Heart Failure
Conditions
Keywords
Heart failure, Quality of life
Brief summary
This study examines whether a nurse monitored management program at the hospital heart failure outpatient clinic can improve quality of life in elderly patients with chronic heart failure, as compared to standard treatment in primary healthcare.
Detailed description
Patients 60 years of age or more hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV and systolic dysfunction (left ventricular ejection fraction less than 0.45) are investigated before discharge and than randomized to the nurse monitored management program or to standard care. Examinations are performed at 0, 6, 12, and 18 months, and include clinical signs and symptoms, quality of life, biochemical assessment, echocardiography and drugs used. The study will be completed when all patients have passed the 18 month follow up examination. Quality of life is assessed by the Nottingham health profile.
Interventions
PROCEDURENurse monitored heart failure program
Standard program for a heart failure clinic with information, education, drug titration
PROCEDUREStandard primary health care
Standard care in primary care according to national guidelines but at the discretion of the primary care caregiver
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients 60 years of age or older * Hospitalized with heart failure according to New York Heart Association (NYHA) class II-IV * Left ventricular systolic dysfunction with an ejection fraction below 0.45, by echocardiography
Exclusion criteria
* An acute myocardial infarction or unstable angina pectoris within the last three months * Valvular stenosis * Dementia * Severe concomitant disease * Refusal to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life | 18 months | Nottingham health profile used for quality of life assessment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalizations | 18 months | Registry data that cover all hospitalizations for all patients |
| Evaluation of heart failure medication | 18 months | Whether patients receive appropriate drug therapy (drug classes) and reach target doses of heart failure medication |
| Mortality | 18 months | Mortality from death certificates obtained. |
Countries
Sweden
Outcome results
None listed