Pennell, P; French, J; Harden, C L; Bartfeld, E; Davis, A R; Llewellyn, N G; Staley, B A; Lau, C; Keenan, H A
"Evaluation of a mobile application tool in the wepod study" [Meeting Abstract]
Epilepsy currents 2012 2012; 12(1):-
- Rationale: The purpose of this study is to evaluate the use of an electronic diary system with a mobile application tool in an epilepsy trial. Clinical trials in epilepsy can be compromised by inaccurate reporting of seizures and other clinical events. Paper diaries, which are the standard, do not assess whether data was entered in a timely fashion. Electronic diaries (particularly coupled with mobile devices) may not only facilitate reporting by subjects, but also enable monitoring of the interval from occurrence of event to entry time as a marker of validity and accuracy, and allow real-time monitoring of adherence with study procedures. The WEPOD (Women with Epilepsy: Pregnancy Outcomes and Deliveries) study is a 3-site prospective, observational study evaluating fertility, hormones, AED concentrations, and seizure frequency as women with epilepsy (WWE) transition from preconception planning through pregnancy and delivery. We assessed the ability of subjects to use electronic data entry and the timeliness of data entry. Methods: Women with epilepsy and controls, ages 18-40 years, seeking pregnancy are enrolled within 6 months of stopping birth control. A customized iPod Touch Application (the WEPOD App) was developed for daily tracking of primary clinical data. The WEPOD App is connected to a web-based program utilizing the infrastructure of "My Epilepsy Diary" by epilepsy.com. All subjects were given an iPod Touch 4, but they could also elect to use the web-based program or a paper diary. All subjects were asked to track menstrual flow and sexual activity daily (fertility diary). WWE also tracked AED adherence and seizure occurrence. The WEPOD App includes an alarmed daily reminder asking the subject if she tracked today. Results: At this interim analysis, 16 WWE and 21 controls were enrolled and provided diary data for 1402 days and 1186 days, respectively. All subjects used the WEPOD app and/or the web; no subjects chose paper diaries. No significant differences were found between the WWE and controls for age, race, ethnicity, education, and employment (Table 1) (p>0.05). Average days of data entry was 86.6 +/-60.4 (range 2- 189) for WWE, and 57.2 +/-50.4 (range 1-180) for controls. On average the completion of the fertility diary was 100% +0.3 for WWE and 100% +0.3 for controls (minimum 48% and 65%, respectively). Time stamps for 89 seizures revealed that 83.2% were entered <24 hours of reported seizure occurrence. Mean time to report was 14.5 +/-23.7 hours. Conclusions: Use of a customized mobile App for daily tracking of clinical data has been an effective tool in the WEPOD trial. Use of an iPod Touch could serve as a positive recruiting tool in the young adult population targeted for this study, but did not cause an imbalance between the two groups. Time to seizure entry was excellent. Additional benefits include a daily reminder alarm, ability to monitor protocol compliance, and immediate information to schedule study visits, especially if timed to an event such as menstrual flow. Future directions include evaluation of this tool across a variety of populations, trial designs, and diseases
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