Accepted for/Published in: JMIR mHealth and uHealth
Date Submitted: Jun 1, 2019
Open Peer Review Period: Jun 4, 2019 - Jul 30, 2019
Date Accepted: Nov 12, 2019
Date Submitted to PubMed: Feb 14, 2020
(closed for review but you can still tweet)
An international ResearchKit app-based pragmatic randomized control trial for women with menstrual pain (primary dysmenorrhea): development, access and engagement
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 healthcare professional can reduce menstrual pain.
Objective:
The objective of this study is 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 two control groups who have access to fewer app features. Here, we report the trial design, app development, user access and participant engagement.
Methods:
Based on the practical implications of the previous app-based study, we revised and re-engineered the study app and included the Apple ResearchKit 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 three-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 1,458 times and 328 participants were recruited using it without external advertising. A total of 98% 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 participant engagement with such an app can be achieved by recruitment via the App Store. Future research is needed to investigate the determinants of participant engagement, optimal BCT application, and potential clinical and self-care scenarios for app use. Clinical Trial: ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ)
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Copyright
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