Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure
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| First Received Date ICMJE | April 3, 2006 | ||||||||
| Last Updated Date | April 3, 2006 | ||||||||
| Start Date ICMJE | February 1998 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Current Primary Outcome Measures ICMJE |
Readmission and death rate at 6 months' follow up. | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Knowledge regarding heart failure and its treatment | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure | ||||||||
| Official Title ICMJE | A Randomised, Controlled Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure | ||||||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Educational/Counseling/Training |
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| Condition ICMJE | Heart Failure | ||||||||
| Intervention ICMJE | Behavioral: 6 months readmission rate to hospital | ||||||||
| Study Arm (s) | Not Provided | ||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 206 | ||||||||
| Completion Date | July 2002 | ||||||||
| Primary Completion Date | Not Provided | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Sweden | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00311194 | ||||||||
| Other Study ID Numbers ICMJE | ABLM | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Not Provided | ||||||||
| Study Sponsor ICMJE | Swedish Heart Lung Foundation | ||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Swedish Heart Lung Foundation | ||||||||
| Verification Date | May 2002 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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