Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05142280
Status:
COMPLETED
Last Update Posted:
2022-05-13
First Post:
2021-11-19
Brief Title:
Active Choice Regarding Cardiovascular Disease Risk
Sponsor:
Amsterdam UMC location VUmc
Organization:
Amsterdam UMC location VUmc
Study Overview
Official Title:
Actively Choosing How to Cope With an Increased Risk of Cardiovascular Disease A Randomised Web-Based Experiment
Status:
COMPLETED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg degree of active choice commitment toward the chosen option compared to usual care ie a GPs advice to change ones 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 hisher 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 hisher values regarding the choice The different options to cope with an increased CVD risk include changing ones 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 ie quit smoking eat healthier become more physically active In addition GPs regularly advice their patients to take antihypertensive andor 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 eg degree of active choice commitment toward the chosen option compared to usual care ie a GPs advice to change ones 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 hisher 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 hisher values regarding the choice The different options to cope with an increased CVD risk include changing ones 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 ie active choice group and control group ie 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 GPs advice Ultimately a more active choice is expected to results in greater behavioural persistence regarding the chosen option ie lifestyle change andor medication adherence
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 eg degree of active choice commitment toward the chosen option compared to usual care ie a GPs advice to change ones 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 hisher 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 hisher values regarding the choice The different options to cope with an increased CVD risk include changing ones 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 ie active choice group and control group ie 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 GPs advice Ultimately a more active choice is expected to results in greater behavioural persistence regarding the chosen option ie lifestyle change andor medication adherence
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None