title: ClereMed: Lessons Learned From a Pilot Study of a Mobile Screening Tool to Identify and Support Adults Who Have Difficulty With Medication Labels.
abstract: BACKGROUND
  In order to take medications safely and effectively, individuals need to be able to see, read, and understand the medication labels. However, one-half of medication labels are currently misunderstood, often because of low literacy, low vision, and cognitive impairment. We sought to design a mobile tool termed ClereMed that could rapidly screen for adults who have difficulty reading or understanding their medication labels.
  
  
  OBJECTIVE
  The aim of this study was to build the ClereMed prototype; to determine the usability of the prototype with adults 55 and over; to assess its accuracy for identifying adults with low-functional reading ability, poor ability on a real-life pill-sorting task, and low cognition; and to assess the acceptability of a touchscreen device with older adults with age-related changes to vision and cognition.
  
  
  METHODS
  This pilot study enrolled adults (≥55 years) who were recruited through pharmacies, retirement residences, and a low-vision optometry clinic. ClereMed is a hypertext markup language (HTML)-5 prototype app that simulates medication taking using an iPad, and also provides information on how to improve the accessibility of prescription labels. A paper-based questionnaire included questions on participant demographics, computer literacy, and the Systems Usability Scale (SUS). Cognition was assessed using the Montreal Cognitive Assessment tool, and functional reading ability was measured using the MNRead Acuity Chart. Simulation results were compared with a real-life, medication-taking exercise using prescription vials, tablets, and pillboxes.
  
  
  RESULTS
  The 47 participants had a mean age of 76 (SD 11) years and 60% (28/47) were female. Of the participants, 32% (15/47) did not own a computer or touchscreen device. The mean SUS score was 76/100. ClereMed correctly identified 72% (5/7) of participants with functional reading difficulty, and 63% (5/8) who failed a real-life pill-sorting task, but only 21% (6/28) of participants with cognitive impairment. Participants who owned a computer or touchscreen completed ClereMed in a mean time of 26 (SD 16) seconds, compared with 52 (SD 34) seconds for those who do not own a device (P<.001). Those who had difficulty, struggled with screen glare, button activation, and the "drag and drop" function.
  
  
  CONCLUSIONS
  ClereMed was well accepted by older participants, but it was only moderately accurate for reading ability and not for mild cognitive impairment. Future versions may be most useful as part of a larger medication assessment or as a tool to help family members and caregivers identify individuals with impaired functional reading ability. Future research is needed to improve the sensitivity for measuring cognitive impairment and on the feasibility of implementing a mobile app into pharmacy workflow.
authors.affiliation: School of Pharmacy, University of Waterloo, Waterloo, ON, Canada. kgrindrod@uwaterloo.ca.
authors.forename: Kelly Anne
authors.identifier: http://orcid.org/0000-0003-1135-0391
authors.initials: KA
authors.lastname: Grindrod
authors.forename: Allison
authors.identifier: http://orcid.org/0000-0001-6137-4848
authors.initials: A
authors.lastname: Gates
authors.forename: Lisa
authors.identifier: http://orcid.org/0000-0002-0061-6783
authors.initials: L
authors.lastname: Dolovich
authors.forename: Roderick
authors.identifier: http://orcid.org/0000-0001-9738-1978
authors.initials: R
authors.lastname: Slavcev
authors.forename: Rob
authors.identifier: http://orcid.org/0000-0002-2742-073X
authors.initials: R
authors.lastname: Drimmie
authors.forename: Behzad
authors.identifier: http://orcid.org/0000-0001-8882-7624
authors.initials: B
authors.lastname: Aghaei
authors.forename: Calvin
authors.identifier: http://orcid.org/0000-0001-8474-2025
authors.initials: C
authors.lastname: Poon
authors.forename: Shamrozé
authors.identifier: http://orcid.org/0000-0001-6044-7566
authors.initials: S
authors.lastname: Khan
authors.forename: Susan J
authors.identifier: http://orcid.org/0000-0002-7082-035X
authors.initials: SJ
authors.lastname: Leat
keywords: cognitive impairment; legibility; low vision; medication labels; prescription labelling; usability; visual impairment