Comprehensive Heart Failure Disease Management Community Program

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00533013
• Other study ID #: SHEBA-07-4807-OK-CTIL
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: July 2012

Study information

• Verified date: April 2019
• Source: Sheba Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1360
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Other:
• Usual Care
Management of heart failure is provided by primary practitioners and consultant cardiologists
• 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.

Locations

Country	Name	City	State
Israel	Maccabi Health Services	Tel-Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hospital admissions for heart failure or all-cause mortality		5 years
Secondary	Health-related Quality of Life;	SF-36 score	5 years
Secondary	Functional status	6-minute walk-test; NYHA classification category	5 years