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

Daniel Pach,Jiani Wang,Alizé A Rogge,Claudia M Witt

doi:10.2196/20630

Abstract

BackgroundClinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions.ObjectiveWe aimed to establish practical lessons from the experience of our working group, which might accelerate the development of future mHealth interventions and their evaluation by randomized controlled trials (RCTs).MethodsThis paper is based on group and expert discussions, and focuses on the researchers’ perspectives after four RCTs on mHealth interventions for chronic pain.ResultsThe following five lessons are presented, which are based on practical application, increase of speed, and sustainability: (1) explore stakeholder opinions, (2) develop the mHealth app and trial simultaneously, (3) minimize complexity, (4) manage necessary resources, and (5) apply behavior change techniques.ConclusionsThe five lessons developed may lead toward an agile research environment. Agility might be the key factor in the development and research process of a potentially sustainable and evidence-based mHealth intervention.

Highlights

Forecasts suggest that digital health might disrupt health care [1]
DVG aims at achieving better coverage of patients through digitization and innovation by implementing the entitlement of insured individuals to digital health apps and allowing physicians to prescribe apps such as mobile Health interventions, which are reimbursed as medical interventions by the statutory health insurances
We provide five recommendations for future app developers based on our expertise gained from four mobile health (mHealth) randomized controlled trials (RCTs) for the pain conditions dysmenorrhea [12,13,14], and back pain and neck pain [15] in a clear concise way

Summary

Introduction

Forecasts suggest that digital health might disrupt health care [1]. the increasing importance of mHealth technology such as tracing apps against COVID-19 has highlighted that such disruption is already happening. The. DVG aims at achieving better coverage of patients through digitization and innovation by implementing the entitlement of insured individuals to digital health apps and allowing physicians to prescribe apps such as mobile Health (mHealth) interventions, which are reimbursed as medical interventions by the statutory health insurances. The DVG aims to expand the telematics structure in health care, entitle patients to digital apps, promote the development of digital https://mhealth.jmir.org/2021/2/e20630 XSLFO RenderX. 1 (page number not for citation purposes) innovations, and financially support developers in the field in cooperation with the statutory health insurance companies [2,3]. Given these new opportunities for the integration of mHealth interventions in Germany, the quality of their development is of major importance. Clinical research on mobile health (mHealth) interventions is too slow in comparison to the rapid speed of technological advances, thereby impeding sustainable research and evidence-based implementation of mHealth interventions

Methods

Results

Conclusion