COMPLETED

The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients

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Conditions

Heart Failure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The SmartHF study is a 12-week prospective randomized controlled multicenter clinical trial. This study will investigate the efficacy of an adaptive web application to facilitate guideline-directed medical therapy (GDMT) optimization in HFrEF patients. Eligible participants will be randomized to the web application intervention or control in a 1:1 manner, stratified by site. The intervention is an adaptive medication optimization web application that extracts and analyzes the EHR data with a computable medication optimization algorithm. The algorithm provides a medication quality score and outputs medication optimization recommendations written in a patient -friendly manner.

Official Title

The Impact of an Adaptive Patient-centered Web Application on Medication Optimization in HFrEF Patients (SmartHF)

Quick Facts

Study Start:2023-07-21
Study Completion:2025-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05858320

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 18 years and older at screening
  2. 2. Diagnosis of heart failure with a left ventricular ejection fraction (LVEF) \</= 40% (HFrEF)
  3. 3. Have a general medicine provider or general cardiology provider for HFrEF
  4. 4. Have internet access and access to their health system's patient portal
  5. 5. Fluent in spoken and written English
  6. 6. At least two of the following: systolic blood pressure ≥ 110mmg, potassium ≤ 5.5, serum creatinine ≤ 2.5, heart rate ≥ 70
  7. 7. At least two eligible heart failure therapies (guideline-recommended BB, RASI, MRA, or SGLT2i) not yet initiated or below 50% of the target dose
  1. 1. End-stage HF (hospice candidate)
  2. 2. Actively treated cancer, except non-melanoma skin cancer
  3. 3. Implanted ventricular assist device
  4. 4. Current treatment with chronic inotropic therapy
  5. 5. Patient's provider for HFrEF care is considered an advanced HF specialist
  6. 6. Currently pregnant or intends to become pregnant during the study period
  7. 7. Dialysis

Contacts and Locations

Study Locations (Sites)

Emory University, Grady Hospital
Atlanta, Georgia, 30303
United States
University of Michigan
Ann Arbor, Michigan, 48109
United States
Henry Ford Hospital and Health System
Detroit, Michigan, 48202
United States
Trinity Healthcare St. Joseph Mercy Ann Arbor
Ypsilanti, Michigan, 48197
United States
Washington University, Barns Jewish Hospital
St Louis, Missouri, 63110
United States

Collaborators and Investigators

Sponsor: University of Michigan

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-21
Study Completion Date2025-12-01

Study Record Updates

Study Start Date2023-07-21
Study Completion Date2025-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Heart Failure