ClinicalTrials.gov
ClinicalTrials.gov Menu

Follow up of Adults With Congenitally Malformed Hearts With Focus on Computer-Based Education and Psychosocial Support

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01234753
Recruitment Status : Completed
First Posted : November 4, 2010
Last Update Posted : November 4, 2010
Sponsor:
Collaborators:
Ryhov County Hospital
Kalmar County Hospital
Skane University Hospital
Information provided by:
University Hospital, Linkoeping

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.


Condition or disease Intervention/treatment Phase
Adults With Congenitally Malformed Hearts Other: Physician and nurse consultation Not Applicable

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

  • 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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Care Provider)
Primary Purpose: Supportive Care
Official Title: Follow up of Adults With Congenitally Malformed Hearts With Focus on Computer-Based Education and Psychosocial Support
Study Start Date : May 2006
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

Arm Intervention/treatment
No Intervention: Usulal care
Usual care by a visit to physician at the hospital out-patient clinic
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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Helén Rönning, Department of Cardiology, Linköping University Hospital
ClinicalTrials.gov Identifier: NCT01234753     History of Changes
Other Study ID Numbers: SSKGUCH-1
M172-05 ( Other Identifier: Regional Ethical Review Bords/Central Ethical Review Board )
First Posted: November 4, 2010    Key Record Dates
Last Update Posted: November 4, 2010
Last Verified: January 2009

Keywords provided by University Hospital, Linkoeping:
Adults with CHD
GUCH
Congenital heart disease
Computer-based education
Nursing