International ResearchKit App for Women with Menstrual Pain (Development, Access, and Engagement): Pragmatic Randomized Control Trial

Abstract

Background Primary dysmenorrhea is a common condition in women of reproductive age. A previous app-based study undertaken by our group demonstrated that a smartphone app supporting self-acupressure introduced by a health care professional can reduce menstrual pain. Objective This study aims to evaluate whether a specific smartphone app is effective in reducing menstrual pain in 18- to 34-year-old women with primary dysmenorrhea in a self-care setting. One group of women has access to the full-featured study app and will be compared with 2 control groups who have access to fewer app features. Here, we report the trial design, app development, user access, and engagement. Methods On the basis of the practical implications of the previous app-based study, we revised and reengineered the study app and included the ResearchKit (Apple Inc) framework. Behavior change techniques (BCTs) were implemented in the app and validated by expert ratings. User access was estimated by assessing recruitment progress over time. User evolution and baseline survey respondent rate were assessed to evaluate user engagement. Results The development of the study app for a 3-armed randomized controlled trial required a multidisciplinary team. The app is accessible for the target population free of charge via the Apple App Store. In Germany, within 9 months, the app was downloaded 1458 times and 328 study participants were recruited using it without external advertising. A total of 98.27% (5157/5248) of the app-based baseline questions were answered. The correct classification of BCTs used in the app required psychological expertise. Conclusions Conducting an innovative app study requires multidisciplinary effort. Easy access and engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of user engagement, optimal BCT application, and potential clinical and self-care scenarios for app use. Trial Registration ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ).

Five Lessons Learned From Randomized Controlled Trials on Mobile Health Interventions: Consensus Procedure on Practical Recommendations for Sustainable Research

“…Example: During development of the Luna. app [ 14 ], we decided to use the data collected for outcome measurement, the NRS for pain ranging from 0 (no pain) to 10 (most intense pain imaginable), and number of activities against period pain as an additional feature for the app dashboard. In this way, the study participants could directly benefit from the data collected for the trial.…”

“…Example: The development of our Luna. app [ 14 ] was based on previous app and trial experiences of the AKUD trial. During the preparation of the new trial, the effort for ethical approvals in the participating countries, requiring staff and time, was underestimated.…”

“…Besides scalability and efficiency, behavior change is a key component of mHealth [ 21 ]. Michie et al [ 23 ] defined the smallest, observable, replicable intervention component with the potential to bring about change in behavior as a BCT [ 14 , 24 ]. BCTs could also be defined as “a systematic procedure included as an active component of an intervention designed to change behavior” [ 23 ].…”

“…The evidence-based app Luna. [ 14 ] (pronounced “Luna period”; trial registration: ClinicalTrials.gov NCT03432611) aims to reduce menstrual pain in women with primary dysmenorrhea (aged 18 to 34 years) by providing different self-care strategies such as self-applied acupressure, exercise, and yoga. In this randomized pragmatic trial, one group of women had access to a full-featured study app consisting of a combination of acupressure and additional self-care features, while the two control groups had either access to acupressure or self-care features only.…”

“…The app-based mHealth intervention AKUD [ 13 ] was the precursor study to Luna. [ 14 ], which aimed to investigate the effectiveness of acupressure. In this two-armed randomized pragmatic trial, 221 women aged 18 to 34 years with cramping pain during their menstruation were included and randomized either to the acupressure or usual care group.…”