Clinical trial NCT00311194: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Heart failure
Education
CD-ROM
Randomization
Hospitalization
Readmission
Death
Knowledge
Lead sponsor: Swedish Heart Lung Foundation
Sponsor class: OTHER
Collaborators: name: The Council for Medical Health Care Research in South Sweden
name: The Malmö University Hospital Research and Development Foundation
name: The Skane County Councils Research and Development Foundation
name: The NEPI Foundation
First posted: 2006-04-05
Enrollment: 206
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: ECT

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.

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.

Primary outcomes:
measure: Readmission and death rate at 6 months' follow up.
Secondary outcomes:
measure: Knowledge regarding heart failure and its treatment
Other outcomes:
Locations:
city: Malmo
country: Sweden
facility: Drug and Therapeutics Committee, Malmoe University Hospital
Study officials:
affiliation: Drug and Therapeutics Committee
name: Hans Liedholm, MD, PhD
role: STUDY_DIRECTOR
affiliation: Drug and Therapeutics Committee
name: Agneta Björck Linné, B Pharm, PhD
role: STUDY_CHAIR
References:
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.
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.
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.