HINCAB-study. Home Based Intervention in Nursing for Coronary Artery Bypass Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||Coronary Artery Bypass Grafting (CABG) Patients in the Rehabilitation Phase. A Randomised Controlled Trial.|
- Anxiety and depression symptoms [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Health related quality of life [ Time Frame: 6 months ] [ Designated as safety issue: No ]
|Study Start Date:||August 2003|
|Study Completion Date:||July 2005|
|Primary Completion Date:||January 2005 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00245817
|Ullevål University Hospital|
|Principal Investigator:||Irene Lie, PhD student||Ullevaal University Hospital|
|Study Chair:||Eli H Bunch, Professor||Institute of Nursing and Health Science|