None listed
Conditions
Brief summary
Objective: To evaluate the feasibility and effectiveness of digital adherence support, among outpatients with newly diagnosed smear positive pulmonary tuberculosis treated in Vietnam. Study design: A two-arm randomised controlled study that will compare digital adherence monitoring and automated reminders with scheduled history review, with a control group receiving standard self-administered therapy. Sample size: 180 patients will be randomized into 2 arms of study Study procedure: In summary, patients with confirmed pulmonary TB and meeting the above criteria will be invited to participate in the study. After giving consent form of agreement, the TB patient will be asked for complete a baseline questionnaire (Q1) and dispensed a digital adherence monitoring box to record daily adherence until the end of their completion therapy or until lost to follow up, transfer out or treatment failure is documented by the NTP staff, according to the NTP's definitions. The participant will be randomised into one of two arms. In arm 1, the patient will receive a wisepill box to record adherence but NOT to provide alerts, they will be followed up by routine procedure regarding to the NTP's guideline. In arm 2, the patient will receive a wisepill box to record adherence with alarm, routine monthly counseling on adherence from health staff and tailored with individual adherence report, and phone call from health staff to remind patients to take pill if they skip 1 dose in the past one week. Adherence will be evaluated based upon the report from electronic drug monitoring box, in addition of monthly remaining-pill count by the health staff. At the end of each month follow up, the patient in two arms will be administered some follow-up questions in the Follow-up Card until their treatment outcome is recorded. When the treatment is end, the patient will be invited to complete a questionnaire (Q2) asking them about the acceptability of the use of these devices, any problem encountered and overall satisfaction with the adherence monitoring method. Outcomes: The primary outcome will be the proportion of patients who miss less than 20% of doses.
Interventions
• Provided an adherence monitoring box to record daily adherence (MERM) and with alarm in designated time to alert patients to the time their dose is due. Wisepill, the monitoring box, makes use of mobile phone and Internet technologies to provide remote medication management. The Wisepill portable medication dispenser has a GSM communication chip at its heart. The dispenser sends an electronic medication event record to a central management system (Wisepill Web Server) whenever medication is ta
• Provided an adherence monitoring box to record daily adherence (MERM) and with alarm in designated time to alert patients to the time their dose is due. Wisepill, the monitoring box, makes use of mobile phone and Internet technologies to provide remote medication management. The Wisepill portable medication dispenser has a GSM communication chip at its heart. The dispenser sends an electronic medication event record to a central management system (Wisepill Web Server) whenever medication is taken. This truly portable device allows active patients to take their medicine with them wherever they go. It weights 125g with the size of 20 x 60 x 120mm and a rechargeable lithium battery which can run up to six months continuously. • Routine monthly counseling on adherence provided by TB doctors and nurses at district tuberculosis unit where patient registered for TB treatment, tailored with individual adherence report of the preceding month. Approximately each counseling session lasts for 15 to 30 minutes, depends on the level of adherence to treatment of the previous months. They will discuss with the patient: - factors contributing to non-adherence - solutions to improve adherence - adverse event management, if required - a plan for meeting in the following month • If the patient skips doses for two days or more, then they will receive intensive adherence support. This includes a phone call from health staff to discuss adherence. The topics are listed as above. If the battery is low, according to the dashboard, they will be asked to come back for a battery change of the device.
Sponsors
Woolcock Institute of Medical Research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patients with newly diagnosed microbiologically confirmed (smear positive and/or culture positive and/or Xpert MTB positive) pulmonary tuberculosis • Taking only standard oral therapy for tuberculosis • Taking treatment as an outpatient • At least four months of treatment remaining • Aged 15 years and above
Exclusion criteria
• Diagnosed with multi-drug resistant TB prior to enrolment • A history of prior treatment for tuberculosis, before the current episode. • Severe mental illness
Outcome results
None listed