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临床试验/NCT05142280
NCT05142280已完成不适用

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

Amsterdam UMC, location VUmc1 个研究点 分布在 1 个国家目标入组 743 人开始时间: 2022年1月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
743
试验地点
1
主要终点
Active choice

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
45 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Adults aged 45-65 years

排除标准

  • •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

研究组 & 干预措施

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.

干预措施: Decision-aid for cardiovascular disease risk (Other)

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.

干预措施: Control (Other)

结局指标

主要结局

Active choice

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • Knowledge(Directly after the intervention)
  • Self-efficacy(Directly after the intervention)
  • Response efficacy(Directly after the intervention)
  • Affective risk perception(Directly after the intervention)
  • Lifestyle change intention(Directly after the intervention)
  • Autonomous motivation subscale of the Treatment Motivation Questionnaire(Directly after the intervention)
  • Cognitive risk perception(Directly after the intervention)
  • Intention(Directly after the intervention)

研究者

发起方
Amsterdam UMC, location VUmc
申办方类型
Other
责任方
Principal Investigator
主要研究者

Lorraine Landais

Principal Investigator

Amsterdam UMC, location VUmc

研究点 (1)

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