ArticleJournal of medical Internet research2024
Methodological Challenges in Randomized Controlled Trials of mHealth Interventions: Cross-Sectional Survey Study and Consensus-Based Recommendations.
Article in Journal of medical Internet research, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
6 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Effectiveness of mHealth Interventions Aimed at Promoting Physical Activity and Reducing Sedentary Behavior on Work-Related Outcomes Among Workers: Systematic Review.Journal of medical Internet research · 2026Pooled it
- Nurse-Led Digital Intervention for Sodium Restriction in Chronic Kidney Disease: Mixed Methods Implementation Study.JMIR nursing · 2026Trial
- Digital solutions, real-world challenges: lessons from mHealth trials in oncology.Frontiers in digital health · 2025Trial
- Prevalence and Determinants of Uncontrolled Hypertension Among Treated Adults in a Rural Primary Health Care Facility in South Africa: A Cross-Sectional Study.Epidemiologia (Basel, Switzerland) · 2026Article
- Increasing Truck Drivers' Compliance, Retention, and Long-Term Engagement with e-Health & Mobile Applications: A PRISMA Systematic Review.Healthcare (Basel, Switzerland) · 2026Review
- Exploring the Utilisation of Internationally Qualified Nurses' Specialty Skills: Analysis of Recruiting Managers' View Points.Nursing open · 2025Article
Corrections and comments
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Authors and funding
15 authors.
Funding
Abstract
backgroundMobile health (mHealth) refers to using mobile communication devices such as smartphones to support health, health care, and public health. mHealth interventions have their own nature and characteristics that distinguish them from traditional health care interventions, including drug interventions. Thus, randomized controlled trials (RCTs) of mHealth interventions present specific methodological challenges. Identifying and overcoming those challenges is essential to determine whether mHealth interventions improve health outcomes.
objectiveWe aimed to identify specific methodological challenges in RCTs testing mHealth interventions' effects and develop consensus-based recommendations to address selected challenges.
methodsA 2-phase participatory research project was conducted. First, we sent a web-based survey to authors of mHealth RCTs. Survey respondents rated on a 5-point scale how challenging they found 21 methodological aspects in mHealth RCTs compared to non-mHealth RCTs. Nonsystematic searches until June 2022 informed the selection of the methodological challenges listed in the survey. Second, a subset of survey respondents participated in an online workshop to discuss recommendations to address selected methodological aspects identified in the survey. Finally, consensus-based recommendations were developed based on the workshop discussion and email interaction.
resultsWe contacted 1535 authors of mHealth intervention RCTs, of whom 80 (5.21%) completed the survey. Most respondents (74/80, 92%) identified at least one methodological aspect as more or much more challenging in mHealth RCTs. The aspects most frequently reported as more or much more challenging were those related to mHealth intervention integrity, that is, the degree to which the study intervention was implemented as intended, in particular managing low adherence to the mHealth intervention (43/77, 56%), defining adherence (39/79, 49%), measuring adherence (33/78, 42%), and determining which mHealth intervention components are used or received by the participant (31/75, 41%). Other challenges were also frequent, such as analyzing passive data (eg, data collected from smartphone sensors; 24/58, 41%) and verifying the participants' identity during recruitment (28/68, 41%). In total, 11 survey respondents participated in the subsequent workshop (n=8, 73% had been involved in at least 2 mHealth RCTs). We developed 17 consensus-based recommendations related to the following four categories: (1) how to measure adherence to the mHealth intervention (7 recommendations), (2) defining adequate adherence (2 recommendations), (3) dealing with low adherence rates (3 recommendations), and (4) addressing mHealth intervention components (5 recommendations).
conclusionsRCTs of mHealth interventions have specific methodological challenges compared to those of non-mHealth interventions, particularly those related to intervention integrity. Following our recommendations for addressing these challenges can lead to more reliable assessments of the effects of mHealth interventions on health outcomes.
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