NCT01234753

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
114

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2006

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2010

Completed
Last Updated

November 4, 2010

Status Verified

January 1, 2009

Enrollment Period

4.5 years

First QC Date

November 3, 2010

Last Update Submit

November 3, 2010

Conditions

Adults With Congenitally Malformed Hearts

Keywords

Adults with CHDGUCHCongenital heart diseaseComputer-based educationNursing

Study Arms (1)

Usulal care

NO INTERVENTION

Usual care by a visit to physician at the hospital out-patient clinic

Other: Physician and nurse consultation

Interventions

Physician and nurse consultationOTHER

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.

Usulal care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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),

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Defects, Congenital

Interventions

Physicians

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 3, 2010

First Posted

November 4, 2010

Study Start

May 1, 2006

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

November 4, 2010

Record last verified: 2009-01