Cardiovascular DiseasesNCT05142280
Active Choice Regarding Cardiovascular Disease Risk
A study testing Decision-aid for cardiovascular disease risk in people with Cardiovascular Diseases, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
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… Read more about this study
- Who is it for?
- Ages 45 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Decision-aid for cardiovascular disease risk
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 743 participants
- Where
- 1 siteNetherlands
- Study dates
- 19 Jan 2022to 8 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 45-65 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- Decision-aid for cardiovascular disease risk, Control
- Keywords
- Prevention, Active choice, Decision-making
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decision-aid for cardiovascular disease riskOther
Also called Active choice intervention 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.
ControlOther
Also called Usual Care
The control condition contains information that resembles usual care by a GP regarding CVD prevention
| Study group | Role | What they receive |
|---|---|---|
| Active choice | Experimental | 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. Receives: Other: Decision-aid for cardiovascular disease risk |
| Control | Other | 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Directly after the intervention
Secondary outcomes (8)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Directly after the intervention
Knowledge
4 self-constructed questionnaire items measuring knowledge about CVD. Response options: Agree; Disagree; Don't know.
Measured: 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'.
Measured: 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.
Measured: 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.
Measured: Directly after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2021
- Study start19 Jan 2022
- Primary completion8 Feb 2022
- Study completion8 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Web-based randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 743 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amsterdam UMC, location VUmc
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lorraine Landais, Amsterdam UMC, location VUmc
- Investigators
- Danielle Timmermans, Prof, Study director, VU Medical Center, Amsterdam UMC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05142280
- Sponsor's protocol ID
- 2021.0676
- Status last verified
- May 2022
- First submitted
- 19 Nov 2021
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study protocol will be made available online on clinicaltrials.gov. Patient data will only be shared upon reasonable request.
Publications
Landais LL, Jelsma JGM, Damman OC, Verhagen EALM, Timmermans DRM. Fostering active choice to empower behavioral change to reduce cardiovascular risk: A web-based randomized controlled trial. PLoS One. 2024 Aug 1;19(8):e0304897. doi: 10.1371/journal.pone.0304897. eCollection 2024.
PubMed 39088470
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actively Choosing How to Cope With an Increased Risk of Cardiovascular Disease: A Randomised Web-Based Experiment
- ClinicalTrials.gov ID
- NCT05142280
- Acronym / sponsor ID
- 2021.0676
- Conditions
- Cardiovascular Diseases
- Keywords
- Prevention, Active choice, Decision-making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 743 participants (actual)
- Lead sponsor
- Amsterdam UMC, location VUmcUniversity, hospital or other
- Study start
- 19 Jan 2022 (actual)
- Primary completion
- 8 Feb 2022 (actual)
- Study completion
- 8 Feb 2022 (actual)
- First posted
- 2 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Web-based randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Active choice | Experimental | Other: Decision-aid for cardiovascular disease riskThis 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. |
| Control | Other | Other: ControlThe 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. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adults aged 45-65 years
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decision-aid for cardiovascular disease riskAlso: Active choice intervention for cardiovascular disease riskThe 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 | Active choice |
| ControlAlso: Usual CareThe control condition contains information that resembles usual care by a GP regarding CVD prevention | Other | Control |
Primary outcome
Active choice
Time frame: 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.
Intention strength
Time frame: 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.
Commitment
Time frame: 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.
8 secondary outcomes
Intention
Time frame: Directly after the intervention
Self-efficacy
Time frame: Directly after the intervention
Response efficacy
Time frame: Directly after the intervention
Autonomous motivation subscale of the Treatment Motivation Questionnaire
Time frame: Directly after the intervention
Knowledge
Time frame: Directly after the intervention
Cognitive risk perception
Time frame: Directly after the intervention
Affective risk perception
Time frame: Directly after the intervention
Lifestyle change intention
Time frame: Directly after the intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Derived from this study: PubMed 39088470Landais LL, Jelsma JGM, Damman OC, Verhagen EALM, Timmermans DRM. Fostering active choice to empower behavioral change to reduce cardiovascular risk: A web-based randomized controlled trial. PLoS One. 2024 Aug 1;19(8):e0304897. doi: 10.1371/journal.pone.0304897. eCollection 2024.
- Individual participant dataSharing planned: Yes. The study protocol will be made available online on clinicaltrials.gov. Patient data will only be shared upon reasonable request.
Related trials for Cardiovascular Diseases
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle Timmermans, Prof study director
VU Medical Center, Amsterdam UMC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decision-aid for cardiovascular disease risk in people with Cardiovascular Diseases, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Active choice (time frame: Directly after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05142280, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2022.