No registrations found.
ID
Source
Brief title
Health condition
None
Sponsors and support
Intervention
Outcome measures
Primary outcome
Usability of the MEMS EDP, measured by the System Usability Scale (SUS)
Secondary outcome
• Comparison of the MEMS EDP data with manual pill count
• Comparison of the MEMS EDP data with self-reported adherence,
• Technical assessment
• Qualitative evaluation
Background summary
A novel medication event monitoring system (MEMS®) has been developed in the form of a smart blister package (Electronic DosePak, EPD®). This study will aims to investigate usability of the MEMS EDP® smart blister system for use in trials at the University Medical Center Groningen and beyond.
We propose a pragmatic trial examining the acceptance and technical robustness of the MEMS EDP system. We will include 20 healthy volunteers (English speaking) with diverse age/sex/education.
The key objectives of this study:
• Perform analysis and validation of the MEMS EDP’s robustness, accuracy and patient acceptance within a clinical study
• Initial investigation of benefits to health professionals and subjects when the MEMS EDP is used to support, measure, and monitor dispensing of medicines
Study objective
In order for the MEMS EPD 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.
Study design
Subjects will have one digital meeting and two site visits:
• Prior to visit 1, all subjects will attend a (digital) general kick-off meeting with information on the study and have training on how to use the EDP.
• At Visit 1, they will receive the EPD in person (or by mail post if applicable).
• At Visit 2, they will return the blisters with a short one to one interview and are reminded to complete the online questionnaires (in English).
Intervention
All participants receive four MEMS EDP's containing 14 placebo tablets per blister. The placebo tablets are taken out twice daily (not intended to be ingested). The follow-up period is four weeks.
Inclusion criteria
Subjects will be eligible for the trial if all the following criteria are met:
• age >18 years
• provide informed consent
Exclusion criteria
• Subject informs he/she will not be able to participate in the trial
• 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 | NL9535 |
| Other | METc UMCG : 2021/363 |