The EASY Label Study
Research type
Research Study
Full title
Examining the assumptions, accuracy and acceptance of an electronic monitoring device for adherence to eye drops: the EASY label study
IRAS ID
272159
Contact name
James Morgan
Contact email
Sponsor organisation
Cardiff University
ISRCTN Number
ISRCTN76140296
Duration of Study in the UK
0 years, 5 months, 31 days
Research summary
Glaucoma treatment is only effective if patients instil eye drops on time daily. However, research has demonstrated that many patients find this problematic such that poor adherence places them at risk of sight loss. One of the difficulties for nurses, other healthcare workers (HCWs), and researchers is the lack of a ‘gold standard’ to quantify adherence. Clinically, the lack of an objective measure presents a nursing challenge in directing resources to support patients’ and leads to difficulties with personalising the provision of educational interventions.
To address this, we have developed a prototype tool to measure adherence called the EASY label which records when patients squeeze an eye drop bottle. This new tool is a significant advance clinically and for research because it measures the time point at which the drop is instilled on the assumption that this enters the eye (acknowledged as the best possible approximation of adherence).
The present study will have patients and healthcare workers perform usability testing on the EASY label prototype before it enters mass production. We will ask participants to instil eye drops into a plastic model head so as to measure: 1) whether the label functions reliably; 2) if it registers each eye drop instilled accurately in that there are no over or under registrations as each drop is instilled and if the users use the label as instructed; 3) whether patients with different diagnoses respond similarly and if it affects normal adherence behaviour. A key part of the study will explore user acceptance by interviewing patients and HCWs about the usefulness, practicalities and ethics of the label. By involving patients and HCWs at this early stage, we will ensure the relevance and ownership of the label in the real world making it a viable option to support patient-centred research into adherence.
REC name
East of Scotland Research Ethics Service REC 1
REC reference
20/ES/0041
Date of REC Opinion
30 Mar 2020
REC opinion
Further Information Favourable Opinion