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SPAN-CHF III


Title A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure (SpanCHFIII)
Therapeutic Area Congestive Heart Failure, Cardiomyopathy, Cardiac Failure, Heart Diseases, Heart Failure
Principal Investigator Jenica Upshaw, MD
Min Age 18 Years
Gender Both
Contact Jenica Upshaw
617 636-2273
More Information https://clinicaltrials.gov/ct2/show/NCT02084992

Overview

This study will randomize participants with a diagnosis of congestive heart failure and at least one risk factor for hospitalization to either a tablet computer and web based disease management program or a telephone based disease management program. Both interventions are home based with heart failure education and symptom monitoring provided by nurse managers. The nurse managers are in close communication with both the participants and the participants' physicians . The components of the disease management program have been developed at Tufts Medical Center and the New England Quality Care Alliance with studies showing improved clinical outcomes, including reduced hospitalizations. The goal of this study is to transition this successful home monitoring and disease management program to a table computer and web-based implementation to both improve clinical outcomes (reducing hospitalizations and improving self-perceived health status) and improve provider-patient satisfaction. We hypothesize that the tablet computer based disease management will decrease heart failure hospitalizations.

Study Details

Inclusion Criteria

  • Patients age ≥ 18 with a primary care provider or specialist that is participating within the Collaborative Health ACO.
  • Patient able to consent
  • A diagnosis of heart failure with at least one of the following risk factors:
    • Hospitalization for heart failure within the prior year
    • NYHA class III-IV symptoms
    • Most recent BNP ≥ 300 pg/mL (or Nt-proBNP ≥ 600 pg/mL) as long as within 90 days prior to enrollment ul>

    Exclusion Criteria

    • Acute myocardial infarction, PCI or CABG within 30 days before enrollment
    • Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
    • Illness/condition other than heart failure deemed to be the principal limitation to life expectancy or principal cause of disability

    Study Requirements

    This study consists of two visits to the participant’s home with each visit lasting one (1) to two (2) hours. Participants will be randomly assigned to either a computer tablet or telephone based disease management program. Participants will be asked to record their blood pressure, heart rate, and weight daily. All equipment, including a blood pressure cuff, a scale, and a computer tablet (if assigned to the tablet group) will be provided at no cost. All participants must have an active telephone number to be eligible. The duration of the study is ninety (90) days.