Adults With Congenitally Malformed HeartsNCT01234753
Follow up of Adults With Congenitally Malformed Hearts With Focus on Computer-Based Education and Psychosocial Support
A study testing Physician and nurse consultation in people with Adults With Congenitally Malformed Hearts, run by University Hospital, Linkoeping.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adults With Congenitally Malformed Hearts
- What is being tested?
- Physician and nurse consultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 114 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Nov 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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),
Who cannot join
- 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.
About this study
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.
Read the 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
- Being tested
- Physician and nurse consultation
- Keywords
- Adults with CHD, GUCH, Congenital heart disease, Computer-based education, Nursing
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Usulal care | No intervention | Usual care by a visit to physician at the hospital out-patient clinic Receives: Other: Physician and nurse consultation |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2010 (estimated)
- Study startMay 2006
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults With Congenitally Malformed HeartsStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 114 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Collaborators
- Ryhov County Hospital, Kalmar County Hospital, Skane University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01234753
- Sponsor's protocol ID
- SSKGUCH-1
- Other IDs
- M172-05
- Status last verified
- Jan 2009
- First submitted
- 3 Nov 2010
- Last updated
- 4 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Follow up of Adults With Congenitally Malformed Hearts With Focus on Computer-Based Education and Psychosocial Support
- ClinicalTrials.gov ID
- NCT01234753
- Acronym / sponsor ID
- SSKGUCH-1
- Keywords
- Adults with CHD, GUCH, Congenital heart disease, Computer-based education, Nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 114 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Collaborators
- Ryhov County Hospital, Kalmar County Hospital, Skane University Hospital
- Study start
- May 2006
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Nov 2010 (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 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
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Usulal care | No intervention | Other: Physician and nurse consultationUsual care by a visit to physician at the hospital out-patient clinic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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),
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| Physician and nurse consultationUsual 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. | Other | Usulal care |
Primary outcome
Not reported in the source record.
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 4 Nov 2010.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Physician and nurse consultation in people with Adults With Congenitally Malformed Hearts, run by University Hospital, Linkoeping.
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 4 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
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.
Where can I read the original study information?
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 4 Nov 2010.