Congestive Heart Failure, Diastolic Heart Failure, Systolic Heart Failure
Conditions
Keywords
Congestive Heart Failure, Disease management, Hospitalization
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.
Interventions
OTHERExpanded technology disease management
Tablet computers loaded with a web-based disease management program will be given to patients for the duration of the study.
OTHERTelephonic disease management
Sponsors
Metro West Medical Center
Tufts Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of days hospitalized for heart failure per patient-year of follow-up | 90 days |
Secondary
| Measure | Time frame |
|---|---|
| Cardiovascular Mortality | 90 days |
| Number of days hospitalized for cardiovascular causes at 90 days | 90 days |
| All Cause Mortality | 90 days |
| Change in health status as assessed by the SF-12 | 90 days |
| Change in self-care as assessed by the SCHFI | 90 days |
| Number of days hospitalized for any cause | 90 days |
Countries
United States
Outcome results
None listed