- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT01234753
Follow up of Adults With Congenitally Malformed Hearts With Focus on Computer-Based Education and Psychosocial Support
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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
- Knowledge instrument developed in Belgium , translated, further developed, tested in study 3. Now further reliability and validity tests in this study 4.
- Health related quality of life, Short Form 36 (SF-36). SF-36 has good validity and reliability and is adjust to Swedish circumstances • Anxiety and depression, Hospital Anxiety and Depression Scale, (HADS)
- General health related quality of life, Euroqol 5 dimensions (EQ-5D)
- Perceived control
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
- adults with uncomplicated congenitally malformed hearts (ventricular septal defect, atrial septal defect, coarctation of the aortae, aortic valve stenosis) and complicated congenitally malformed hearts (tetralogy of Fallot, complete transposition of the great arteries, congenitally corrected transposition of the great arteries, Ebstein anomaly and Eisenmenger syndrome),
Exclusion Criteria:
- complicating serious co-morbidity such as hereditary heart diseases (age-related coronary heart diseases, valve diseases), other diseases or life-threatening diseases, psychiatric illness or inability to read or understand Swedish.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Inget ingripande: Usulal care
Usual care by a visit to physician at the hospital out-patient clinic
|
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.
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- SSKGUCH-1
- M172-05 (Annan identifierare: Regional Ethical Review Bords/Central Ethical Review Board)
Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .
Kliniska prövningar på Physician and nurse consultation
-
Memorial Sloan Kettering Cancer CenterAvslutadLymfom | Benmärgstransplantation | GI Cancer | GU CancerFörenta staterna