Clinical trial NCT05142280: Active Choice Regarding Cardiovascular Disease Risk
Official title: Actively Choosing How to Cope With an Increased Risk of Cardiovascular Disease: A Randomised Web-Based Experiment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiovascular Diseases
Keywords: Prevention
Active choice
Decision-making
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
First posted: 2021-12-02
Enrollment: 743
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Web-based randomized controlled trial
Primary purpose: PREVENTION

Brief summary: In this web-based RCT, the investigators will investigate whether promoting an active choice regarding coping with an increased CVD risk results in better psychological outcomes (e.g., degree of active choice; commitment toward the chosen option) compared to usual care (i.e., a GP's advice to change one's lifestyle and take medication). By 'active choice' the investigators mean a conscious and autonomous choice in which an individual (a) becomes aware of a discrepancy between the current and desired situation; (b) understands what his/her CVD risk means, and what its causes and consequences are; (c) evaluates the pros and cons of the different options to cope with the risk; and (d) is clear about his/her values regarding the choice. The different options to cope with an increased CVD risk include: changing one's lifestyle; taking medication; doing both; or changing nothing.

Detailed description: Cardiovascular disease (CVD) continues to be a leading cause of mortality among adults. Adults at increased risk of cardiovascular disease are usually advised by their general practitioner (GP) to change their lifestyle (i.e., quit smoking; eat healthier; become more physically active). In addition, GP's regularly advice their patients to take antihypertensive and/or lipid lowering medication to decrease the CVD risk. Previous research has shown that many patients at increased risk of CVD have difficulty maintaining lifestyle changes and adhering to their medication regimen - either intentionally or unintentionally. Intentional non-adherence could occur when patients experience side-effects of the medication, whereas unintentional non-adherence usually occurs when patients forget to take their medication.

In the current study, the investigators will investigate whether promoting an active choice regarding coping with an increased CVD risk results in better psychological outcomes (e.g., degree of active choice; commitment toward the chosen option) compared to usual care (i.e. a GP's advice to change one's lifestyle and take medication). By 'active choice' the investigators mean a conscious and autonomous choice in which an individual (a) becomes aware of a discrepancy between the current and desired situation; (b) understands what his/her CVD risk means, and what its causes and consequences are; (c) evaluates the pros and cons of the different options to cope with the risk; and (d) is clear about his/her values regarding the choice. The different options to cope with an increased CVD risk include: changing one's lifestyle; taking medication; doing both; or changing nothing.

The investigators will investigate this in a web-based RCT among adults aged 45-65 years. The intervention group (i.e. active choice group) and control group (i.e. usual care group) will both receive a hypothetical CVD risk. The investigators expect an active choice regarding coping with an increased CVD risk to result in better psychological outcomes compared to a GP's advice. Ultimately, a more active choice is expected to results in greater behavioural persistence regarding the chosen option; i.e. lifestyle change and/or medication adherence.

Eligibility criteria: Inclusion Criteria:

* Adults aged 45-65 years

Exclusion Criteria:

* Suffering/ having suffered from CVD
* Being on lipid lowering or blood pressure lowering medication
* Suffering from diabetes
* kidney damage or rheumatism
* not being able to walk at least 100 meters
* being in a wheelchair
* pregnancy

Primary outcomes:
measure: Active choice
timeFrame: Directly after the intervention
measure: Intention strength
timeFrame: Directly after the intervention
measure: Commitment
timeFrame: Directly after the intervention
Secondary outcomes:
measure: Intention
timeFrame: Directly after the intervention
measure: Self-efficacy
timeFrame: Directly after the intervention
measure: Response efficacy
timeFrame: Directly after the intervention
measure: Autonomous motivation subscale of the Treatment Motivation Questionnaire
timeFrame: Directly after the intervention
measure: Knowledge
timeFrame: Directly after the intervention
measure: Cognitive risk perception
timeFrame: Directly after the intervention
measure: Affective risk perception
timeFrame: Directly after the intervention
measure: Lifestyle change intention
timeFrame: Directly after the intervention
Other outcomes:
measure: Perceived Health according to the Research and Development 36
timeFrame: Directly after the intervention
measure: Control Preference Scale
timeFrame: Directly after the intervention
Locations:
city: Amsterdam
country: Netherlands
facility: VUMedicalCenter
state: Noord-Holland
Study officials:
affiliation: VU Medical Center, Amsterdam UMC
name: Danielle Timmermans, Prof
role: STUDY_DIRECTOR
References: