Design, rationale, and baseline characteristics of a randomized controlled trial evaluating a mobile relational agent to enhance atrial fibrillation self-care.

Atrial fibrillation (AF) is a chronic cardiovascular disease that frequently causes disruptive symptoms, adverse outcomes, and poor health-related quality of life (HRQoL). We have developed a mobile health application for individuals with AF which provides a longitudinal, patient-centered program to improve self-care. The defining feature of the application is the use of a relational agent, which uses synthetic speech accompanied by animation to provide health education, empathic counseling, and monitoring. In the present manuscript we present the design, rationale, and baseline characteristics of participants enrolled in "A Mobile Relational Agent to Enhance Atrial Fibrillation Self-Care Trial," a randomized trial testing the effectiveness the application for urban-dwelling individuals with AF being treated with oral anticoagulation for prevention of thromboembolic ischemic stroke. This is a single-center, parallel-arm randomized trial that assigned patients to the novel application (relational agent) versus a control intervention (WebMD). This ongoing RCT aims to determine the effect of the mobile health application on: (1) anticoagulation adherence; (2) patient-centered outcomes (quality of life and symptoms); and (3) health care utilization. The primary outcome, anticoagulation adherence, will be measured using the proportion of days covered (PDC). The study completed enrollment on April 1, 2022 (final enrollment n = 243 participants) with expected completion date of April 2023. (http://clinicaltrials.gov registration NCT04075994).

Brief motivational enhancement intervention to prevent or reduce postpartum alcohol use: a single-blinded, randomized controlled effectiveness trial.

AIMS: The aim of this study is to assess the effect of brief motivational enhancement intervention postpartum alcohol use. DESIGN: This study is a single-blinded, randomized controlled effectiveness trial in which pregnant women were assigned to receive usual care or up to 5 face-to-face brief motivational enhancement sessions lasting 10-30 minutes each and occurring at study enrollment, 4 and 8 weeks after enrollment, 32 weeks of gestation, and 6 weeks postpartum. SETTING: The setting is in a large, urban, obstetrics clinic. PARTICIPANTS: Participants were women who were ≥ 18 years old, <20 weeks of gestation, and consumed alcohol during pregnancy. Of 3438 women screened, 330 eligible women were assigned to usual care (n = 165) or intervention (n=165). Due to missing data, we analyzed 125 in the intervention group and 126 in the usual care group. MEASUREMENTS: The measurements were the proportion of women with any alcohol use and the number of drinks per day, reported via follow-up telephone interviews at 4 and 8 weeks after enrollment, 32 weeks of gestation, and 6 weeks, 6 months, and 12 months postpartum. FINDINGS: In random effects models adjusted for confounders, the intervention group was less likely to use any alcohol (odds ratio 0.50; 95% confidence interval [CI], 0.23-1.09; P=0.08) and consumed fewer drinks per day (coefficient -0.11; 95% CI -0.23-0.01; P=0.07) than, the usual care group in the postpartum period but these differences were non-significant. Missing data during the prenatal period prevented us from modeling prenatal alcohol use. CONCLUSIONS: Brief motivational enhancement intervention delivered in an obstetrical outpatient setting did not conclusively decrease alcohol use during the postpartum period.