AnxietyNCT00245817
HINCAB-study. Home Based Intervention in Nursing for Coronary Artery Bypass Patients
A study testing HINCAB in people with Anxiety and Depression, run by Ullevaal University Hospital at 1 site in Norway.
Trial summary
HINCAB-study is a single senter, prospective, randomised controlled trial. The aim of the study is to test the effect of a home based intervention program. The hypothesis of the study is that a home based intervention will influencing coping strategies in the CABG-patients rehabilitation phase, reduce symptoms and… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anxiety, Depression
- What is being tested?
- HINCAB
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 203 participants
- Where
- 1 siteNorway
- Study dates
- Aug 2003to Jul 2005
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: Elective CABG-patients admitted to Ullevål University Hospital. The patients must be capable, physical and mental to fill in all questionnaires. In addition, to be capable to read and understand Norwegian. Driving distance maximum three hours each way.
Exclusion Criteria: Patients with combined surgery (coronary- and valve replacement surgery). Emergency surgery. Redo. Patients that related to surgery experience cerebral insult, mediastinitis or become intensive care patients will be excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Coronary Artery Bypass Grafting (CABG) Patients in the Rehabilitation Phase. A Randomised Controlled Trial.
HINCAB-study is a single senter, prospective, randomised controlled trial. The aim of the study is to test the effect of a home based intervention program. The hypothesis of the study is that a home based intervention will influencing coping strategies in the CABG-patients rehabilitation phase, reduce symptoms and improve health related quality of life.
Read the detailed description
Research has shown better quality of life for patients after CABG. At the same point of time studies shows that patients experience anxiety and depression years after surgery. Anxiety and depression appear frequently at the same time and strengthen each other. Studies underline that CABG-patients especially the first month after surgery want follow-up by health care provider. Anxiety and depression are assessed as independent risk factors for morbidity and death in heart patients.
203 CABG-patients were randomised into the study. Both patient group, the experimental- and control group, answered the same three standardised questionnaires before surgery, 6 weeks and 6 months after surgery. The questionnaires are Hospital Anxiety and Depression Scale (HADS), Seattle Angina Questionnaire (SAQ) and SF-36.
The intervention consist of two home visits 2 and 4 weeks after CABG undertaken by project leader. The intervention protocol has been approved by The Norwegian Committee for Medical Research Ethics.
Knowledge from this study may generate a basis for clinical guidelines and patient pathways. Results from this study will show if the home based intervention in the future will be performed for only a risk group of about 20 % that have responded best to the intervention. In the future the intervention also may be individualized electronically.
- Conditions
- Anxiety, Depression
- Being tested
- HINCAB
- Keywords
- Anxiety. Depression. HRQOL. Psycho-educative intervention
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HINCABBehavioural
Psycho-educative intervention performed 2 and 4 weeks after surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and depression symptoms
Measured: 6 months
Secondary outcomes (1)
Health related quality of life
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2005 (estimated)
- Study startAug 2003
- Primary completionJan 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ullevaal University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Irene Lie, PhD student, Principal investigator, Ullevaal University HospitalEli H Bunch, Professor, Study chair, Institute of Nursing and Health Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00245817
- Sponsor's protocol ID
- HINCAB
- Status last verified
- Dec 2010
- First submitted
- 27 Oct 2005
- Last updated
- 11 Mar 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch EH. Health-related quality of life after coronary artery bypass grafting. The impact of a randomised controlled home-based intervention program. Qual Life Res. 2009 Mar;18(2):201-7. doi: 10.1007/s11136-008-9438-y. Epub 2009 Jan 25.
PubMed 19169899Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch EH. Effects of a home-based intervention program on anxiety and depression 6 months after coronary artery bypass grafting: a randomized controlled trial. J Psychosom Res. 2007 Apr;62(4):411-8. doi: 10.1016/j.jpsychores.2006.11.010.
PubMed 17383492Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch EH. Predictors for physical and mental health 6 months after coronary artery bypass grafting: a cohort study. Eur J Cardiovasc Nurs. 2010 Dec;9(4):238-43. doi: 10.1016/j.ejcnurse.2010.02.001. Epub 2010 Mar 9.
PubMed 20219433Lie I, Bunch EH, Smeby NA, Arnesen H, Hamilton G. Patients' experiences with symptoms and needs in the early rehabilitation phase after coronary artery bypass grafting. Eur J Cardiovasc Nurs. 2012 Mar;11(1):14-24. doi: 10.1016/j.ejcnurse.2010.09.004.
PubMed 21030311
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Artery Bypass Grafting (CABG) Patients in the Rehabilitation Phase. A Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT00245817
- Acronym / sponsor ID
- HINCAB
- Conditions
- Anxiety, Depression
- Keywords
- Anxiety. Depression. HRQOL. Psycho-educative intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Ullevaal University HospitalUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jan 2005 (actual)
- Study completion
- Jul 2005 (actual)
- First posted
- 28 Oct 2005 (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.
HINCAB-study is a single senter, prospective, randomised controlled trial. The aim of the study is to test the effect of a home based intervention program. The hypothesis of the study is that a home based intervention will influencing coping strategies in the CABG-patients rehabilitation phase, reduce symptoms and improve health related quality of life.
Detailed description
Research has shown better quality of life for patients after CABG. At the same point of time studies shows that patients experience anxiety and depression years after surgery. Anxiety and depression appear frequently at the same time and strengthen each other. Studies underline that CABG-patients especially the first month after surgery want follow-up by health care provider. Anxiety and depression are assessed as independent risk factors for morbidity and death in heart patients.
203 CABG-patients were randomised into the study. Both patient group, the experimental- and control group, answered the same three standardised questionnaires before surgery, 6 weeks and 6 months after surgery. The questionnaires are Hospital Anxiety and Depression Scale (HADS), Seattle Angina Questionnaire (SAQ) and SF-36.
The intervention consist of two home visits 2 and 4 weeks after CABG undertaken by project leader. The intervention protocol has been approved by The Norwegian Committee for Medical Research Ethics.
Knowledge from this study may generate a basis for clinical guidelines and patient pathways. Results from this study will show if the home based intervention in the future will be performed for only a risk group of about 20 % that have responded best to the intervention. In the future the intervention also may be individualized electronically.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| HINCABPsycho-educative intervention performed 2 and 4 weeks after surgery | Behavioural | – |
Primary outcome
Anxiety and depression symptoms
Time frame: 6 months
1 secondary outcome
Health related quality of life
Time frame: 6 months
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 11 Mar 2011.
- Results publication: PubMed 19169899Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch EH. Health-related quality of life after coronary artery bypass grafting. The impact of a randomised controlled home-based intervention program. Qual Life Res. 2009 Mar;18(2):201-7. doi: 10.1007/s11136-008-9438-y. Epub 2009 Jan 25.
- Results publication: PubMed 17383492Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch EH. Effects of a home-based intervention program on anxiety and depression 6 months after coronary artery bypass grafting: a randomized controlled trial. J Psychosom Res. 2007 Apr;62(4):411-8. doi: 10.1016/j.jpsychores.2006.11.010.
- Results publication: PubMed 20219433Lie I, Arnesen H, Sandvik L, Hamilton G, Bunch EH. Predictors for physical and mental health 6 months after coronary artery bypass grafting: a cohort study. Eur J Cardiovasc Nurs. 2010 Dec;9(4):238-43. doi: 10.1016/j.ejcnurse.2010.02.001. Epub 2010 Mar 9.
- Results publication: PubMed 21030311Lie I, Bunch EH, Smeby NA, Arnesen H, Hamilton G. Patients' experiences with symptoms and needs in the early rehabilitation phase after coronary artery bypass grafting. Eur J Cardiovasc Nurs. 2012 Mar;11(1):14-24. doi: 10.1016/j.ejcnurse.2010.09.004.
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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.
Irene Lie, PhD student principal investigator
Ullevaal University Hospital
Eli H Bunch, Professor study chair
Institute of Nursing and Health Science
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HINCAB in people with Anxiety and Depression, run by Ullevaal University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 11 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does the primary outcome measure?
Anxiety and depression symptoms (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00245817, which also lists 4 linked publications.
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 11 Mar 2011.