Follow up of Adults With Congenitally Malformed Hearts With Focus on Computer-Based Education and Psychosocial Support
| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 2010 |
| Last Updated Date | November 3, 2010 |
| Start Date ICMJE | May 2006 |
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE | Not Provided |
| Original Primary Outcome Measures ICMJE | Not Provided |
| Change History | No Changes Posted |
| Current Secondary Outcome Measures ICMJE | Not Provided |
| Original Secondary Outcome Measures ICMJE | Not Provided |
| Current Other Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | Not Provided |
| Descriptive Information | |
| Brief Title ICMJE | Follow up of Adults With Congenitally Malformed Hearts With Focus on Computer-Based Education and Psychosocial Support |
| Official Title ICMJE | Follow up of Adults With Congenitally Malformed Hearts With Focus on Computer-Based Education and Psychosocial Support |
| Brief Summary | The number of adults with congenitally malformed hearts is increasing. According to a prospective population-based cohort study from Sweden (1992-2001) the prevalence of cardiovascular defects was 9.1 per 1,000 births, which is comparable to other presented prevalence data in the world.On the basis of 9 million inhabitants, Sweden should have approximately 82000 born with CHD and approximately 20000 will, in adult age, need regular follow up in cardiac care. This is a result of the greater improvements within paediatric heart surgery and there is an increasing demand for continuous follow up in the healthcare system.[2] Guidelines from the European Society of Cardiology and the Canadian Cardiovascular Society recommend follow-up oriented towards both medical and psychosocial problems. Earlier studies have shown that adults with CHD have poor knowledge about their heart disease.The results are difficult to summarise because of the use of different instruments, methods and sample sizes. Most of the adults with CHD did not know their clinical diagnosis or what endocarditis was. However, we do not know if everyone in these studies was recommended endocarditis prophylactics or their definition of poor knowledge. At present different programmes for adults with CHD are established in hospital outpatient clinics. These studies describe the established programmes. They also address the needs for development of care e.g. a multicenter approach, transitions from paediatric to adult health care, delivery care in Europe, programmes for pregnancy, how to provide clinical strategies, health care resource utilization or outpatient nursing clinic for adults with CHD. But there is a lack of knowledge regarding how education and psychosocial support should be given to adults with congenitally malformed hearts and what effects that can be achieved. The aim is to evaluate the effects of a nurse-led intervention consisting of education by a computer-based educational programme and psychosocial support to adults with congenitally malformed hearts. |
| Detailed Description | Sample: 114 adults with congenitally malformed hearts as ventricular septal defect, atrial septal defect, coarctation of the aortae, tetralogy of Fallot, complete transposition of the great arteries, congenitally corrected transposition of the great arteries, single ventricle, Ebstein anomaly, coarctation of the aortae, Eisenmenger syndrome and aortic valve stenosis. Method and Measures: Randomised, controlled study where. the iIntervention-group will receive medical consultation, nurse consultation with psychosocial support, verbal and computer-based education. A care-plan with individual goals will be developed for each individual. Follow up of the care plan will be conducted after 1 month. The Control-group will receive: standard care with medical consultation. Data will be collected at baseline and after 3 and 12 months. Instruments
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| Study Type ICMJE | Interventional |
| Study Phase | Not Provided |
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Caregiver) Primary Purpose: Supportive Care |
| Condition ICMJE | Adults With Congenitally Malformed Hearts |
| Intervention ICMJE | Other: Physician and nurse consultation
Usual care by a visit to physician at the hospital out-patient clinic and computer-based and individual education and psychosocial support by a nurse-led session. |
| Study Arm (s) | No Intervention: Usulal care
Usual care by a visit to physician at the hospital out-patient clinic
Intervention: Other: Physician and nurse consultation |
| Publications * | Not Provided |
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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 | 114 |
| Completion Date | November 2010 |
| Primary Completion Date | November 2010 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 18 Years and older |
| Accepts Healthy Volunteers | No |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Not Provided |
| Administrative Information | |
| NCT Number ICMJE | NCT01234753 |
| Other Study ID Numbers ICMJE | SSKGUCH-1, M172-05 |
| Has Data Monitoring Committee | No |
| Responsible Party | Helén Rönning, Department of Cardiology, Linköping University Hospital |
| Study Sponsor ICMJE | University Hospital, Linkoeping |
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided |
| Information Provided By | University Hospital, Linkoeping |
| Verification Date | January 2009 |
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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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