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

Congestive Heart Failure Clinical Trial

— SpanCHFIII  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084992
• Other study ID #: Verizon2014
• Secondary ID: 11111
• Status: Completed
• Phase: N/A
• Start date: June 2014
• Est. completion date: September 1, 2019

Study information

• Verified date: October 2019
• Source: Tufts Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 212
• Est. completion date: September 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Congestive Heart Failure
• Diastolic Heart Failure
• Heart Failure
• Heart Failure, Diastolic
• Heart Failure, Systolic
• Systolic Heart Failure

Intervention

Other:
• Expanded technology disease management
Tablet computers loaded with a web-based disease management program will be given to patients for the duration of the study.
• Telephonic disease management

Locations

Country	Name	City	State
United States	Tufts Medical Center	Boston	Massachusetts
United States	MetroWest Medical Center	Framingham	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Tufts Medical Center	Metro West Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of days hospitalized for heart failure per patient-year of follow-up		90 days
Secondary	All Cause Mortality		90 days
Secondary	Cardiovascular Mortality		90 days
Secondary	Number of days hospitalized for cardiovascular causes at 90 days		90 days
Secondary	Number of days hospitalized for any cause		90 days
Secondary	Change in health status as assessed by the SF-12		90 days
Secondary	Change in self-care as assessed by the SCHFI		90 days