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Methodological Challenges in Randomized Controlled Trials of mHealth Interventions: Cross-Sectional Survey Study and

Jesus Lopez-Alcalde^1,2,3, L Susan Wieland^1,4, Yuqian Yan¹

¹Institute for Complementary and Integrative Medicine, University Hospital Zurich, Zurich, Switzerland.

Journal of Medical Internet Research

|December 19, 2024

Summary

Randomized controlled trials for mobile health interventions face unique challenges, especially regarding intervention integrity and adherence. Addressing these issues with consensus-based recommendations can improve the reliability of mHealth trial results.

Keywords:

adherence consensus digital health eHealth intervention integrity mHealth mobile health mobile phone randomized controlled trial recommendations survey

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Area of Science:

Digital Health
Clinical Trials
Health Services Research

Background:

Mobile health (mHealth) utilizes mobile devices for health support, distinct from traditional interventions.
Randomized controlled trials (RCTs) for mHealth interventions present unique methodological hurdles.
Overcoming these challenges is crucial for validating mHealth's impact on health outcomes.

Purpose of the Study:

Identify specific methodological challenges in mHealth RCTs.
Develop consensus-based recommendations to address these challenges.
Enhance the rigor and reliability of mHealth intervention research.

Main Methods:

A two-phase participatory research approach was employed.
Web-based surveys assessed challenges faced by mHealth RCT authors.
An online workshop and email interactions facilitated consensus on recommendations.

Main Results:

Most mHealth RCT authors reported significant methodological challenges.
Key challenges included mHealth intervention integrity, adherence measurement, and data analysis.
Seventeen consensus-based recommendations were developed across four categories: adherence measurement, definition, low adherence rates, and intervention components.

Conclusions:

mHealth RCTs exhibit distinct methodological challenges compared to non-mHealth trials, particularly concerning intervention integrity.
Implementing the developed recommendations can lead to more dependable assessments of mHealth intervention effectiveness.
This research provides practical guidance for improving mHealth trial design and execution.