Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure

This study has been completed.
Sponsor:
Collaborators:
The Council for Medical Health Care Research in South Sweden
The Malmö University Hospital Research and Development Foundation
The Skane County Councils Research and Development Foundation
The NEPI Foundation
Information provided by:
Swedish Heart Lung Foundation
ClinicalTrials.gov Identifier:
NCT00311194
First received: April 3, 2006
Last updated: NA
Last verified: May 2002
History: No changes posted
  Purpose

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.


Condition Intervention
Heart Failure
Behavioral: 6 months readmission rate to hospital

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Official Title: A Randomised, Controlled Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure

Resource links provided by NLM:


Further study details as provided by Swedish Heart Lung Foundation:

Primary Outcome Measures:
  • Readmission and death rate at 6 months' follow up.

Secondary Outcome Measures:
  • Knowledge regarding heart failure and its treatment

Estimated Enrollment: 206
Study Start Date: February 1998
Estimated Study Completion Date: July 2002
Detailed Description:

The prevalence of heart failure (HF) has increased in the western world and is a major concern due to increasing prevalence and rising health care costs. The prognosis remains poor despite improvement in survival due to treatment with ACE-inhibitors and beta-receptor antagonists. HF has a high rate of readmission and hospitalisation. Some readmissions are ascribed to patients’ lack of compliance, insufficient knowledge about diet, medication and symptoms of heart failure. Education of patients has become an important component in order to increase the patients’ self-care and compliance. Intense education and counselling of patients is recommended in both European and American guidelines for HF.

Several systematic reviews of studies on strategies for improvement of outcomes of heart failure patients after discharge have been published, but very little emphasis has been put on methodological issues, e.g. methods of education. In most programs the methods and equipment used for education and information have only consisted of verbal and written material; computer-based tools seem to be relatively new.

Interactive CD-ROM programs for HF patients can increase patients’ knowledge about heart failure and its treatment. However, no studies have examined the clinical outcome, e.g. rate of readmission.

Comparison: Extra educated patients (interactive CD-ROM education) compared to standard educated patients on readmission rate or death during 6 months.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00311194

Locations
Sweden
Drug and Therapeutics Committee, Malmoe University Hospital
Malmo, Sweden, S-205 02
Sponsors and Collaborators
Swedish Heart Lung Foundation
The Council for Medical Health Care Research in South Sweden
The Malmö University Hospital Research and Development Foundation
The Skane County Councils Research and Development Foundation
The NEPI Foundation
Investigators
Study Director: Hans Liedholm, MD, PhD Drug and Therapeutics Committee
Study Chair: Agneta Björck Linné, B Pharm, PhD Drug and Therapeutics Committee
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00311194     History of Changes
Other Study ID Numbers: ABLM
Study First Received: April 3, 2006
Last Updated: April 3, 2006
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by Swedish Heart Lung Foundation:
Heart failure
Education
CD-ROM
Randomization
Hospitalization
Readmission
Death
Knowledge

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 26, 2014