None listed
Conditions
Brief summary
The purpose of this study is to assess the effect of the 'Optimise' decision aid on choices regarding taking low dose aspirin for the prevention of cardiovascular disease and colorectal cancer. Who is it for? You may be eligible for this study if you are an adult aged 50-70 years who has not been diagnosed with a serious illness. Study details Participants will be recruited through their GP and randomised to one of two groups. All participants will complete a baseline questionnaire which involves individual risk calculations for cardiovascular disease and colorectal cancer. In one group patients will be taken through the 'Optimise' decision aid to consider the use of regular low-dose aspirin, weighing up the health benefits and the risk of side effects of aspirin, including gastrointestinal bleeding, along with personal preferences regarding taking aspirin. The other group (the control group) will receive general information about prevention of colorectal cancer. Participants will then be followed up after three months by telephone survey, including a measurement of informed choice regarding taking low - dose aspirin, and adherence to aspirin. They will also be followed up by SMS every 3 months for one year to assess adherence to aspirin. Patient data regarding health outcomes will be collected from health data sets for up to 10 years after enrolment. Outcomes It is hoped that the use of the Optimise decision aid will increase the proportion of participants making an informed choice about the use of aspirin to prevent cardiovascular disease and colorectal cancer.
Interventions
The Optimise study is an NHMRC funded double blinded randomised controlled clinical trial of a decision-aid tool regarding the use of aspirin to prevent both colorectal cancer and cardiovascular disease, while considering side effects such as gastrointestinal bleeding and patient preference regarding taking regular low dose aspirin.
The Optimise study will involve recruitment of patients aged 50-70 in general practice waiting rooms, and administering a personalised electronic decision–aid (on i
The Optimise study is an NHMRC funded double blinded randomised controlled clinical trial of a decision-aid tool regarding the use of aspirin to prevent both colorectal cancer and cardiovascular disease, while considering side effects such as gastrointestinal bleeding and patient preference regarding taking regular low dose aspirin. The Optimise study will involve recruitment of patients aged 50-70 in general practice waiting rooms, and administering a personalised electronic decision–aid (on iPad), regarding use of aspirin to the intervention group, and attention placebo to the control group. The intervention involves use of an an electronic decision aid which takes into account each participant's individual risk of cardiovascular disease and colorectal cancer, their personal risk of side effects such as gastrointestinal bleeding and their personal preferences regarding taking aspirin, and takes 5-10 minutes to administer at one occasion only. Results of the decision aid are given to the participant and to their general practitioner, and it is up to the participant to decide whether to take aspirin, following discussion with their general practitioner if they do so. Aspirin will not be included as part of the intervention.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
Adults aged 50-70, with access to email and SMS and ability to understand basic written English.
Exclusion criteria
Unable to understand basic written English Serious illness likely to impact on ability to participate Known serious illness likely to impact on life expectancy over the next 10 years Pregnant/ lactating women Under Guardianship orders/ Power of Attorney or Legal Guardian Cognitive or intellectual impairment not able to provide informed consent (as judged by qualified RN or GP – see above) Colorectal cancer Familial adenomatosis polyposis (FAP) Current dyspepsia Any history of peptic ulcer Untreated helicobacter pylori infection Aspirin allergy Bleeding diathesis Known increased risk of GI haemorrhage Anticoagulant therapy Antiplatelet therapy Chronic renal impairment Chronic liver disease Current symptoms of colorectal cancer, such as anaemia, change on bowel habit or weight loss for no reason. People with these symptoms should see their general practitioner as possible to discuss their symptoms.
Outcome results
None listed