Back to resultsComprehensive Heart Failure Disease Management Community Program
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Usual Care
Disease Management and Tele-Monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Heart Failure
Eligibility 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
Sites / Locations
- Maccabi Health Services
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Usual care
Disease Management
Arm Description
Management of heart failure is provided by primary practitioners and consultant cardiologists
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.
Outcomes
Primary Outcome Measures
hospital admissions for heart failure or all-cause mortality
Secondary Outcome Measures
Health-related Quality of Life;
SF-36 score
Functional status
6-minute walk-test; NYHA classification category
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00533013
Brief Title
Comprehensive Heart Failure Disease Management Community Program
Official Title
Comprehensive Program for Disease Management in Heart Failure Patients in the Community
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
August 2007 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sheba Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1360 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
Management of heart failure is provided by primary practitioners and consultant cardiologists
Arm Title
Disease Management
Arm Type
Experimental
Arm Description
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 Type
Other
Intervention Name(s)
Usual Care
Intervention Description
Management of heart failure is provided by primary practitioners and consultant cardiologists
Intervention Type
Other
Intervention Name(s)
Disease Management and Tele-Monitoring
Intervention Description
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 Outcome Measure Information:
Title
hospital admissions for heart failure or all-cause mortality
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Health-related Quality of Life;
Description
SF-36 score
Time Frame
5 years
Title
Functional status
Description
6-minute walk-test; NYHA classification category
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haim Silber, M.D.
Organizational Affiliation
Maccabi Healthcare Services, Israel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ofra Kalter-Leibovici, M.D.
Organizational Affiliation
Sheba Medical Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Galit Kaufman, RN
Organizational Affiliation
Sheba Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Maccabi Health Services
City
Tel-Aviv
Country
Israel
12. IPD Sharing Statement
Citations:
PubMed Identifier
28457231
Citation
Kalter-Leibovici O, Freimark D, Freedman LS, Kaufman G, Ziv A, Murad H, Benderly M, Silverman BG, Friedman N, Cukierman-Yaffe T, Asher E, Grupper A, Goldman D, Amitai M, Matetzky S, Shani M, Silber H; Israel Heart Failure Disease Management Study (IHF-DMS) investigators. Disease management in the treatment of patients with chronic heart failure who have universal access to health care: a randomized controlled trial. BMC Med. 2017 May 1;15(1):90. doi: 10.1186/s12916-017-0855-z.
Results Reference
result
Learn more about this trial
Comprehensive Heart Failure Disease Management Community Program
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