JMIR Publications

ABSTRACT

Background:

Low retention and adherence increase clinical trial costs and timelines. Burdens associated with participating in a clinical trial contribute to early study termination. Electronic patient reported outcome (ePRO) tools reduce participant burden by allowing remote participation, and facilitate communication between researchers and participants. The Datacubed Health (DCH) mobile application is unique among ePRO platforms in its application of behavioral science principles (reward, motivation, identity, etc.) in clinical trials to promote engagement, adherence, and retention.

Objective:

This study aimed to evaluate the impact of platform design and usability on adherence and retention in longitudinal studies involving completion of repeated, patient-facing study instruments. We expected participants assigned to complete instruments in the DCH mobile application to stay in the study longer (increased retention) and complete more surveys while in the study (increased adherence) as a consequence of the enhanced motivational elements unique to the participant experience in the DCH App group, and this group’s overall lower burden of participation.

Methods:

284 adult participants were randomly assigned to complete 24 weekly surveys via 1 of 4 modalities (DCH App vs. DCH Website vs. Third-Party Website vs. Paper) in a virtual, siteless longitudinal study. Study arms differed in their design attributes. Participants assigned to the DCH App group experienced behavioral-science driven motivational elements related to reward and identity formation throughout their study journey. There was no homolog to this feature in any other tested platform. Participants assigned to the DCH App group accessed study measures using smartphone biometrics (Face or Touch ID). Participants in the DCH Website group logged into a website using a username and password. Participants in the Third-Party Website group accessed online surveys via personalized emailed links with no need for password authentication. Paper arm participants received paper surveys in the mail.

Results:

The DCH App and Third-Party Website groups had higher retention than participants in the DCH Website or Paper groups (P<.001). Any ePRO platform had higher retention than the Paper group (P<.001). The DCH App group had higher adherence with weekly survey completion than the Third-Party Website group (P<.001). All ePRO platforms had higher adherence than the Paper group (P<.05).

Conclusions:

Using an ePRO platform in a longitudinal study increased retention and adherence in comparison to paper instruments. Incorporating behavioral science design in an ePRO platform resulted in further increase in adherence in a longitudinal study.