Shattuck, D., Haile, L. T., & Simmons, R. G. (2018). Lessons From the Dot Contraceptive Efficacy Study: Analysis of the Use of Agile Development to Improve Recruitment and Enrollment for mHealth Research. JMIR mHealth and uHealth. https://doi.org/10.2196/mhealth.9661
Shattuck D, Haile LT, Simmons RG. Lessons From the Dot Contraceptive Efficacy Study: Analysis of the Use of Agile Development to Improve Recruitment and Enrollment for mHealth Research. JMIR mHealth and uHealth. 2018. doi:10.2196/mhealth.9661
Shattuck, Dominick, et al. "Lessons From the Dot Contraceptive Efficacy Study: Analysis of the Use of Agile Development to Improve Recruitment and Enrollment for mHealth Research." JMIR mHealth and uHealth, 2018.
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Adding self-enrollment raised sign-ups in the Dot fertility app study
In a nonrandomized study of the Dot fertility app, about 7 out of 10 eligible women enrolled once self-enrollment was available, up from about 2 out of 10 earlier. The Georgetown University team changed its recruitment steps three times. It enrolled 719 women, above its goal of 700.
Key Findings
The original phone-only process enrolled 22 of 103 eligible women (21%). Modification 1 enrolled 60 of 267 (22.5%), and modification 2 enrolled 143 of 674 (21.2%).
After modification 3, which added a fully automated enrollment option, 494 of 715 eligible women enrolled (69.1%).
719 women enrolled over a 6-month period: 29.2% (210/719) by phone, 19.9% (143/719) by chat or instant message, and 50.9% (366/719) through the automated process.
Education level differed significantly across the modifications (P<.001). More women reported some college over time, and fewer reported a bachelor's degree.
Age (P=.06) and race or ethnicity (P=.08) did not differ significantly across the modifications.
Interpretation
The report describes one nonrandomized efficacy study of a fertility app. The team changed enrollment steps in sequence for a single cohort, so each stage's results follow the stage before it. Participants were Android users aged 18 to 39 who chose the app to prevent pregnancy. Anecdotally, more than two-thirds of participants traced the app's advertisements to Facebook. The authors note that available systems do not support comparing enrolled women with women who downloaded the app and did not enroll. The study continues to follow participants for 13 menstrual cycles.
RRM Context
Restorative reproductive medicine teaches women to understand their own cycles. Fertility apps offer one route to that knowledge. The authors argue that apps claiming to prevent pregnancy need the same rigorous research as other contraceptive methods. The Dot study follows standard guidelines for contraceptive efficacy studies. It aims for at least 255 women completing 13 cycles of use. The one earlier study of a pregnancy-prevention app kept 3.53% of participants through 13 cycles.
Our editorial summary of this paper, not the article's abstract.
Abstract
Background
Smartphone apps that provide women with information about their daily fertility status during their menstrual cycles can contribute to the contraceptive method mix. However, if these apps claim to help a user prevent pregnancy, they must undergo similar rigorous research required for other contraceptive methods. Georgetown University's Institute for Reproductive Health is conducting a prospective longitudinal efficacy trial on Dot (Dynamic Optimal Timing), an algorithm-based fertility app designed to help women prevent pregnancy.
Objective
The aim of this paper was to highlight decision points during the recruitment-enrollment process and the effect of modifications on enrollment numbers and demographics. Recruiting eligible research participants for a contraceptive efficacy study and enrolling an adequate number to statistically assess the effectiveness of Dot is critical. Recruiting and enrolling participants for the Dot study involved making decisions based on research and analytic data, constant process modification, and close monitoring and evaluation of the effect of these modifications.
Methods
Originally, the only option for women to enroll in the study was to do so over the phone with a study representative. On noticing low enrollment numbers, we examined the 7 steps from the time a woman received the recruitment message until she completed enrollment and made modifications accordingly. In modification 1, we added call-back and voicemail procedures to increase the number of completed calls. Modification 2 involved using a chat and instant message (IM) features to facilitate study enrollment. In modification 3, the process was fully automated to allow participants to enroll in the study without the aid of study representatives.
Results
After these modifications were implemented, 719 women were enrolled in the study over a 6-month period. The majority of participants (494/719, 68.7%) were enrolled during modification 3, in which they had the option to enroll via phone, chat, or the fully automated process. Overall, 29.2% (210/719) of the participants were enrolled via a phone call, 19.9% (143/719) via chat/IM, and 50.9% (366/719) directly through the fully automated process. With respect to the demographic profile of our study sample, we found a significant statistical difference in education level across all modifications (P<.05) but not in age or race or ethnicity (P>.05).
Conclusions
Our findings show that agile and consistent modifications to the recruitment and enrollment process were necessary to yield an appropriate sample size. An automated process resulted in significantly higher enrollment rates than one that required phone interaction with study representatives. Although there were some differences in demographic characteristics of enrollees as the process was modified, in general, our study population is diverse and reflects the overall United States population in terms of race/ethnicity, age, and education. Additional research is proposed to identify how differences in mode of enrollment and demographic characteristics may affect participants' performance in the study.
Trial Registration
ClinicalTrials.gov NCT02833922; http://clinicaltrials.gov/ct2/show/NCT02833922 (Archived by WebCite at http://www.webcitation.org/6yj5FHrBh).
