HINCAB-study. Home Based Intervention in Nursing for Coronary Artery Bypass Patients

Depression Clinical Trial

Official title:

Coronary Artery Bypass Grafting (CABG) Patients in the Rehabilitation Phase. A Randomised Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00245817
• Other study ID #: HINCAB
• Status: Completed
• Phase: N/A
• First received: October 27, 2005
• Last updated: March 10, 2011
• Start date: August 2003
• Est. completion date: July 2005

Study information

• Verified date: December 2010
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research Ethics
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: July 2005
• Est. primary completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Anxiety
• Depression

Intervention

Behavioral:
• HINCAB
Psycho-educative intervention performed 2 and 4 weeks after surgery

Locations

Country	Name	City	State
Norway	Ullevål University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (4)

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. — View 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/s11136-008-94 — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anxiety and depression symptoms		6 months	No
Secondary	Health related quality of life		6 months	No