Comprehensive Heart Failure Disease Management Community Program

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Other: Usual Care; Other: Disease Management and Tele-Monitoring

• Registration Number: NCT00533013
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-09-20
• Study First Submitted QC: 2007-09-20
• Study First Posted: 2007-09-21
• Primary Completion: 2012-07
• Study Completion: 2012-07
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-03
• Last Update Posted: 2019-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1360

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual care	Usual Care	Management of heart failure is provided by primary practitioners and consultant cardiologists
Disease Management	Disease Management and Tele-Monitoring	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.

Primary Outcome Measures

Name	Time	Method
hospital admissions for heart failure or all-cause mortality	5 years

Secondary Outcome Measures

Name	Time	Method
Health-related Quality of Life;	5 years	SF-36 score
Functional status	5 years	6-minute walk-test; NYHA classification category

Trial Locations

Locations (1)

Maccabi Health Services; 🇮🇱 Tel-Aviv, Israel