Background: The design and conduct of research to develop, test, and evaluate complex health care interventions is challenging. Although the existing literature describes key challenges associated with the design and conduct of definitive (evaluation) trials, there is a lack of information concerning specific challenges associated with the intervention development phase and setup of feasibility studies. In particular, the literature is scarce concerning the challenges associated with conducting digital health care research, such as research on internet-administered interventions and research using digital features to support the execution of study procedures (eg, recruitment, consent, retention, and data collection and management). This study is conducted in the context of the intervention development and feasibility study setup phases of an internet-administered, guided, low-intensity cognitive behavioral therapy-based intervention for parents of children previously treated for cancer.
Objective: The aim of this study is to explore the challenges experienced during the development phase of the internet-administered intervention and digital features to support the execution of the study procedures and a feasibility study setup.
Methods: To explore the key challenges experienced, we conducted a document analysis of written records from all study meetings held by the research team (meeting minutes) between June 7, 2018, and January 10, 2020, guided by a thematic analysis approach. Furthermore, discussion groups with members of the research team were held to develop a more detailed understanding of the key challenges experienced. Methods and results are reported in accordance with the relevant items from the Standards for Reporting Qualitative Research checklist.
Results: Six main themes were identified: decision-making and communication, expertise, external constraints, flexibility, planning and scheduling, and technical constraints.
Conclusions: Significant challenges were experienced during the intervention development and setup phases of the feasibility study. Implications are discussed to inform future design, conduct, and planning of internet-administered intervention development and feasibility studies, especially within the context of digital health care research.
JMIR Publications JMIR Publications, 2021. Vol. 5, no 10, article id e26266
Digital healthcare research, feasibility study, internet-administered cognitive behavior therapy, low intensity CBT, parents