Supplement study update for Reach Out: a multi-arm randomized trial of behavioral interventions for hypertension initiated in the emergency department: Reach Out Cognition

Background Reach Out is a factorial trial studying multicomponent behavioral interventions to reduce blood pressure in hypertensive emergency department patients. The original study protocol was published in June 2020. Here, we describe the updated protocol, including a supplemental study, Reach Out Cognition. Reach Out Cognition is a remote study that will assess the acceptability, feasibility, and satisfaction of digital, self-administered cognitive assessments and Bluetooth-enabled, self-measured blood pressure monitoring in the Reach Out population. We will also estimate the prevalence of mild cognitive impairment in Reach Out participants. Methods Reach Out Cognition includes remote enrollment and follow-up assessments. Reach Out Cognition extends Reach Out data collection past the current 12 months to 15 and 18 months. Participants will be Reach Out participants who complete their 12-month outcome assessments and opt to continue in the cohort study. Participants will continue to receive the Reach Out intervention, consisting of (1) daily healthy behavior text messaging and (2) weekly self-measured blood pressure monitoring. Blood pressure will be measured using Bluetooth-enabled self-measured blood pressure monitoring devices, and cognition will be measured using digital self-administered cognitive assessments at 12, 15, and 18 months. Discussion Reach Out Cognition will explore the potential of remote, digital, self-administered assessments of blood pressure and cognition among predominantly working-age Black Americans. Reach Out Cognition will inform future clinical trials and clinical remote monitoring of blood pressure and cognition that may lead to new approaches to treating and reducing hypertension and cognitive disparities. Trial registration ClinicalTrials.gov NCT03422718. The record was first available to the public on January 30, 2018, prior to the enrollment of patients on March 25, 2019.