Methodological Challenges in Randomized Controlled Trials of mHealth Interventions: Cross-Sectional Survey Study and Consensus-Based Recommendations
2024

Challenges in mHealth Trials and Recommendations

Sample size: 80 publication 10 minutes Evidence: moderate

Author Information

Author(s): Cahill Naomi, Guo Yan, Liu Danlu, Lopez-Alcalde Jesus MPH, MD, Wieland L Susan MPH, PhD, Yan Yuqian PhD, Barth Jürgen PhD, Khami Mohammad Reza DDS, PhD, Shivalli Siddharudha MD, Lokker Cynthia MSc, PhD, Rai Harleen Kaur PhD, Macharia Paul MSc, PhD, Yun Sergi MD, Lang Elvira MD, PhD, Bwanika Naggirinya Agnes MBChB, MSc, Mmed, Campos-Asensio Concepción BPharm, MLiS, Ahmadian Leila PhD, Witt Claudia M MBA, MD

Primary Institution: Institute for Complementary and Integrative Medicine University Hospital Zurich

Hypothesis

What are the specific methodological challenges in randomized controlled trials (RCTs) testing mHealth interventions, and how can they be addressed?

Conclusion

RCTs of mHealth interventions face unique methodological challenges, particularly regarding intervention integrity, and following our recommendations can enhance the reliability of their assessments.

Supporting Evidence

  • 80 authors of mHealth RCTs completed the survey, identifying key methodological challenges.
  • 74 out of 80 respondents (92%) reported at least one aspect as more challenging in mHealth RCTs.
  • The study developed 17 consensus-based recommendations to address identified challenges.

Takeaway

This study looked at the problems researchers face when testing health apps and suggested ways to make those tests better.

Methodology

A two-phase participatory research project involving a web-based survey and an online workshop to develop consensus-based recommendations.

Potential Biases

Potential bias due to the low response rate and the specific interest of participants in mHealth RCTs.

Limitations

The low response rate may limit the representativeness of the findings, and the study did not account for differences between various types of mHealth interventions.

Participant Demographics

Participants included 80 authors of mHealth RCTs with diverse academic backgrounds, primarily in medicine, psychology, and epidemiology.

Digital Object Identifier (DOI)

10.2196/53187

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