SUBJECT RECOMMENDATIONS FOR IMPROVING THEIR COMPLIANCE IN COMPLETING ELECTRONIC DIARIES IN DEPRESSION CLINICAL TRIALS
Author(s)
Khurana L1, Gary ST1, Otero AV1, Evans C2, Hall C1, Dallabrida SM1
1ERT, Boston, MA, USA, 2Endpoint Outcomes, Boston, MA, USA
OBJECTIVES: Clinical trials for depression are increasingly using electronic methods to collect patient-reported outcomes (ePRO). The purpose of this study was to determine patient preference for design features to optimize compliance for depression subjects completing daily ePRO diaries. METHODS: 107 subjects with depression were surveyed in the US about their preferences for improving their ePRO compliance and engagement in the trial. RESULTS: Subjects were 23 to 79 years old and 45% female. 56% reported that they would like to see a “thank you” screen at the end of each questionnaire. 39% thought it would be helpful or necessary to regularly receive a graph to track and monitor their symptoms. 83% preferred to see their progress as they completed a questionnaire. 67% of subjects said they would like the first screen of the questionnaire on the device, summarizing questionnaire length/estimated completion time. Subjects were asked if being informed by the device that their compliance was below expectations would motivate them to complete a daily questionnaire. The majority of subjects (64-74%) indicated that this information would motivate them, 18-27% indicated this would have no impact on their motivation, and 8-9% indicated such messaging would be discouraging. When the compliance message was enhanced with a graphic of a sad face, 47% indicated this would motivate them to complete the daily questionnaire, 30% indicated it would have no impact on their motivation, and 23% indicated it would be discouraging. CONCLUSIONS: Subjects with depression reported that they would be motivated by seeing a narrative message communicating their compliance in completing a daily questionnaire, and preferred a diary screen summarizing questionnaire length/completion time, tracking their progress through a questionnaire, and “thank you” messages upon questionnaire completion. Investigators and trial sponsors should consider these preferences when designing elements for use with ePRO assessments in clinical trials.
Conference/Value in Health Info
2016-10, ISPOR Europe 2016, Vienna, Austria
Value in Health, Vol. 19, No. 7 (November 2016)
Code
PMH31
Topic
Patient-Centered Research
Topic Subcategory
Adherence, Persistence, & Compliance, Patient-reported Outcomes & Quality of Life Outcomes, Stated Preference & Patient Satisfaction
Disease
Mental Health