Comprehensive Heart Failure Disease Management Community Program

Study Overview
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Brief Summary
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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
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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.

Official Title
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Comprehensive Program for Disease Management in Heart Failure Patients in the Community

Conditions
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Heart Failure

Intervention / Treatment
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* Other: Usual Care
* Other: Disease Management and Tele-Monitoring


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients with NYHA-Stage III-IV heart failure recruited in the community; 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>Management of heart failure is provided by primary practitioners and consultant cardiologists | Other: Usual Care<br>* Management of heart failure is provided by primary practitioners and consultant cardiologists<br>|
| Experimental: Disease Management<br>Disease management led by nurse specialists in regional Heart Failure Clinics and a national Call Center. Tele-Monitoring of body weight, pulse rate and blood pressure is performed at participants' homes. | Other: Disease Management and Tele-Monitoring<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hospital admissions for heart failure or all-cause mortality |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related Quality of Life; | SF-36 score | 5 years | 
| Functional status | 6-minute walk-test; NYHA classification category | 5 years |