Article type
Abstract
"Background: Mobile health (mHealth) uses mobile technology, such as smartphones, to support and optimize healthcare. mHealth currently plays an essential role in healthcare. Randomised controlled clinical trials (RCTs) are vital for evaluating health interventions and ensuring that resources are used effectively to improve healthcare outcomes. However, mHealth RCTs may present specific methodological challenges.
Objectives: 1) Identify specific methodological challenges in RCTs of mHealth interventions; 2) Prioritise and discuss a selected group of challenges; and 3) Provide recommendations for overcoming prioritised challenges.
Methods: Three-phase NIH-funded project (Cochrane Complementary Medicine Field: Resource for Research (2R24AT001293)). O1) Online survey to collect methodological challenges specific to RCTs of mHealth interventions. O2) Online workshop with experts to prioritise and discuss challenges. O3) Development of recommendations via consensus.
Results: 80 authors of mHealth RCTs participated in the survey. The methodological aspects most frequently reported as more or much more challenging were those concerning mHealth intervention integrity (the degree to which the study intervention was implemented as intended), particularly managing low intervention adherence (86.0%) and defining adherence (49.4%). Other challenges identified were analysing passive data (e.g., data collected from smartphone sensors) (41.4%) and verifying the participants' identity during recruitment (41.2%). Eleven experts participated in the subsequent consensus workshop and developed seventeen recommendations for overcoming methodological challenges in mHealth RCTs, most concerning mHealth intervention integrity. One important recommendation is that adherence assessment in mHealth trials should diverge from the approaches commonly employed in drug efficacy trials. Specifically, when evaluating mHealth intervention adherence, it is crucial to account for factors such as internet access requirements and the interoperability of the mHealth app.
Conclusions: RCTs assessing mHealth interventions encounter distinct methodological challenges. This study has formulated recommendations to address the most salient methodological hurdles faced in mHealth RCTs, with a significant focus on the integrity of mHealth interventions.
Patient or healthcare consumer involvement: None."
Objectives: 1) Identify specific methodological challenges in RCTs of mHealth interventions; 2) Prioritise and discuss a selected group of challenges; and 3) Provide recommendations for overcoming prioritised challenges.
Methods: Three-phase NIH-funded project (Cochrane Complementary Medicine Field: Resource for Research (2R24AT001293)). O1) Online survey to collect methodological challenges specific to RCTs of mHealth interventions. O2) Online workshop with experts to prioritise and discuss challenges. O3) Development of recommendations via consensus.
Results: 80 authors of mHealth RCTs participated in the survey. The methodological aspects most frequently reported as more or much more challenging were those concerning mHealth intervention integrity (the degree to which the study intervention was implemented as intended), particularly managing low intervention adherence (86.0%) and defining adherence (49.4%). Other challenges identified were analysing passive data (e.g., data collected from smartphone sensors) (41.4%) and verifying the participants' identity during recruitment (41.2%). Eleven experts participated in the subsequent consensus workshop and developed seventeen recommendations for overcoming methodological challenges in mHealth RCTs, most concerning mHealth intervention integrity. One important recommendation is that adherence assessment in mHealth trials should diverge from the approaches commonly employed in drug efficacy trials. Specifically, when evaluating mHealth intervention adherence, it is crucial to account for factors such as internet access requirements and the interoperability of the mHealth app.
Conclusions: RCTs assessing mHealth interventions encounter distinct methodological challenges. This study has formulated recommendations to address the most salient methodological hurdles faced in mHealth RCTs, with a significant focus on the integrity of mHealth interventions.
Patient or healthcare consumer involvement: None."