Clinical trial NCT00245817: HINCAB-study. Home Based Intervention in Nursing for Coronary Artery Bypass Patients
Official title: Coronary Artery Bypass Grafting (CABG) Patients in the Rehabilitation Phase. A Randomised Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety
Depression
Keywords: Anxiety. Depression. HRQOL. Psycho-educative intervention
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2005-10-28
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety and depression symptoms
timeFrame: 6 months
Secondary outcomes:
measure: Health related quality of life
timeFrame: 6 months
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ullevål University Hospital
Study officials:
affiliation: Ullevaal University Hospital
name: Irene Lie, PhD student
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute of Nursing and Health Science
name: Eli H Bunch, Professor
role: STUDY_CHAIR
References:
citation: 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.
citation: Lie 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.
citation: Lie 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.
citation: Lie 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.