Differential Pandemic Impact on a Health Technology Intervention in Diverse Health Systems: Updates on the mGlide Randomized Controlled Trial (Preprint)

BACKGROUND The mGlide randomized clinical trial (RCT) is an NIH-funded study, evaluating whether a mobile health (mHealth)-based intervention that facilitates an active partnership between interprofessional health-care teams and patients results better hypertension (HTN) control than a state-of-clinical-care comparison in patients with uncontrolled HTN. The intervention uses readily available smartphone technology. OBJECTIVE The mGlide RCT was implemented in diverse health systems and was ongoing during the pandemic. The protocol was previously published. We describe the differential impact of the pandemic and consequent protocol updates and study timeline changes. METHODS We enrolled participants with uncontrolled HTN who were stroke survivors or primary care patients with elevated cardiovascular disease (CVD) risk from diverse health systems. Planned recruitment sites included primary care clinics and specialty stroke service in an integrated academic health system as well as university-affiliated community clinics and federally qualified health centers (FQHC). The FQHC and community clinics predominantly serve low-income patients and diverse racial/ethnic minorities - including African American, Hmong, and Latino patients. The primary aim tests the clinical effectiveness of reducing SBP of the 6-month mHealth intervention versus standard of care. Secondary aims evaluate sustained HTN control at 12 months, provider experiences of system usability, patient experiences, (including medication adherence, medication use self-efficacy, self-rated health, and quality of life), and adverse event rates. RESULTS Trial recruitment commenced in 2019 and enrollment of 395 participants was completed in August 2023. The last follow-up will be completed in August 2024. The pandemic severely disrupted trial operations. On 3/16/2020, a moratorium on active clinical research was enacted within our health system in order to minimize in-person contact. All mGlide recruitment, enrollment, and follow-up activities ceased. Subsequently, the research team developed remote enrollment and follow-up processes that were utilized until COVID-19 vaccines became available in early 2021. A differential pandemic impact on health system research capacity was noted. The standalone FQHC had the highest rates of study drop-outs and was not able to recover its research capacity post-pandemic. Many clinics, however, including community clinics were impacted in the short-term but recovered their research capacity. Enrollments at the integrated health system were least impacted. Some rural clinics that were added for recruitment later in the study, (September 2022), showed robust participation. The Data Safety Monitoring Board reviewed two interim analyses (December 2021 and October 2022) and recommended that the primary analysis use a continuous endpoint of mean systolic blood pressure difference between the two arms in addition to a dichotomous endpoint of <140 mm Hg. Consequently, the needed sample size was lowered. CONCLUSIONS We describe the dynamics of implementing a technology-based intervention with real-world challenges when participants and healthcare systems are significantly impacted by a disruptive pandemic. CLINICALTRIAL Clinicaltrials.gov: NCT03612271 https://clinicaltrials.gov/study/NCT03612271