Active Choice Regarding Cardiovascular Disease Risk

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

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases
• Intervention / Treatment: Other: Decision-aid for cardiovascular disease risk; Other: Control

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
• Enrollment (Actual): 743
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Noord-Holland
    • Amsterdam, Noord-Holland, Netherlands, 1018BT
      • VUMedicalCenter

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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; 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.; Other Names: Active choice intervention 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; The control condition contains information that resembles usual care by a GP regarding CVD prevention; Other Names: Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Knowledge	4 self-constructed questionnaire items measuring knowledge about CVD. Response options: Agree; Disagree; Don't know.	Directly after the intervention
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Amsterdam UMC, location VUmc
• Investigators: Study Director: Danielle Timmermans, Prof, VU Medical Center, Amsterdam UMC

Study record dates

Study Major Dates

• Study Start (Actual): January 19, 2022
• Primary Completion (Actual): February 8, 2022
• Study Completion (Actual): February 8, 2022

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: November 19, 2021
• First Posted (Actual): December 2, 2021

Study Record Updates

• Last Update Posted (Actual): May 13, 2022
• Last Update Submitted That Met QC Criteria: May 9, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Prevention; Decision-making; Active choice
• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: 2021.0676

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The study protocol will be made available online on clinicaltrials.gov. Patient data will only be shared upon reasonable request.
• IPD Sharing Time Frame: The study protocol will be permanently available. Participant data will be deleted 15 years after study completion.
• IPD Sharing Access Criteria: No access restrictions for the study protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No