Heart FailureNCT00311194
Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure
A study testing 6 months readmission rate to hospital in people with Heart Failure, run by Swedish Heart Lung Foundation at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 0 years and olderHealthy volunteers can take part
- Conditions the study is for
- Heart Failure
- What is being tested?
- 6 months readmission rate to hospital
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 206 participants
- Where
- 1 siteSweden
- Study dates
- Feb 1998to Jul 2002
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Drug and Therapeutics Committee, Malmoe University Hospital
Malmö, S-205 02
About this study
Official title: A Randomised, Controlled Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- 6 months readmission rate to hospital
- Keywords
- Heart failure, Education, CD-ROM, Randomization, Hospitalization, Readmission, Death, Knowledge
- Medical subject headings
- Heart Failure, Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 months readmission rate to hospitalBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Readmission and death rate at 6 months' follow up.
Secondary outcomes (1)
Knowledge regarding heart failure and its treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2006 (estimated)
- Study startFeb 1998
- Study completionJul 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 206 participants
Sponsor and investigators
- Lead sponsor
- Swedish Heart Lung Foundation
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Hans Liedholm, MD, PhD, Study director, Drug and Therapeutics CommitteeAgneta Björck Linné, B Pharm, PhD, Study chair, Drug and Therapeutics Committee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00311194
- Sponsor's protocol ID
- ABLM
- Status last verified
- May 2002
- First submitted
- 3 Apr 2006
- Last updated
- 5 Apr 2006
- Results posted
- No
Publications
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.
PubMed 9006236Linne 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.
PubMed 10935668Linne 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.
PubMed 16796760
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Controlled Trial of an Interactive CD-Program on 6 Months Readmission Rate in Patients With Heart Failure
- ClinicalTrials.gov ID
- NCT00311194
- Acronym / sponsor ID
- ABLM
- Conditions
- Heart Failure
- Keywords
- Heart failure, Education, CD-ROM, Randomization, Hospitalization, Readmission, Death, Knowledge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 206 participants
- Lead sponsor
- Swedish Heart Lung FoundationUniversity, hospital or other
- 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
- Study start
- Feb 1998
- Study completion
- Jul 2002
- First posted
- 5 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Early clinical test
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 0 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6 months readmission rate to hospital | Behavioural | – |
Primary outcome
Readmission and death rate at 6 months' follow up.
1 secondary outcome
Knowledge regarding heart failure and its treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2006.
- Background: PubMed 9006236Liedholm 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.
- Background: PubMed 10935668Linne 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.
- Derived from this study: PubMed 16796760Linne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hans Liedholm, MD, PhD study director
Drug and Therapeutics Committee
Agneta Björck Linné, B Pharm, PhD study chair
Drug and Therapeutics Committee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 months readmission rate to hospital in people with Heart Failure, run by Swedish Heart Lung Foundation at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readmission and death rate at 6 months' follow up.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00311194, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2006.