What Are the Expectations for Future Examination and Treatment in Patients Undergoing Evaluation and Treatment of Coronary Heart Disease?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 754
- Locations
- 1
Study Overview
Brief Summary
Aim: To investigate and compare women's and men's expectations before investigation and treatment of suspected coronary artery disease and to examine how these expectations are met.
Do women and men, of different ages, have the same expectations for the evaluation and treatment of stable coronary artery disease and are their expectations met in a equal degree?
Are there differences in expectations and the fulfilment of these according to age and other clinical history variables? Do the findings in the specially developed questionnaire designed to gather patients' expectations to the outcome on quality of life and degree of angina pectoris relate to their appearance in the designated forms? Is there a relationship between NTproBNP - levels, as a measure of cardiac workload, and expectations and the fulfilment of these as well as the quality of life and degree of angina pectoris?
Method: Patients will be asked to participate in the study, in the context of medical consultation before coronary angiography by a physician and / or a study nurse. This occurs during an outpatient visit at the cardiac clinic at the respective centre. Included are all patients planned for elective coronary angiography before possible revascularization during a eight month period regardless of diagnosis. Including are four hospitals in the region of Västra Götaland.
Detailed Description
Patients will be asked to participate in the study, in the context of medical consultation before coronary angiography by a physician and / or a study nurse. This occurs during an outpatient visit at the cardiac clinic at the respective centre.
Included are all patients planned for elective coronary angiography before possible revascularization during a eight month period at SKAS, NÄL, SÄS and Sahlgrenska University Hospital, this regardless of diagnosis.
Patient informed consent (attached appendix) is given to the patient before coronary angiography at the out patient visit at the cardiac clinic at the respective centre, both verbally and in writing by physician and/or nurse at the time of consultation about participation in the study. At this time the approval is signed by concerned parties. This is desired to be done only by a nurse as there is no intervention in the study. The patient has to fill out three questionnaires at two occasions (but the 10 first patients included in the reliability tests have to fill out the expectancy form a total of three times including questions about the reliability of the questionnaire). The patient also has to leave two additional blood samples.
Patients answer a questionnaire developed to measure the expectations of treatment and questionnaires measuring quality of life and presence and degree of angina pectoris, (SF-36 and SAQ Seattle Angina Questionnaire). The form of expectations is validated against the "quality of life" forms. Blood samples are taken at inclusion and again after six months and are analyzed for NTproBNP, a biochemical measure of how much strain the coronary artery disease puts on the heart muscle. We want to examine whether levels of NTproBNP before and six months after coronary angiography correlates with quality of life and expectations before the inquiry and to what extent the expectations are met. To ensure equal treatment, it is important to build a patient perspective and set offered treatment and the availability of this, in relation to the individual patient's expectations.
The following three instruments will be used to measure symptoms, functional limitation, and expectations:
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •<18 Years of Age.
Exclusion Criteria
- •Inability to communicate verbally or in writing.
- •Unwillingness to participate in the study.