No registrations found.
Source
Brief title
Health condition
Drug susceptible tuberculosis
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Tuberculosis (TB) remains the leading cause of death by infectious disease; but it is both preventable and curable. Standard TB treatment duration is minimum 6 months and faces challenges with patients having difficulties adhering to- and completing- the appropriate treatment regimens. The smart pill bottle (Elucid Pill Connect system) has been developed with the aim of providing novel insights into non-adherence and supporting patients to better manage their medicines. Of note, in a previous study performed at the UMCG, we observed high user satisfaction with this smart pill bottle. Together, it is hoped these can be used to improve adherence. Therefore, in this observational pilot study we would like to further investigate the utility of the smart pill bottle for use in medicine dispensing among TB patients receiving treatment at University Medical Center Groningen, TB Center. This will be done by assessing patient and healthcare provider satisfaction, and exploring medication adherence as measured by self-report (Medication Adherence Rating Scale, MARS and SEAMS), pill bottle dispense data and measuring salivary concentrations of rifampicin.
From the results of this study, we expect to gain insight into the suitability of the smart pill bottle for use in adherence monitoring and informing of personalized drug dosing regimens among tuberculosis patients.
Study objective
Elucid Pill Connect system can be used to improve adherence and self-management in patients with tuberculosis.
Study design
T=0; T= 2 weeks
Intervention
Elucid Pill Connect system for use in adherence monitoring and informing of personalized drug dosing regimens among tuberculosis patients.
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
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
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL9006 |
Other | METC UMCG : METc 2020/483 |