Active Choice Regarding Cardiovascular Disease Risk

NCT05142280 | Completed

• 1 other identifier: 2021.0676
• Study Type: interventional
• Target: 743
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Cardiovascular Diseases

Keywords

Prevention; Active choice; Decision-making

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Intention

  Directly after the intervention

• Self-efficacy

  Directly after the intervention

• Response efficacy

  Directly after the intervention

• Autonomous motivation subscale of the Treatment Motivation Questionnaire

  Directly after the intervention

• Knowledge

  Directly after the intervention

Other Outcomes (2)

• Perceived Health according to the Research and Development 36

  Directly after the intervention

• Control Preference Scale

  Directly after the intervention

Study Arms (2)

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.

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.

Other: Control

Interventions

Decision-aid for cardiovascular disease risk OTHER

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.

Also known as: Active choice intervention for cardiovascular disease risk

Active choice

Control OTHER

The control condition contains information that resembles usual care by a GP regarding CVD prevention

Also known as: Usual Care

Control

Eligibility Criteria

• Age: 45 Years - 65 Years
• Gender Eligibility Details: The investigators will investigate effect modification by gender. Therefore, the investigators aim to recruit 412 men and 312 women.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 45-65 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Amsterdam UMC, location VUmc: lead

Study Sites (1)

VUMedicalCenter

Amsterdam, North Holland, 1018BT, Netherlands

Location

Related Publications (1)

• 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.

  PMID: 39088470 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases

Interventions

Decision Support Techniques

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Danielle Timmermans, Prof

  VU Medical Center, Amsterdam UMC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Web-based randomized controlled trial

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: December 2, 2021
• Study Start: January 19, 2022
• Primary Completion: February 8, 2022
• Study Completion: February 8, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study protocol will be permanently available. Participant data will be deleted 15 years after study completion.
• Access Criteria: No access restrictions for the study protocol.

Locations

NL (1)