Clinical trial NCT02084992: A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure
Official title: A Multicenter Randomized Controlled Evaluation of Heart Failure Disease Management Using Advanced Telecommunications Within a Diverse Provider Network: The Specialized Primary and Networked Care in HF (SPAN-CHF) III Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Congestive Heart Failure
Diastolic Heart Failure
Systolic Heart Failure
Keywords: Congestive Heart Failure
Disease management
Hospitalization
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Metro West Medical Center
First posted: 2014-03-12
Enrollment: 212
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 tablet 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.


Eligibility criteria: Inclusion Criteria:

1. Patients age ≥ 18 with a primary care provider or specialist that is participating within the Collaborative Health ACO.
2. Patient able to consent
3. 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

Exclusion Criteria:

1. Acute myocardial infarction, PCI or CABG within 30 days before enrollment
2. Planned revascularization procedures, cardiac mechanical support implantation, cardiac transplantation, or other cardiac surgery within 30 days following study randomization.
3. Illness other than heart failure deemed the principal limitation to life expectancy or principal cause of disability
4. Severe angina as the principal cause of limitation
5. Uncorrected valvular disease, except where valvular regurgitation was considered to be secondary to severe left ventricular dilation, or where surgical correction is deemed excessively risky or declined by the patient.
6. Moderate to severe dementia such that unable to participate in disease management program
7. Severe visual or auditory disability such that unable to participate in disease management program
8. Hospice care
9. Listed for heart transplantation
10. No access to a working telephone
11. Homeless or no stable home environment
12. Not speaking a language in which the educational documents have been translated

Primary outcomes:
measure: Number of days hospitalized for heart failure per patient-year of follow-up
timeFrame: 90 days
Secondary outcomes:
measure: All Cause Mortality
timeFrame: 90 days
measure: Cardiovascular Mortality
timeFrame: 90 days
measure: Number of days hospitalized for cardiovascular causes at 90 days
timeFrame: 90 days
measure: Number of days hospitalized for any cause
timeFrame: 90 days
measure: Change in health status as assessed by the SF-12
timeFrame: 90 days
measure: Change in self-care as assessed by the SCHFI
timeFrame: 90 days
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Framingham
country: United States
facility: MetroWest Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Marvin A Konstam, MD
role: PRINCIPAL_INVESTIGATOR
References: