Depression Clinical Trial
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
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