In this study, the effect of a decision aid regarding the choice between watchful waiting or surgical treatment of AAA is explored, regarding decisional conflict, knowledge, satisfaction, quality of life, anxiety and clinical endpoints.
ID
Source
Brief title
Condition
- Vascular therapeutic procedures
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Decisional conflict
Secondary outcome
Knowledge
Satisfaction
Quality of life
Anxiety
Clinical enpoints (mortality, severe 30-day morbidity due to operation, rupture
during watchful waiting)
Background summary
Prevalence of the Abdominal Aortic Aneurysm (AAA) is 6% among the elderly male
population. AAA is an asymptomatic disease, but implies a risk of rupture of
the aneurysm. Whenever this occurs, the majority of patients will die due to
severe internal bleeding within 24 hours. An elective operation can prevent
rupture of the aneurysm, but may also induce mortality or severe morbidity due
to the very procedure.
For surgeons, the choice between the risk of rupture during watchful waiting,
or the risk of complications due to surgery is usually not clear-cut, mostly
due to comorbid conditions with the patient. Therefore, patient preferences are
of paramount importance.
A decision aid regarding treatment options for AAA could help patients and
surgeons to make an informed choice. Decision aids translate scientific
evidence regarding (the pro's and con's of) the treatment options into
comprehensible patient information. Moreover, patient preferences are elicited
in the decision aid. Previous research has shown that patients' decisional
conflict decreases, comprehension of treatment options increases, patients have
more realistic expectations and they are more actively participating in
decision making.
Study objective
In this study, the effect of a decision aid regarding the choice between
watchful waiting or surgical treatment of AAA is explored, regarding decisional
conflict, knowledge, satisfaction, quality of life, anxiety and clinical
endpoints.
Study design
Randomised clinical trial, in which 170 subjects are randomised between (1)
standard care and (2) standard care + decision aid
Intervention
Decision aid, comprising an interactive computer programme.
Study burden and risks
Because trial participation does not influence medical treatment, subjects will
suffer no (physical) risks. Subjects are requested to spend time to complete 5
questionnaires (with in total 70 items) at 4 points in time, from the first
visit to the outpatient clinic to 9 months after their treatment decision.
Subjects in the intervention arm might be frightened by the additional
information provided to them in the decision aid.
Meibergdreef 9
1100 DE
NL
Meibergdreef 9
1100 DE
NL
Listed location countries
Age
Inclusion criteria
1. Patients diagnosed with an AAA based on ultrasonography (and CT-scanning in the case of an aneurysm of 5.5 cm and more)
2. Age >18 years
3. Compos mentis
Exclusion criteria
1. life expectancy of <6 months
2. insufficient knowledge of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL24145.018.08 |