From hybrid to fully remote clinical trial amidst the COVID-19 pandemic: Strategies to promote recruitment, retention, and engagement in a randomized mHealth trial

Leigh Ann Simmons, Jennifer E Phipps, Mackenzie Whipps, Paige Smith, Kathryn A Carbajal, Courtney Overstreet, Jennifer McLaughlin, Koen De Lombaert, Devon Noonan, Leigh Ann Simmons, Jennifer E Phipps, Mackenzie Whipps, Paige Smith, Kathryn A Carbajal, Courtney Overstreet, Jennifer McLaughlin, Koen De Lombaert, Devon Noonan

Abstract

Clinical trials worldwide were disrupted when the COVID-19 pandemic began in early 2020. Most intervention trials moved to some form of remote implementation due to restrictions on in-person research activities. Although the proportion of remote trials is growing, they remain the vast minority of studies in part due to few successful examples. Our team transitioned Goals for Reaching Optimal Wellness (GROWell), an NIH-funded (R01NR017659) randomized control trial (RCT; ClinicalTrials.gov identifier NCT04449432) originally designed as a hybrid intervention, into a fully remote clinical trial. GROWell is a digital dietary intervention for people who enter pregnancy with overweight or obesity. Primary outcomes include gestational weight gain and six-month postpartum weight retention. Strategies that we have tested, refined, and deployed include: (a) use of a HIPAA-compliant, web-based participant recruitment and engagement platform; (b) use of a HIPAA-compliant digital health platform to disseminate GROWell and conduct study visits (c) interconnectivity of these two platforms for seamless recruitment, consent, enrollment, intervention delivery, follow-up, and study team blinding; (d) detailed SMS messages to address initial challenges with protocol adherence; (e) email notifications alerting the study team about missed participant surveys so they can follow-up; (f) remuneration using email gift cards with recipient choice of vendor; and (g) geotargeting social media campaigns to improve participation of Black Indigenous and People of Color Communities. These strategies have resulted in screen failure rates improving by 7%, study task adherence improving by an average of 20-30% across study visits, and study completion rates of 82%. Researchers may consider some or all of these approaches in future remote mHealth trials.

Keywords: apps; behavior change; diet; digital clinical trials; digital health; general; lifestyle; mHealth; media; medicine; obesity; personalized medicine; pregnancy; psychology; remote clinical trials; studies.

© The Author(s) 2022.

Figures

Figure 1.
Figure 1.
Protocol changes and associated improvements.

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Source: PubMed

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