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Article 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 app 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: We evaluated the impact of platform design and usability on adherence and retention with a longitudinal study involving repeated patient-facing study instruments. We expected participants assigned to complete instruments in the DCH mobile app to stay in this study longer (increased retention) and complete more surveys while in this study (increased adherence) due to the enhanced motivational elements unique to the participant experience in the DCH app group, and this group's overall lower burden of participation.
Methods: A total of 284 adult participants completed 24 weekly surveys via 1 of 4 modalities (DCH app vs DCH website vs third-party website vs paper) in a web-based and mobile longitudinal study. Participants were recruited from open access websites (eg, Craigslist or Facebook [Meta]), and a closed web-based user group. All participation occurred remotely. Study staff deliberately limited communications with participants to directly assess the main effects of survey administration modality; enrollment and study administration were largely automated. 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 passcodes or 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 web-based surveys via personalized emailed links with no need for password authentication. Paper arm participants received paper surveys in the mail.
Results: Mode of survey administration (DCH app vs DCH website vs third-party website vs paper) predicted study retention (F9,255=4.22, P<.001) and adherence (F9,162=5.5, P<.001). The DCH app group had greater retention than the paper arm (t=-3.80, P<.001), and comparable retention to the DCH website group. The DCH app group had greater adherence than all other arms (DCH web: t=-2.42, P=.02; third-party web: t=-3.56, P<.001; and paper arm: t=-4.53, P<.001).
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.
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| http://www.ncbi.nlm.nih.gov/pmc/articles/PMC11967695 | PMC |
| http://dx.doi.org/10.2196/50225 | DOI Listing |
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