Improving Study Management Services for Mhealth Interventions – a Dynamic Concept for More Efficient Trials

Background

Clinical trials are notoriously falling behind schedule and over budget. In fact, nearly 90% of clinical trials fail to reach intended outcomes on time. Today, mHealth technologies, provide additional challenges by developing faster than clinical trials are able to evaluate them, raising the challenge of adapting our approach to RCTs, especially concerning self-management interventions. In response, a dynamic study-management platform was developed (Figure 1) to improve study efficiency and tried out in an RCT intervention spanning 10 months (January-November 2017), 6 months per participant.

Method

Amount of time that a study manager spent using the platform to complete each task per stage of the RCT was approximated.

Results

Recruitment spanned 11 weeks. The study manager spent the following amount of time on each task per participant: Informed consent delivery and collection (2-minutes); Randomization (1-minute); Delivery of the Initial questionnaire (1-minute); App administration (4-minutes); Mid-study questionnaire (1-minute); and Final questionnaire (1-minutes). Minutes spent logging into the system, checking participant status, sending questionnaire reminders, etc. approximately tripled these times – totaling 30-minutes per user. Time spent on data-gathering and analysis are being processed.

Conclusion

The most challenged task in the process is still recruitment. Otherwise the most time consuming functionalities were the creation of the study elements: questionnaire, app-related materials, recruitment texts, administrative project documents and webpage, etc. We demonstrated the potential of efficiently managing a study involving mHealth technologies using the presented platform. Final results, as well as times that participants spent per study task, will be reported in coming venues and publications.

We are using this concept in an ongoing clinical trial (Full Flow of Health Data Between Patients and Health Care Systems), for further test of the potential.