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

NCT ID: NCT00311194

Last Updated: 2006-04-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

206 participants

Study Classification

INTERVENTIONAL

Study Start Date

1998-02-28

Study Completion Date

2002-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

ECT

Blinding Strategy

NONE

Interventions

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6 months readmission rate to hospital

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

0 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Council for Medical Health Care Research in South Sweden

UNKNOWN

Sponsor Role collaborator

The Malmö University Hospital Research and Development Foundation

UNKNOWN

Sponsor Role collaborator

The Skane County Councils Research and Development Foundation

UNKNOWN

Sponsor Role collaborator

The NEPI Foundation

UNKNOWN

Sponsor Role collaborator

Swedish Heart Lung Foundation

OTHER

Sponsor Role lead

Principal Investigators

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Hans Liedholm, MD, PhD

Role: STUDY_DIRECTOR

Drug and Therapeutics Committee

Agneta Björck Linné, B Pharm, PhD

Role: STUDY_CHAIR

Drug and Therapeutics Committee

Locations

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Drug and Therapeutics Committee, Malmoe University Hospital

Malmo, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 9006236 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10935668 (View on PubMed)

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.

Reference Type DERIVED
PMID: 16796760 (View on PubMed)

Other Identifiers

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ABLM

Identifier Type: -

Identifier Source: org_study_id