Lessons Learned Recruiting and Retaining Pregnant and Postpartum Individuals in Digital Trials: Viewpoint

Abstract

In an increasingly connected world and in the midst of a global pandemic, digital trials offer numerous advantages over traditional trials that rely on physical study sites. Digital trials have the potential to improve access to research and clinical treatments for the most vulnerable and minoritized, including pregnant and postpartum individuals. However, digital trials are underutilized in maternal and child health research, and there is limited evidence to inform the design and conduct of digital trials. Our research collaborative, consisting of 5 research teams in the U.S. and Australia, aimed to address this gap. We collaborated to share lessons learned from our experiences recruiting and retaining pregnant and postpartum individuals in digital trials of social and behavioral interventions. We first discuss the promise of digital trials in improving participation in research during the perinatal period, as well as the unique challenges they pose. Second, we present lessons learned from 12 completed and ongoing digital trials that have used platforms such as Ovia, Facebook, and Instagram for recruitment. Our trials evaluated interventions for breastfeeding, prenatal and postpartum depression, insomnia, decision making, and chronic pain. We focus on challenges and lessons learned in 3 key areas: (1) rapid recruitment of large samples with a diversity of minoritized identities, (2) retention of study participants in longitudinal studies, and (3) prevention of fraudulent enrollment. We offer concrete strategies that we pilot-tested to address these challenges. Strategies presented in this commentary can be incorporated, as well as formally evaluated, in future studies.

Decentralized Clinical Trials: Potentials for Equity in Digital Health

“…Furthermore, our findings indicate an increasing possibility for equal access and inclusion for diverse populations, home administration of medicine, retention and compliance, and monitoring of trial participants' safety. These findings comply with international literature [1,5,6,[9][10][11][12][13]. However, the literature also raises concerns that DCT can be exclusive to demographic characteristics, such as age, race, socioeconomic status, and rural living with poor internet connection, thereby creating inequity [12].…”

“…This may improve accessibility for minoritized populations or populations with rare diseases, who are often underrepresented in CTs. Therefore, DCT have the potential to facilitate Diversity, Equity, and Inclusion [7] of marginalized populations via Personalized Health [8] and improve their health literacy, patient empowerment and autonomy [1,5,6,[9][10][11][12].…”

“…DCT can facilitate the collection of diverse data from multiple sources, such as digital biomarkers, electronic health records, clinical and demographic data sources and patient-reported outcomes (PRO). Wearables can, for example, provide continuous monitoring of trial participants to rapidly identify adverse events [1,11,13].…”

Improving Maternal Depression Screening in the Neonatal Intensive Care Unit

“…To address low enrollment rates, recruitment later moved online and expanded to mothers living outside the state of Iowa. During the month of June 2021, mothers were recruited through an advertisement on Ovia Health, a smartphone application for new parents (Parks et al, 2022). Mothers who clicked on the advertisement were directed to the study's Redcap survey.…”

Mothers and Babies Online Course: Participant Characteristics and Behaviors in a Web-Based Prevention of Postpartum Depression Intervention

“…Similarly, recruitment for internet based PPD intervention programs can be challenging in reaching users it was designed for, or who would benefit from the intervention. Most recruitment in perinatal interventions comes from clinics, health providers, and self-referrals from online applications and media platforms (17). To further enhance online interventions and better understand the needs of organic users of perinatal interventions, we must examine their characteristics so recruitment and outreach efforts may be tailored with the goal of widespread global impact.…”