Heart Failure
Conditions
Keywords
mobile application, mHealth
Brief summary
In the United States, about 40 percent of heart failure (HF) patients are readmitted within 1-year following their first admission for HF and hospitalization accounts for approximately 70 percent of the costs of HF management. As a result, the management of HF patients is evolving from the traditional model of face-to-face follow-up visits toward a proactive real-time technological model of assisting patients with monitoring and self-management while in the community. The investigators plan to test the impact of a mobile application on clinical outcomes in HF.
Detailed description
HF patients with a reduced ejection fraction will be randomized to the mobile application versus placebo for 12 weeks. The mobile application will provide the participants with a reminder to perform self-monitoring, a health status indicator and heart failure education for self-management. All participants will complete the Minnesota Living with Heart Failure Questionnaire and Self-Care Heart Failure Index. Hospital admissions and mortality will also be collected.
Interventions
BEHAVIORALMobile Application
Participants will use the mobile application daily to assess heart failure symptoms.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 45 years old or older * Left ventricular ejection fraction \</= 40% or an LVEF \> 40% (with left atrial size \>40mm or BNP \> 200 pg/ml or NT-proBNP \> 800 pg/ml) * Admitted for acutely decompensated heart failure or recently discharged in the past 4 weeks. * Smartphone (iOS or Android) with home wifi
Exclusion criteria
* Unstable coronary syndrome within 8 weeks (unstable angina, NSTEMI, STEMI) * Primary valvular heart disease * Known pericardial disease (Sarcoidosis, amyloidosis, rheumatoid arthritis, lupus) * Uncorrected thyroid disease * Advanced renal disease (dialysis or creatinine \>4.0 mg/dL) * End-stage HF (hospice candidate, home milrinone or dobutamine) * Active cancer * Pulmonary fibrosis * Discharge to a setting other than home
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Minnesota Living with Heart Failure Questionnaire (MLHFQ) | Change from Baseline MLHFQ at Week 12 | MLHFQ is a quality of life questionnaire for heart failure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-Care Heart Failure Index (SCHFI) | Change from Baseline SCHFI at Week 12 | SCHFI is a survey of heart failure patient self-management. |
| Hospitalizations | Over 12 weeks | Admission to the hospital while enrolled in the trial. |
| Mortality | Over 12 weeks | Death while enrolled in the trial. |
Countries
United States
Outcome results
None listed