Comprehensive Heart Failure Disease Management Community Program
This study has been completed.
Sponsor:
Ofra Kalter-Leibovici MD
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
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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:
- 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
Contacts and Locations
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 Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013