HINCAB-study. Home Based Intervention in Nursing for Coronary Artery Bypass Patients
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|ClinicalTrials.gov Identifier: NCT00245817|
Recruitment Status : Completed
First Posted : October 28, 2005
Last Update Posted : March 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Anxiety Depression||Behavioral: HINCAB||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||203 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Coronary Artery Bypass Grafting (CABG) Patients in the Rehabilitation Phase. A Randomised Controlled Trial.|
|Study Start Date :||August 2003|
|Actual Primary Completion Date :||January 2005|
|Actual Study Completion Date :||July 2005|
- Anxiety and depression symptoms [ Time Frame: 6 months ]
- Health related quality of life [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|