Drug susceptible tuberculosis
Conditions
Interventions
Elucid Pill Connect system for use in adherence monitoring and informing of personalized drug dosing regimens among tuberculosis patients.
Sponsors
Elucid mHealth
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age>18 2. Patients receiving at least oral isoniazid/rifampicin as part of their treatment for drug susceptible tuberculosis, and deemed non-contagious by the judgement of treating physician 3. Signed informed consent 4. Patients should own an Android phone or Iphone with the required OS versions and be able to operate the mobile phone themselves
Exclusion criteria
Exclusion criteria: 1. Assessed prior to patient enrolment: Contagious patients 2. Criteria assessed after patient enrolment: Subject informs he/she will not be able to participate in the trial 3. Withdrawal of informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of this pilot study is to evaluate the feasibility of using a smart pill bottle (i.e. the Elucid Pill Connect System) in terms of patient and healthcare provider satisfaction (Systems Usability Scale, SUS). Exploratory clinical outcomes include medication adherence as measured by self-report (Medication Adherence Rating Scale (MARS) and SEAMS for self-efficacy)), pill bottle data and saliva levels. | — |
Secondary
| Measure | Time frame |
|---|---|
| Additionally, in patients receiving dosages through the smart pill bottle, between 10-14 days rifampicin concentration at a single time-point will be measured in saliva at two hours post dose to confirm that pills were swallowed by the patients after being dispensed by the smart pill bottle. | — |
Contacts
Public ContactDr. Samiksha Ghimire
University Medical Center Groningen
Outcome results
None listed