ABSTRACT
INTRODUCTION: Hypertension, the clinical condition of persistent high blood pressure (BP), is preventable yet remains a significant contributor to poor cardiovascular outcomes. Digital self-management support tools can increase patient self-care behaviours to improve BP. We created a patient-facing and provider-facing clinical decision support (CDS) application, called the Collaboration Oriented Approach to Controlling High BP (COACH), to integrate home BP data, guideline recommendations and patient-centred goals with primary care workflows. We leverage social cognitive theory principles to support enhanced engagement, shared decision-making and self-management support. This study aims to measure the effectiveness of the COACH intervention and evaluate its adoption as part of BP management. METHODS AND ANALYSIS: The study design is a multisite, two-arm hybrid type III implementation randomised controlled trial set within primary care practices across three health systems. Randomised participants are adults with high BP for whom home BP monitoring is indicated. The intervention arm will receive COACH, a digital web-based intervention with effectively enhanced alerts and displays intended to drive engagement with BP lowering; the control arm will receive COACH without the alerts and a simple display. Outcome measures include BP lowering (primary) and self-efficacy (secondary). Implementation preplanning and postevaluation use the Consolidated Framework for Implementation Research and Reach-Effectiveness-Adoption-Implementation-Maintenance metrics with iterative cycles for qualitative integration into the trial and its quantitative evaluation. The trial analysis includes logistic regression and constrained longitudinal data analysis. ETHICS AND DISSEMINATION: The trial is approved under a single IRB through the University of Missouri-Columbia, #2091483. Dissemination of the intervention specifications and results will be through open-source mechanisms. TRIAL REGISTRATION NUMBER: NCT06124716.
Subject(s)
Hypertension , Humans , Hypertension/therapy , Self Care/methods , Blood Pressure Monitoring, Ambulatory/methods , Adult , Primary Health Care , Decision Support Systems, Clinical , Randomized Controlled Trials as Topic , Female , Self-Management/methodsABSTRACT
BACKGROUND: Excessive weight gain during pregnancy is associated with complications for both the mother and her infant including gestational diabetes, hypertensive disorders, operative delivery, and long-term obesity. A healthy diet during pregnancy promotes healthy gestational weight gain and determines fetal epigenetic programming in infants that impacts risk for future chronic disease. OBJECTIVE: This project will examine the impact of grocery delivery during pregnancy on the weight, diet, and health outcomes of young pregnant women and their infants. METHODS: A three-arm randomized controlled trial design will be performed. A total of 855 young pregnant women, aged 14-24 years, from across the state of Michigan will be enrolled and randomized equally into the three study arms. Participants in arm one (control) will receive usual care from the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC); arm two will receive WIC plus biweekly grocery delivery; and arm three will receive WIC plus biweekly grocery and unsweetened beverage delivery. Weight will be assessed weekly during pregnancy, and total pregnancy weight gain will be categorized as above, below, or within guidelines. Additionally, dietary intake will be assessed at three time points (baseline, second trimester, and third trimester), and pregnancy outcomes will be extracted from medical records. The appropriateness of pregnancy weight gain, diet quality, and occurrence of poor outcomes will be compared between groups using standard practices for multinomial regression and confounder adjustment. RESULTS: This study was funded in April 2021, data collection started in December 2021, and data collection is expected to be concluded in 2026. CONCLUSIONS: This study will test whether grocery delivery of healthy foods improves weight, diet, and pregnancy outcomes of young moms with low income. The findings will inform policies and practices that promote a healthy diet during pregnancy, which has multigenerational impacts on health. TRIAL REGISTRATION: ClinicalTrials.gov NCT05000645; https://clinicaltrials.gov/ct2/show/NCT05000645. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/40568.
