A nationwide cardiovascular disease in women awareness campaign: a digital randomised controlled trial
| ISRCTN | ISRCTN83226586 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83226586 |
- Submission date
- 03/10/2022
- Registration date
- 21/10/2022
- Last edited
- 21/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
It is well known that cardiovascular disease is the number one killer in men. In the last two decades it has become clear that cardiovascular disease is the number one killer for women as well. In the Netherlands, women have even overtaken men in the incidence of cardiovascular disease, especially stroke. However, a large survey study in the USA showed that only 56% of women are aware that cardiovascular disease is a number one killer for them. In addition, it seems that women are unaware of their cardiovascular risk factors (including women's specific risk factors like pregnancy-related hypertension). It also seems that both men and women are unrealistic optimistic about their own cardiovascular risk.
This evidence-based cardiovascular disease in women awareness campaign study will be conducted to improve awareness of cardiovascular disease in women and underlying risk factors in the Dutch population, especially among women, by comparing a specific health messaging strategy with a generic health messaging strategy.
In the observational phase, gaps in the population's awareness of cardiovascular disease in women and underlying risk factors are measured through a diagnostic survey, among the general Dutch population, and specifically in relation to sex differences and different personality traits.
In the interventional phase, different video interventions (with specific or generic health messages) will be shown to participants and subsequent questionnaires will be filled out with the aim to define the most effective health messaging strategy, specifically designed, to establish better awareness of cardiovascular disease in women and underlying risk factors, compared to a generic health messaging strategy. Another aim is to establish a better, specific compared to generic health messaging strategy, reduction of self-reported risk factors and improvement of cardiovascular health.
Who can participate?
People aged 18 years or older
What does the study involve?
The study consists of questionnaires and an educational intervention video. Participants will fill out a questionnaire at the start of the study and one or more questionnaires after watching the intervention video. Each participant will be randomly assigned to one of the intervention videos. There will be a control (generic) video and one or more video(s) which are specifically tailored based on the gaps in awareness. The intervention video with the best performance on improvement of awareness will contribute to the improvement and the design of subsequent campaigns.
What are the possible benefits and risks of participating?
The collective benefit of participation includes helping to design an evidence-based health care campaign with the aim to reduce the burden of cardiovascular disease in women in the Netherlands. The individual benefit of participating in this study is improved awareness and prevention of cardiovascular disease, and underlying risk factors.
There are no anticipated risks of participating.
Where is the study run from?
Amsterdam UMC (Netherlands)
When is the study starting and how long is it expected to run for?
March 2020 to June 2023
Who is funding the study?
Dutch Cardiovascular Alliance (DCVA)
Who is the main contact?
Prof. Dr Leonard Hofstra
l.hofstra@cardiologiecentra.nl
Contact information
Scientific
De Boelelaan 1117 / 1118
Amsterdam
1081HV
Netherlands
 ORCID ID |
0000-0003-4432-4720 |
|---|---|
| Phone | +31 (0)20 4442244 |
| l.hofstra@cardiologiecentra.nl |
Public
De Boelelaan 1117 / 1118
Amsterdam
1081HV
Netherlands
| ORCID ID |
0000-0001-6905-3870 |
|---|---|
| Phone | +31 (0)20 4442244 |
| g.l.habib@amsterdamumc.nl |
Principal Investigator
De Boelelaan 1117 / 1118
Amsterdam
1081HV
Netherlands
| Phone | +31 (0)20 4442244 |
|---|---|
| l.hofstra@cardiologiecentra.nl |
Study information
| Study design | Observational (cross-sectional study) and interventional (randomised controlled trial) |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | A nationwide cardiovascular disease in women awareness campaign, using specific compared to generic health messaging to improve awareness of cardiovascular disease in women and underlying risk factors among the Dutch population: a digital randomised controlled trial |
| Study objectives | 1. Rationale: Understanding the gaps in awareness of cardiovascular disease in women and underlying risk factors in the Dutch population, and in relation to difference in sex and personality traits 2. Hypothesis: A cardiovascular disease in women awareness campaign, using specific compared to generic health messages, results in a substantial improvement of awareness of women's cardiovascular disease and underlying risk factors in the Dutch population. |
| Ethics approval(s) | Approved 30/03/2020, Amsterdam UMC Medical Ethics Review Committee (METC) (De Boelelaan 1117, 1118, 1081HV, Netherlands; +31 (0)204443394; metc@vumc.nl), ref: 2020.178 |
| Health condition(s) or problem(s) studied | Improving awareness (of underlying risk factors) and prevention of cardiovascular disease in women among the Dutch population. |
| Intervention | This study will consist of an observational and an interventional phase. In the observational phase, a diagnostic survey will be conducted, where gaps in awareness of cardiovascular disease in women and underlying risk factors are measured. In the interventional phase different educational intervention videos (with specific vs. general health messages), based on the outcomes of the diagnostic survey, will be produced and shown to the study participants. Participants are randomised to watch one of our different intervention videos and will subsequently fill out multiple questionnaires. Randomisation will take place via qualtrics.com (questionnaire website). The intervention videos will be evenly randomised to the participants. Therefore, the number of participants will be evenly distributed across all intervention videos. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Understanding the gaps in awareness of cardiovascular disease in women and underlying risk factors (lifestyle factors, women specific risk factors, optimism bias, time-inconsistency), and in relation to difference in sex and different personality traits. This is measured using a questionnaire (diagnostic survey) at baseline. 2. Definition of the most effective health messaging strategy, specific compared to generic health messages, to improve awareness of cardiovascular disease in women and underlying risk factors, measured using questionnaires before (at baseline) and after showing the different intervention videos. |
| Secondary outcome measures | 1. Improvement of self-reported risk factors for cardiovascular disease (improvement of cardiovascular health), measured using questionnaires before (at baseline) and after showing the intervention video |
| Overall study start date | 29/03/2020 |
| Completion date | 01/06/2023 |
Eligibility
| Participant type(s) | All |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 2500 |
| Key inclusion criteria | 1. Provide informed consent 2. Aged 18 years or older |
| Key exclusion criteria | Does not meet the inclusion criteria |
| Date of first enrolment | 31/10/2022 |
| Date of final enrolment | 01/06/2023 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Amsterdam
1081HV
Netherlands
Sponsor information
Research organisation
Moreelsepark 1
Utrecht
3511EP
Netherlands
| Phone | +31 302333600 |
|---|---|
| info@dcvalliance.nl | |
| Website | https://www.dcvalliance.nl |
Funders
Funder type
Research organisation
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- DCVA
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/06/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be available upon request from G.L. Habib, g.l.habib@amsterdamumc.nl. Further data-sharing plans for the current study will be made available at a later date. |
Editorial Notes
13/10/2022: Trial's existence confirmed by Dutch Cardiovascular Alliance.
