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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00245817
Enrollment
203
Registered
2005-10-28
Start date
2003-08-31
Completion date
2005-07-31
Last updated
2011-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Depression

Keywords

Anxiety. Depression. HRQOL. Psycho-educative intervention

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.

Interventions

BEHAVIORALHINCAB

Psycho-educative intervention performed 2 and 4 weeks after surgery

Sponsors

Ullevaal University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Anxiety and depression symptoms6 months

Secondary

MeasureTime frame
Health related quality of life6 months

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026