NCT00311194

Brief Summary

The purpose of this study is to determine whether extra education of patients with chronic heart failure can reduce 6 months readmission rate to hospital.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
206

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Feb 1998

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

February 1, 1998

Completed
4.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2002

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
Last Updated

April 5, 2006

Status Verified

May 1, 2002

First QC Date

April 3, 2006

Last Update Submit

April 3, 2006

Conditions

Keywords

Heart failureEducationCD-ROMRandomizationHospitalizationReadmissionDeathKnowledge

Outcome Measures

Primary Outcomes (1)

  • Readmission and death rate at 6 months' follow up.

Secondary Outcomes (1)

  • Knowledge regarding heart failure and its treatment

Interventions

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Inpatients treated for heart failure with left ventricular ejection fraction (LVEF) \< 40 % at echocardiography or at least two of the criteria pulmonary rates, peripheral oedema, a third heart sound and signs of heart failure at chest X-ray.

You may not qualify if:

  • Somatic disease or physical handicap with difficulties to communicate or handle the technical equipment, patients with only little knowledge in Swedish, patients with expected problems with compliance due to alcohol/drug abuse or major psychiatric illness, and participation in a trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drug and Therapeutics Committee, Malmoe University Hospital

Malmo, S-205 02, Sweden

Location

Related Publications (3)

  • Liedholm H, Linne AB, Agelii L. The development of an interactive education program for heart failure patients: the Kodak Photo CD Portfolio concept. Patient Educ Couns. 1996 Nov;29(2):199-206. doi: 10.1016/0738-3991(96)00902-0.

    PMID: 9006236BACKGROUND
  • Linne AB, Liedholm H, Israelsson B. Effects of systematic education on heart failure patients' knowledge after 6 months. A randomised, controlled trial. Eur J Heart Fail. 1999 Aug;1(3):219-27. doi: 10.1016/s1388-9842(99)00041-0.

    PMID: 10935668BACKGROUND
  • Linne AB, Liedholm H. Effects of an interactive CD-program on 6 months readmission rate in patients with heart failure - a randomised, controlled trial [NCT00311194]. BMC Cardiovasc Disord. 2006 Jun 24;6:30. doi: 10.1186/1471-2261-6-30.

MeSH Terms

Conditions

Heart FailureDeath

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Hans Liedholm, MD, PhD

    Drug and Therapeutics Committee

    STUDY DIRECTOR
  • Agneta Björck Linné, B Pharm, PhD

    Drug and Therapeutics Committee

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
ECT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 5, 2006

Study Start

February 1, 1998

Study Completion

July 1, 2002

Last Updated

April 5, 2006

Record last verified: 2002-05

Locations