Active Choice Regarding Cardiovascular Disease Risk

Not Applicable

Completed

• Conditions: Cardiovascular Diseases

• Registration Number: NCT05142280
• Lead Sponsor: Amsterdam UMC, location VUmc

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.

Study Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2021-11-19
• Study First Posted: 2021-12-02
• Study Start: 2022-01-19
• Primary Completion: 2022-02-08
• Study Completion: 2022-02-08
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-09
• Last Update Posted: 2022-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 743

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Active choice	Directly after the intervention	Self-constructed scale. Measures the degree to which participants make an active choice. The scale contains 11 items that have to be answered on a scale of 1 (totally disagree) to 5 (totally agree). A higher mean score on the scale indicates a better outcome.
Commitment	Directly after the intervention	5 self-constructed questionnaire items on a scale of 1 (not at all) to 10 (very much). Measure commitment to perform the chosen behaviour (i.e., lifestyle change and/or taking medication). A higher mean score indicates a better outcome.
Intention strength	Directly after the intervention	2 self-constructed questionnaire items on a scale of 1 (not strong at all) to 10 (very strong). Measure intention strength to perform the chosen behaviour (i.e., lifestyle change and/or taking medication). A higher score indicates a better outcome.

Secondary Outcome Measures

Name	Time	Method
Self-efficacy	Directly after the intervention	2 self-constructed questionnaire items on a scale of 1 (not strong at all) to 10 (very strong). Measure self-efficacy regarding performing the chosen option (i.e., lifestyle change and/or taking medication). A higher score indicates a better outcome.
Response efficacy	Directly after the intervention	2 self-constructed questionnaire items on a scale of 1 (not at all) to 10 (totally). Measure response efficacy regarding coping with an increased CVD risk. A higher mean score indicates a better outcome.
Affective risk perception	Directly after the intervention	3 self-constructed questionnaire items measuring participants' affective risk perception on a scale of 1 (not at all) to 10 (very much). A higher score indicates more negative emotion associated with the hypothetical risk.
Lifestyle change intention	Directly after the intervention	Self-constructed questionnaire item. Measures participants' intention regarding lifestyle change. 4 options: Quit smoking; Eat healthier; Become more physically active; Other.
Autonomous motivation subscale of the Treatment Motivation Questionnaire	Directly after the intervention	6 questionnaire items adapted from the Treatment Motivation Questionnaire (TSRQ). The items measure the degree of autonomous motivation on a scale of 1 (totally disagree) to 7 (totally agree). A higher mean score on this subscale indicates a better outcome.
Knowledge	Directly after the intervention	4 self-constructed questionnaire items measuring knowledge about CVD. Response options: Agree; Disagree; Don't know.
Cognitive risk perception	Directly after the intervention	Self-constructed questionnaire item measuring participants' cognitive risk perception. The item has a 5-point scale ranging from 'very small' to 'very big'.
Intention	Directly after the intervention	Self-constructed questionnaire item. Measures intention regarding coping with CVD and intention regarding lifestyle change. 4 options: (a) Lifestyle change; (b) Taking medication; (c) Lifestyle change and taking medication; (d) change nothing.

Trial Locations

Locations (1)

VUMedicalCenter; 🇳🇱 Amsterdam, Noord-Holland, Netherlands