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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
Sponsor:
Information provided by:
Oslo University Hospital

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.

Condition or disease Intervention/treatment Phase
Anxiety Depression Behavioral: HINCAB Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 203 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources


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


Primary Outcome Measures :
  1. Anxiety and depression symptoms [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. Health related quality of life [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

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


Locations
Norway
Ullevål University Hospital
Oslo, Norway
Sponsors and Collaborators
Ullevaal University Hospital
Investigators
Principal Investigator: Irene Lie, PhD student Ullevaal University Hospital
Study Chair: Eli H Bunch, Professor Institute of Nursing and Health Science

Publications of Results:
Responsible Party: Principal investigator: Irene Lie, PhD student, Ullevaal University Hospital
ClinicalTrials.gov Identifier: NCT00245817     History of Changes
Other Study ID Numbers: HINCAB
First Posted: October 28, 2005    Key Record Dates
Last Update Posted: March 11, 2011
Last Verified: December 2010

Keywords provided by Oslo University Hospital:
Anxiety. Depression. HRQOL. Psycho-educative intervention

Additional relevant MeSH terms:
Depression
Behavioral Symptoms