Heart Failure
Conditions
Brief summary
The purpose of this study is to determine whether a nurse-led, comprehensive disease management program is effective in reducing recurrent hospital admissions and deaths in community dwelling patients with moderate to severe heart failure.
Detailed description
Heart failure remains a significant cause of death, in spite of recent declines in overall mortality from cardiovascular disease. Heart failure is associated with increasing costs for healthcare, mainly for recurrent hospital admissions. Disease management programs aimed to improve patients outcome while containing healthcare costs,were employed in heart failure patients with varying results. Such programs contain various components, including patient education and empowerment, monitoring patients' adherence to therapy, telemonitoring of vital parameters, etc. Designated heart failure clinics were also employed in care given to these patients.
Interventions
OTHERUsual Care
Management of heart failure is provided by primary practitioners and consultant cardiologists
OTHERDisease Management and Tele-Monitoring
Management of heart failure is provided by cardiologists at regional heart failure clinics and by nurse practitioners at regional heart failure clinics and a designated call center. Decisions on treatment are guided by designated protocols and information derived for tele-monitoring of blood pressure, body weight and pulse rate.
Sponsors
Sheba Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Adult patients with NYHA-Stage III-IV heart failure recruited in the community; 2. Adult patients with NYHA-Stage II-IV heart failure recruited after hospital admission for decompensated heart failure
Exclusion criteria
* Other severe disease (e.g. end stage renal disease, metastatic cancer); bedridden or severely compromised functional status due to other diseases; drug or alcohol abuse; Severe cognitive impairment; People unconnected to telephone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| hospital admissions for heart failure or all-cause mortality | 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related Quality of Life; | 5 years | SF-36 score |
| Functional status | 5 years | 6-minute walk-test; NYHA classification category |
Countries
Israel
Outcome results
None listed