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Completed

NCT Number: NCT00533013

Comprehensive Heart Failure Disease Management Community Program

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.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maccabi Health Services

Tel Aviv, Israel

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Usual Care

Other

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

Disease Management and Tele-Monitoring

Other

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.

Primary outcomes

  1. hospital admissions for heart failure or all-cause mortality

    Time frame: 5 years

Secondary outcomes

  1. Health-related Quality of Life;

    Time frame: 5 years

    SF-36 score

  2. Functional status

    Time frame: 5 years

    6-minute walk-test; NYHA classification category

Sponsors and collaborators

Lead sponsor

Sheba Medical Center

Other Gov

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2012
First posted
Sep 21, 2007
Registry last updated
Apr 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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