Comprehensive Heart Failure Disease Management Community Program

This study has been completed.
Sponsor:
Collaborator:
Maccabi Healthcare Services, Israel
Information provided by (Responsible Party):
Ofra Kalter-Leibovici MD, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT00533013
First received: September 20, 2007
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Heart Failure
Other: Usual Care
Other: Disease Management and Tele-Monitoring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comprehensive Program for Disease Management in Heart Failure Patients in the Community

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • hospital admissions for heart failure or all-cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of life; [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Enrollment: 1360
Study Start Date: August 2007
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care
Management of heart failure is provided by primary practitioners and consultant cardiologists
Other: Usual Care
Management of heart failure is provided by primary practitioners and consultant cardiologists
Experimental: Disease Management
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
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533013

Locations
Israel
Maccabi Health Services
Tel-Aviv, Israel
Sponsors and Collaborators
Ofra Kalter-Leibovici MD
Maccabi Healthcare Services, Israel
Investigators
Principal Investigator: Haim Silber, M.D. Maccabi Healthcare Services, Israel
Principal Investigator: Ofra Kalter-Leibovici, M.D. Sheba Medical Center
Study Director: Galit Kaufman, RN Sheba Medical Center
  More Information

No publications provided

Responsible Party: Ofra Kalter-Leibovici MD, Dr. Ofra Kalter-Leibovici, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT00533013     History of Changes
Other Study ID Numbers: SHEBA-07-4807-OK-CTIL
Study First Received: September 20, 2007
Last Updated: April 25, 2013
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Additional relevant MeSH terms:
Heart Failure
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on October 23, 2014