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ID
Source
Brief title
Health condition
Not applicable
Sponsors and support
Intervention
Outcome measures
Primary outcome
Percentage of pills dispensed according to intended dosing schedule
Secondary outcome
User acceptance (measured with the System Usability Scale and a self-designed questionnaire), investigator acceptance, technical validation (correct logging of dispense data, timing, battery life, sending of reminders, locking and temperature) and comparison with self-reported adherence according to the MARS questionnaire
Background summary
The 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. Improving adherence and increasing the accuracy of adherence data may also affect health outcomes and decrease health care utilisation and costs. We propose a pragmatic trial examining the patient acceptance and technical robustness of the ELucid Pill Connect system. In order for it to be used with patients taking medicines, we intend to show that the system is simple for patients to use, collects accurate data, performs as intended for the life of a trial and supports patients to better manage their medicines and supports medication adherence.
Study objective
The Elucid Pill Connect system dispenses all doses correctly and sends accurate data to the monitoring server that represents the subject’s non-adherence whilst enforcing the dose schedule.
Study design
T=0 and T= 2 weeks
Intervention
Provision of the Elucid Pill Connect System
Inclusion criteria
(1) age >18 years, (2) own an Android or Iphone phone with the required OS versions, (3) are able to operate the mobile phone themselves and (4) provide informed consent.
Exclusion criteria
None
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 | NL7835 |
| Other | METC UMCG : METc 2019/332 |