NCT00533013

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,360

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Aug 2007

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 20, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

April 5, 2019

Status Verified

April 1, 2019

Enrollment Period

4.9 years

First QC Date

September 20, 2007

Last Update Submit

April 3, 2019

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (1)

  • hospital admissions for heart failure or all-cause mortality

    5 years

Secondary Outcomes (2)

  • Health-related Quality of Life;

    5 years

  • Functional status

    5 years

Study Arms (2)

Usual care

ACTIVE COMPARATOR

Management of heart failure is provided by primary practitioners and consultant cardiologists

Other: Usual Care

Disease Management

EXPERIMENTAL

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

Interventions

Usual CareOTHER

Management of heart failure is provided by primary practitioners and consultant cardiologists

Usual care
Disease Management and Tele-MonitoringOTHER

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.

Disease Management

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maccabi Health Services

Tel Aviv, Israel

Location

Related Publications (2)

  • 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.

    PMID: 28457231RESULT

  • Kalter-Leibovici O, Murad H, Ziv A, Keidan T, Orion A, Afel Y, Gilutz H, Freimark D, Klibansky-Marom R, Freedman L, Silber H. Causes and predictors of recurrent unplanned hospital admissions in heart failure patients: a cohort study. Intern Emerg Med. 2024 Nov;19(8):2213-2221. doi: 10.1007/s11739-024-03740-2. Epub 2024 Aug 18.

    PMID: 39154298DERIVED

MeSH Terms

Conditions

Heart Failure

Interventions

Disease Management

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Patient Care ManagementHealth Services Administration

Study Officials

  • Haim Silber, M.D.

    Maccabi Healthcare Services, Israel

    PRINCIPAL INVESTIGATOR

  • Ofra Kalter-Leibovici, M.D.

    Sheba Medical Center

    PRINCIPAL INVESTIGATOR

  • Galit Kaufman, RN

    Sheba Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Ofra Kalter-Leibovici

Study Record Dates

First Submitted

September 20, 2007

First Posted

September 21, 2007

Study Start

August 1, 2007

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

April 5, 2019

Record last verified: 2019-04

Locations

IL(1)