JMIR Publications

ABSTRACT

Background:

Mobile Health (mHealth) refers to using mobile communication devices, such as smartphones, to support health, healthcare, and public health. mHealth interventions have their own nature and characteristics that distinguish them from traditional healthcare 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 if mHealth interventions improve health outcomes.

Objective:

We aimed to identify specific methodological challenges in randomized controlled trials (RCTs) testing mHealth interventions' effects and develop consensus-based recommendations to address selected challenges.

Methods:

A two-phase participatory research project was performed. First, we sent an online survey to authors of mHealth RCTs. Survey respondents rated on a five-point scale how challenging they found 21 methodological aspects in mHealth RCTs compared to non-mHealth RCTs. Non-systematic 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.

Results:

We contacted 1,535 authors of mHealth intervention RCTs, of whom 80 (5.2%) completed the survey. All the respondents identified at least one methodological aspect as more challenging in mHealth RCTs. The aspects most frequently reported as more or much more challenging were those related to the mHealth intervention integrity, that is, the degree to which the study intervention was implemented as intended. Particularly managing low adherence to the mHealth intervention (86.0%), defining adherence to the mHealth intervention (49.4%), measuring adherence to the mHealth intervention (42.3%), and determining which mHealth intervention components are used/received by the participant (41.3%). Other challenges were also frequent, such as analyzing passive data (e.g., data collected from smartphone sensors) (41.4%) and verifying the participants' identity during recruitment (41.2%). Eleven survey respondents participated in the subsequent workshop (eight had been involved in at least two mHealth RCTs). We developed seventeen consensus-based recommendations to address issues related to mHealth intervention integrity.

Conclusions:

RCTs of mHealth interventions have specific methodological challenges compared to non-mHealth interventions, particularly those related to the intervention integrity. Following our recommendations for addressing these challenges can lead to more reliable assessments of the effects of mHealth interventions on health outcomes. Clinical Trial: Not applicable