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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00311194
• Other study ID #: ABLM
• Status: Completed
• Phase: N/A
• First received: April 3, 2006
• Last updated: April 3, 2006
• Start date: February 1998
• Est. completion date: July 2002

Study information

• Verified date: May 2002
• Source: Swedish Heart Lung Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: July 2002
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Educational/Counseling/Training

Related Conditions & MeSH terms

• Heart Failure

Intervention

Behavioral:
• 6 months readmission rate to hospital

Locations

Country	Name	City	State
Sweden	Drug and Therapeutics Committee, Malmoe University Hospital	Malmo

Sponsors (5)

Lead Sponsor	Collaborator
Swedish Heart Lung Foundation	The Council for Medical Health Care Research in South Sweden, The Malmö University Hospital Research and Development Foundation, The NEPI Foundation, The Skane County Councils Research and Development Foundation

Country where clinical trial is conducted

Sweden, 

References & Publications (2)

Liedholm H, Linné AB, Agélii 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. — View Citation

Linné 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Readmission and death rate at 6 months' follow up.
Secondary	Knowledge regarding heart failure and its treatment