Heart failure in the elderly Circulatory System Heart failure
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients aged over 65 2. Discharged home or to a nursing home without medical staff after a hospitalization due to heart failure of at least 48 hours of hospital stay (determined according to the European Society of Cardiology guidelines)
Exclusion criteria
Exclusion criteria: 1. Planned discharge to a long-term care facility or nursing home with medical staff 2. Severe dementia or other serious psychiatric illness 3. Confined to bed 4. Anticipated survival of less than 6 months 5. Foreseeable follow-up problems such as residence outside the hospital catchment area 6. Refusal to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Estimated event-free survival, defined on the basis of time to first event (any cause readmission or death) at 1 year. Kaplan?Meier survival curves will be constructed to assess differences in deaths or readmissions between groups and compared using the log rank test. Data for all event-free patients will be censored on study day 365. Event-free survivals will be tested with the Cox proportional hazards method. 2. Cost-effectiveness analysis. We will estimate costs from a societal perspective and will be included medical and non-medical costs. The effectiveness will be expressed in Quality-Adjusted Life Years (QALY) and will be calculated from the data of the Health Related Quality of Life (HRQL) obtained from the generic EuroQol-5D questionnaire. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Evaluate health-related quality of life: For health-related quality of life, the Minnesota Living With Heart Failure Questionnaire (MLWHFQ) score at baseline and 12 months will be calculated for each group in the trial. The effect of the DMP on quality of life will be estimated as the difference between groups in the change in MLWHFQ scores during the study. 2. Functional status: Assessed as ability to perform basic activities of daily living, the Barthel index (BI) score at baseline and 12 months will be calculated for each group in the trial. The effect of the DMP on functional status will be estimated as the difference between groups in the change in BI scores during the study. | — |
Countries
Spain