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

September 20, 2007
April 25, 2013
August 2007
July 2012   (final data collection date for primary outcome measure)
hospital admissions for heart failure or all-cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]
hospital admissions for heart failure or all-cause mortality [ Time Frame: One year ]
Complete list of historical versions of study NCT00533013 on ClinicalTrials.gov Archive Site
  • Quality of life; [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Functional status [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Quality of life; [ Time Frame: One years ]
  • Functional status [ Time Frame: One years ]
Not Provided
Not Provided
 
Comprehensive Heart Failure Disease Management Community Program
Comprehensive Program for Disease Management in Heart Failure Patients in the Community

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Heart Failure
  • Other: Usual Care
    Management of heart failure is provided by primary practitioners and consultant cardiologists
  • 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.
  • Active Comparator: Usual care
    Management of heart failure is provided by primary practitioners and consultant cardiologists
    Intervention: Other: Usual Care
  • 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.
    Intervention: Other: Disease Management and Tele-Monitoring
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1360
July 2012
July 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00533013
SHEBA-07-4807-OK-CTIL
No
Ofra Kalter-Leibovici MD, Sheba Medical Center
Ofra Kalter-Leibovici MD
Maccabi Healthcare Services, Israel
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
Sheba Medical Center
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP