Active Choice Regarding Cardiovascular Disease Risk

Cardiovascular Diseases Clinical Trial

Official title:

Actively Choosing How to Cope With an Increased Risk of Cardiovascular Disease: A Randomised Web-Based Experiment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05142280
• Other study ID #: 2021.0676
• Status: Completed
• Phase: N/A
• Start date: January 19, 2022
• Est. completion date: February 8, 2022

Study information

• Verified date: May 2022
• Source: Amsterdam UMC, location VUmc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 743
• Est. completion date: February 8, 2022
• Est. primary completion date: February 8, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases

Intervention

Other:
• Decision-aid for cardiovascular disease risk
The active choice intervention aims to promote an active choice regarding coping with an increased risk of cardiovascular disease. This means that individuals should (a) become aware of a discrepancy between the current and desired situation; (b) understand what the CVD risk means, and what its causes and consequences are; (c) evaluate the pros and cons of the different options to cope with the risk; and (d) are clear about their values regarding the choice.
• Control
The control condition contains information that resembles usual care by a GP regarding CVD prevention

Locations

Country	Name	City	State
Netherlands	VUMedicalCenter	Amsterdam	Noord-Holland

Sponsors (1)

Lead Sponsor	Collaborator
Amsterdam UMC, location VUmc

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Perceived Health according to the Research and Development 36	Questionnaire item that measures participants' perceived health on a 5-point scale. This is the first item from the questionnaire 'Research and Development 36' (RAND-36). A higher score indicates better perceived health.	Directly after the intervention
Other	Control Preference Scale	The questionnaire item was adapted from the Control Preferences Scale. A lower score indicates that someone prefers to take decisions himself, whereas a higher score indicates that someone prefers to leave the decision to his doctor.	Directly after the intervention
Primary	Active choice	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.	Directly after the intervention
Primary	Intention strength	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.	Directly after the intervention
Primary	Commitment	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.	Directly after the intervention
Secondary	Intention	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.	Directly after the intervention
Secondary	Self-efficacy	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.	Directly after the intervention
Secondary	Response efficacy	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.	Directly after the intervention
Secondary	Autonomous motivation subscale of the Treatment Motivation Questionnaire	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.	Directly after the intervention
Secondary	Knowledge	4 self-constructed questionnaire items measuring knowledge about CVD. Response options: Agree; Disagree; Don't know.	Directly after the intervention
Secondary	Cognitive risk perception	Self-constructed questionnaire item measuring participants' cognitive risk perception. The item has a 5-point scale ranging from 'very small' to 'very big'.	Directly after the intervention
Secondary	Affective risk perception	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.	Directly after the intervention
Secondary	Lifestyle change intention	Self-constructed questionnaire item. Measures participants' intention regarding lifestyle change. 4 options: Quit smoking; Eat healthier; Become more physically active; Other.	Directly after the intervention