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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
6 months readmission rate to hospital
Sponsored by
Swedish Heart Lung Foundation
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Heart Failure focused on measuring Heart failure, Education, CD-ROM, Randomization, Hospitalization, Readmission, Death, Knowledge

Eligibility Criteria

0 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Drug and Therapeutics Committee, Malmoe University Hospital

Outcomes

Primary Outcome Measures

Readmission and death rate at 6 months' follow up.

Secondary Outcome Measures

Knowledge regarding heart failure and its treatment

Full Information

First Posted
April 3, 2006
Last Updated
April 3, 2006
Sponsor
Swedish Heart Lung Foundation
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
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1. Study Identification

Unique Protocol Identification Number
NCT00311194
Brief Title
Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure
Official Title
A Randomised, Controlled Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
May 2002
Overall Recruitment Status
Completed
Study Start Date
February 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Swedish Heart Lung Foundation
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

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Heart failure, Education, CD-ROM, Randomization, Hospitalization, Readmission, Death, Knowledge

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
206 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
6 months readmission rate to hospital
Primary Outcome Measure Information:
Title
Readmission and death rate at 6 months' follow up.
Secondary Outcome Measure Information:
Title
Knowledge regarding heart failure and its treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Liedholm, MD, PhD
Organizational Affiliation
Drug and Therapeutics Committee
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Agneta Björck Linné, B Pharm, PhD
Organizational Affiliation
Drug and Therapeutics Committee
Official's Role
Study Chair
Facility Information:
Facility Name
Drug and Therapeutics Committee, Malmoe University Hospital
City
Malmo
ZIP/Postal Code
S-205 02
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
9006236
Citation
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.
Results Reference
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PubMed Identifier
10935668
Citation
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.
Results Reference
background
PubMed Identifier
16796760
Citation
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.
Results Reference
derived

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

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