Comprehensive Heart Failure Disease Management Community Program

Sheba Medical Center

Status: Completed

Conditions: Heart Failure

Treatments: Other: Disease Management and Tele-Monitoring; Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT00533013

SHEBA-07-4807-OK-CTIL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,360 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,360 participants in 2 patient groups

Usual care

Active Comparator group

Description:

Management of heart failure is provided by primary practitioners and consultant cardiologists

Treatment:

Other: Usual Care

Disease Management

Experimental group

Description:

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.

Treatment:

Other: Disease Management and Tele-Monitoring