Charité - Universitätsmedizin Berlin, corporate member of Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Institute for Social Medicine, Epidemiology and Health Economics, Berlin, Germany.
NICM Health Research Institute, Western Sydney University, Sydney, Australia.
JMIR Mhealth Uhealth. 2020 Feb 11;8(2):e14661. doi: 10.2196/14661.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT03432611; https://clinicaltrials.gov/ct2/show/NCT03432611 (Archived by WebCite at http://www.webcitation.org/75LLAcnCQ).
原发性痛经是生育年龄妇女的常见病症。本团队之前进行的一项基于应用程序的研究表明，由医疗保健专业人员引入的支持自我穴位按压的智能手机应用程序可以减轻月经疼痛。
本研究旨在评估在自我保健环境中，针对 18 至 34 岁原发性痛经的女性，特定的智能手机应用程序是否可以有效减轻月经疼痛。一组女性可以访问完整功能的研究应用程序，并且将与可以访问较少应用程序功能的 2 个对照组进行比较。在这里，我们报告试验设计、应用程序开发、用户访问和参与情况。
根据之前基于应用程序的研究的实际意义，我们对研究应用程序进行了修订和重新设计，并包含了 ResearchKit（Apple Inc）框架。行为改变技术（BCTs）被应用于应用程序中，并通过专家评分进行验证。通过评估随时间推移的招募进度来估计用户访问量。评估用户演变和基线调查应答率，以评估用户参与度。
为了进行 3 臂随机对照试验，开发了研究应用程序，需要一个多学科团队。该应用程序可供目标人群免费通过 Apple App Store 访问。在德国，在 9 个月内，该应用程序被下载了 1458 次，并且无需外部广告就通过它招募了 328 名研究参与者。基于应用程序的基线问题共有 98.27%（5157/5248）得到回答。应用程序中使用的 BCTs 的正确分类需要心理专业知识。
开展创新性的应用程序研究需要多学科的努力。通过在 App Store 上进行招募，可以轻松访问和参与此类应用程序。未来的研究需要调查用户参与度的决定因素、最佳 BCT 应用以及应用程序使用的潜在临床和自我保健场景。
ClinicalTrials.gov NCT03432611；https://clinicaltrials.gov/ct2/show/NCT03432611（由 WebCite 存档，http://www.webcitation.org/75LLAcnCQ）。
