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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02084992
Other study ID # Verizon2014
Secondary ID 11111
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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