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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety, Depression

Intervention / Treatment
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* Behavioral: HINCAB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: HINCAB|Psycho-educative intervention performed 2 and 4 weeks after surgery|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety and depression symptoms |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health related quality of life |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anxiety. Depression. HRQOL. Psycho-educative intervention