CONNECT-HF is a research study and remote care program powered by

CONNECT-HF is a large, multi-site research study that includes an ancillary study/app designed to support guideline-based activities to help patients manage heart failure. The Pattern-powered app tracked key biometrics and delivered personalized educational content about heart failure and help patients manage taking their medication.
Principle Investigators: Adam DeVore, MD, MHS
Institution: Duke Clinical Research Institute (DCRI)
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Clinicaltrials.gov Identifiers: NCT03035474
Trial Design: Multi-site, Hybrid
Funding: National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)

“This trial will be a large-scale, pragmatic, cluster-randomized clinical trial to evaluate the effect of a customized, multifaceted, health system-level quality-improvement (QI) program compared with usual care on heart failure (HF) outcomes and HF quality-of-care metrics. Outcomes will be assessed following discharge for participants hospitalized with acute HF and reduced left ventricular ejection fraction. All participants in the trial will be consented for follow-up as part of the CONNECT-HF registry on clinical outcomes, medication use, and participant-centered outcomes, including quality-of-life (QOL) assessments will be collected up to 12 months post-discharge at pre-specified intervals (6 weeks and 3, 6, and 12 months).

The health-system QI program will involve site visits and ongoing mentoring from teams of healthcare professionals with specialized training and field experience to help health systems and individual hospitals to design local QI plans.

A key substudy will assess a participant-engagement strategy (digital) of a mobile application utilizing behavioral tools to reinforce health behaviors, including self-monitoring/self-management and medication adherence.

Follow-up will occur via a centralized telephone interview by trained personnel via the DCRI Call Center. At each interview, participants will be asked to report current medications, rehospitalizations, and QOL assessments. Based on participant-reported events, medical billing data for rehospitalizations, emergency department visits, and procedures will be obtained.

Quality of life assessments will include the Kansas City Cardiomyopathy Questionnaire (KCCQ) and EuroQOL five dimensions questionnaire (EQ-5D).” (NCT03035474)

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