A Study of a Technology-enabled Disease Management Program to Reduce Hospitalizations for Heart Failure

Status:	Recruiting
Conditions:	Cardiology
Therapuetic Areas:	Cardiology / Vascular Diseases
Healthy:	No
Age Range:	18 - Any
Updated:	2/9/2018
Start Date:	June 2014
End Date:	March 2019
Contact:	Jenica N Upshaw, MD
Email:	JUpshaw@tuftsmedicalcenter.org
Phone:	617 636 2273

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

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.

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

We found this trial at

sites

Tufts Medical Center

800 Washington St
Boston, Massachusetts 02111

(617) 636-5000