HOUSE
Research type
Research Study
Full title
Home Usability Evaluation
IRAS ID
340749
Contact name
Sacha Howell
Contact email
Sponsor organisation
Entia
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
Single arm usability validation and method comparison study.
This study will be used to simulate use of the Entia Liberty System to demonstrate that the intended users can use the System safely and effectively.
This study will recruit up to 100 participants with a diagnosis of solid tumour cancer who are undergoing systemic anti-cancer therapy from tertiary health care centres. Participants will attend two visits, 3-5 weeks apart, at the study site. The visits will take place in an area that has been set up to simulate a home environment.
During Visit 1, participants will be expected to undergo training on how to use the Entia Liberty System and complete their first self-test with guidance from the instructor. Participants will be provided with the Instructions For Use (IFU), short guides, and access to instructional videos between the two visits.
Following the training decay period of 3-5 weeks, participants will attend Visit 2. During this visit, participants will carry out 2 self-tests using the Entia Liberty System, and complete a usability questionnaire. Participants will observed by a researcher, who will complete a usability checklist and error analysis. Participants will also be recorded interacting with the device for purposes of assessing user deviations and hazards. These recordings will capture the participants' interaction with the device to establish that they can perform a test within the accepted deviations limit. Participants will undergo a venous blood draw to obtain full blood count results on a gold-standard laboratory haematology analyser, if the visit does not take place on the same day as routine monitoring. During this visit, the participant will be randomised to having either low, medium or high background noise to simulate potential home disturbances.
Results obtained through this study will not be used for clinical decision making, and the participants’ standard of care will not be affected.
REC name
Wales REC 2
REC reference
24/WA/0079
Date of REC Opinion
11 Apr 2024
REC opinion
Further Information Favourable Opinion