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NCT05142280 | Not yet recruiting | Cardiovascular Diseases


Active Choice Regarding Cardiovascular Disease Risk
Sponsor:

VU University Medical Center

Information provided by (Responsible Party):

Lorraine Landais

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.

Condition or disease

Cardiovascular Diseases

Intervention/treatment

Decision-aid for cardiovascular disease risk

Control

Phase

Not Applicable

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.

Study Type : Interventional
Estimated Enrollment : 724 participants
Masking: Single
Masking Description: Participants do not know to which condition they are assigned
Primary Purpose: Prevention
Official Title: Actively Choosing How to Cope With an Increased Risk of Cardiovascular Disease: A Randomised Web-Based Experiment
Actual Study Start Date : January 2022
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022
Arm Intervention/treatment

Experimental: Active choice

This intervention contains information and an assignment to foster an active choice regarding coping with an increased CVD risk. Participants will be presented a hypothetical 'heart age' of 16 years older than their actual age. They will be asked to imagine that this heart age really applies to them. Next, participants will receive information about the meaning of the risk, including its causes and potential consequences, and about four coping strategies: changing one's lifestyle; taking medication; doing both; or changing nothing. The pros and cons of each strategy will be presented, followed by a value-clarification exercise.

Other: Decision-aid for cardiovascular disease risk

Other: Control

The control group will receive online information and advice that resembles GP's usual care. The information contains a hypothetical CVD risk: a risk of 31% to get CVD within 10 years. They will be asked to imagine that this risk really applies to them. Participants will read about an imaginary GP who advices to change one's lifestyle (i.e., quitting smoking; healthy diet; more physical activity), and to use medication to decrease the risk.

Other: Control

Ages Eligible for Study: 45 Years to 65 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Accepts Healthy Volunteers
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

Active Choice Regarding Cardiovascular Disease Risk

Location Details


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Active Choice Regarding Cardiovascular Disease Risk

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Locations


Not yet recruiting

Netherlands, Noord-Holland

VUMedicalCenter

Amsterdam, Noord-Holland, Netherlands, 1018BT

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