An intervention fidelity framework for technology-based behavioral interventions.

Background: Despite the proliferation of health technologies, descriptions of the unique considerations and practical guidance for evaluating the intervention fidelity of technology-based behavioral interventions are lacking.

Objectives: The aims of this study were to (a) discuss how technology-based behavioral interventions challenge conventions about how intervention fidelity is conceptualized and evaluated, (b) propose an intervention fidelity framework that may be more appropriate for technology-based behavioral interventions, and (c) present a plan for operationalizing each concept in the framework using the intervention fidelity monitoring plan for Pocket PATH (Personal Assistant for Tracking Health), a mobile health technology designed to promote self-care behaviors after lung transplantation, as an exemplar.

Method: The literature related to intervention fidelity and technology acceptance was used to identify the issues that are unique to the fidelity of technology-based behavioral interventions and thus important to include in a proposed intervention fidelity framework.

Data safety and monitoring for research involving remote health monitoring.

Investigators conducting research involving human subjects are obligated to safeguard the wellbeing of the study participants. Other than requiring investigators to establish procedures for ongoing monitoring and reporting of adverse events, federal regulations do not dictate how human subject safety should be ensured. A variety of data safety monitoring (DSM) procedures may be acceptable depending on the nature, size, and complexity of the study.