Trial name or title |
Cluster randomized trial of using mobile text messaging and a medication monitor in tuberculosis (TB) case management |
Methods |
Study design: Cluster randomized non‐blinded controlled trial Inclusion criteria:
TB patients, smear‐positive or smear‐negative, recruited from the study clusters (county/district).
Willing to participate in the study.
Conscious without any mental disease.
Conscious without any visual, auditory, or language impairment.
At least 18 years old.
Patient or family member is able to read a SMS text messages and use medication monitor after training.
Exclusion criteria:
Does not meet inclusion criteria.
Patients with TB pleurisy.
Patients with no sputum smear data at TB diagnosis.
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Participants |
Target sample size: 4176 participants (116 per cluster; 9 clusters per arm; 4 arms); age minimum: N/A; age maximum: N/A; gender: N/A |
Interventions |
Mobile phone reminder.
Medication monitor.
Mobile phone and medication monitor.
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Outcomes |
Primary:
The mean proportion of months a patient has at least 3 doses missed (this is based on pill count data from the medication monitor box).
Secondary:
The mean proportion of months a patient has at least 7 doses missed.
The mean proportion of overall missed doses.
Proportion of patients defined as non‐adherent (at least 10% of doses missed).
Proportion of patients defaulting during TB treatment.
Proportion of smear positive TB cases who become smear negative at 2 months.
The proportion of patients with treatment outcome of cure or completed treatment.
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Starting date |
Date of registration: 21 July 2011 Last refreshed on: 20 January 2014 Date of first enrolment: 1 June 2011 Recruitment status: Completed/not recruiting |
Contact information |
URL:http://isrctn.org/ISRCTN46846388 Shiwen Jiang China Center for Disease Control and Prevention No. 155 Changbai Road Changping District 102206 Beijing China |
Notes |
Study ID: ISRCTN46846388 Register: ISRCTN Location: China
Source of funding: Bill and Melinda Gates Foundation (Grant ref: 51914) |