Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00245817
Status:
COMPLETED
Last Update Posted:
2011-03-11
First Post:
2005-10-27
Brief Title:
HINCAB-study Home Based Intervention in Nursing for Coronary Artery Bypass Patients
Sponsor:
Ullevaal University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Coronary Artery Bypass Grafting CABG Patients in the Rehabilitation Phase A Randomised Controlled Trial
Status:
COMPLETED
Status Verified Date:
2010-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None