Interventions for cardiovascular disease prevention in sites in Europe
| ISRCTN | ISRCTN14008286 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14008286 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | SPICES_Belgium |
| Sponsor | University of Antwerp |
| Funder | Horizon 2020 |
- Submission date
- 23/04/2019
- Registration date
- 10/05/2019
- Last edited
- 14/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Cardiovascular diseases are the main cause of morbidity and mortality with an increasing economic burden in healthcare. One in three deaths is attributed to a cardiovascular disease. 90% of morbidity and mortality in cardiovascular disease is associated with preventable lifestyle-related risk factors, including poor diet, smoking and lack of exercise Adults are less at risk of cardiovascular disease if they follow a healthy diet and increase their daily exercise. This confirms the importance of primary prevention measures. In practice, there is therefore a need for structured optimization of behavioral change to a healthy lifestyle. Moreover, the current evidence supports a link between inequalities in socio-economic status (SES) and CVD, CVD risk factors and unhealthy lifestyle, making people with a low SES more vulnerable to developing a CVD. To support the overburdened primary health care in systematically taking preventive tasks in the context of cardiovascular disease, care models such as interprofessional working in general practice with a nurse practitioner and engaging social workers in a community in working on health, can be solutions to meet current care needs in primary care. The context of Belgian primary health care is currently evolving from fragmented care to an integrated approach led by policymakers. This offers a solid input for the sustainability of this project. Current developments with regard to the integration of nursing competencies in general practice can be an important opportunity to optimize cardiovascular prevention in primary care.
In addition, we have learned from our stakeholder meetings that welfare organizations are open to enable CVD profiling with existing community initiatives, in addition to reaching the part of our target population that is not yet registered with a general practice (proportional universalism perspective). It will be interesting to investigate these opportunities as a possible solution for improving the accessibility of preventive care for cardiovascular diseases.
Purpose of the study:
The primary goal of this study is to investigate how a CVD primary prevention program, consisting of a profiling and multi-component behavioral change intervention, can be implemented in primary health care and welfare organizations in vulnerable (high proportion of people with low socio-economic status) Antwerp city districts in Belgium, to support people to be aware of their cardiovascular risk and change their risk behavior for the primary prevention of CVD.
The secondary objectives of this study are (1) monitoring the impact of the SPICES program on individual behavioral outcomes (self-reported health behavior) in persons with moderately increased CVD risk and (2) monitoring the impact of the presence of a SPICES program in the target regions for “awareness” of CVD risk and the importance of a healthy lifestyle at a broader population level.
Who can participate?
Adults aged between 40-65 years in Deurne, Borgerhout or Wommelgem (Antwerp, Belgium) who give consent to participate and are at moderately increased risk of developing CVD based on the Interheart profiling tool score.
What does the study involve?
All participants will receive the same evidence-based intervention as stated below. Follow-up measures include pre-post evaluation with self-reported health behavior outcomes (questionnaires every 6 months).
1. Profiling
The first step in behavioral change is to be aware of the individual risk for heart disease. With the help of the non-laboratory Interheart Risk Scoring tool, members of the population will be invited to participate through general practice or welfare organization. When participating, they are divided into 3 categories based on a number of questions: low, moderate, high risk of cardiovascular disease. Based on the score, the electronic interheart will automatically generate advice, which the profiler will transfer to the person using motivational interviewing techniques. The group with moderately increased risk is our target population within SPICES and will be referred to 2 behavioral change counseling interventions.
2. Behavioral change counseling
Here too, work is being carried out on 2 levels. General practices wishing to participate in this study will be supported in their preventive consultation. The community level will also look at which initiatives regarding healthy lifestyle are already present in the neighborhood and the providers / organizers will also be supported in their program here. In this way, this project wants to link primary care and community to each other and familiarize all stakeholders with the range of available initiatives.
What are the possible benefits and risks of participating?
All participants including patients will benefit from the planned interventions which include profiling for CVD risk factors and primordial prevention guidance and referral to health facilities. It is hoped that the intervention will increase the knowledge of members on CVD, understand their CVD risk profiles and support them to adopt healthy lifestyles to improve CVD prevention and control. Moreover, those identified with high risk profiles are referred to benefit from strengthened services at primary healthcare facilities. At the health facility, practices benefit from improved availability of supplies to support management of CVD risk factors and staff receive training which boosts their confidence and competence in the management of CVD risks.
Where is the study run from?
University of Antwerp - Faculty of Medicine and Health Sciences Department of Primary and Interdisciplinary care
When is the study starting and how long is it expected to run for?
December 2018 to August 2021
Who is funding the study?
Horizon 2020, European commission
Who is the main contact?
Miss Naomi Aerts (scientific contact), naomi.aerts@uantwerpen.be
Contact information
Scientific
University of Antwerp
Faculty of Medicine and Health Sciences
Department of Primary and Interdisciplinary care
Campus Drie Eiken - Gouverneur Kinsbergencentrum - Room 01.43
Doornstraat 331
Wilrijk (Antwerp)
2610
Belgium
 ORCID ID |
0000-0002-9338-1871 |
|---|---|
| Phone | +3232659113 |
| naomi.aerts@uantwerpen.be |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Hybrid type III convergent parallel mixed method design |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Scaling-up packages of interventions for cardiovascular disease prevention in selected sites in Europe and sub-Saharan Africa: an implementation research |
| Study acronym | SPICES |
| Study objectives | General objectives 1. To implement, and evaluate the impact, of a comprehensive CVD prevention program in a population in a Belgian urban setting with a high number of ‘vulnerable’ inhabitants with low socio-economic status. 2. To identify the contextual barriers and facilitators that influence the scale-up of the comprehensive CVD prevention interventions and compare them across SPICES study sites. |
| Ethics approval(s) | Approved 08/04/2019, Ethics committee of Antwerp University Hospital (Ethics committee UZA, UZA Wilrijkstraat 10, 2650 Edegem, Antwerp, Belgium; + 32 3 821 35 44; ethisch.comite@uza.be) ref: B300201940009. Study tracking number: 19/13/171. |
| Health condition(s) or problem(s) studied | Primary prevention of cardiovascular diseases (addressing CVD risk factors) |
| Intervention | 1. CVD profiling & risk communication The identification of people who might be at risk for CVD (profiling), will be obtained by using the InterHeart tool; this choice is supported by a scoping literature review and consensus with consortium partners. This first intervention will be carried out on two levels, being GP practices and in the community. GP practices: CVD risk profiling, amongst other preventive tasks, falls under the responsibility of general practitioners. However, in current practice we see that this does not happen in a systematic way, which makes this an opportunity for improvement through task shifting to the community? Community: Lay people who are active in welfare organizations (depending on organization, e.g. social workers, volunteers) and who are familiar with interacting with our target vulnerable population, have an entry-point given their pre-existing trust-based relationship. Moreover, people who don’t have a regular GP yet will be given the guidance towards primary health care when needed. Based on the InterHeart score, people will be stratified based on their CVD risk in three categories: green (low risk), amber (medium risk), red (high risk). Regardless of risk category or setting, all profiled individuals will receive very brief advice and if necessary a referral appropriate to their risk, preferences and needs. -Very brief advice: A very brief advice follows the communication of CVD risk, and together they are carried out in order to initiate patient activation and health seeking behavior for the amber and red scoring individuals. This knowledge transfer may be supported by educational materials (e.g. eHealth visualization of risk, leaflet). The green scoring individuals will receive a ‘supportive communication’: congratulation on successfully maintaining a healthy lifestyle, brief information on CVD risk factors, motivational message in sustaining healthy lifestyle in the future. -Referral: Profiles people get an individualized referral appropriate to their health needs derived from their risk score. 1. Green category: will be made aware of pre-existing, community based, bottom-up initiatives in the neighborhood (or within the organization that supports the profiling) that support the target lifestyle behavior(s). 2. Amber category: will be made aware of pre-existing, community based, bottom-up initiatives in the neighborhood (or within the organization that supports the profiling) that support the target lifestyle behavior(s). In addition, for this amber population we will focus on the group offer on lifestyle behavior that is already available and which is “SPICES-approved” (screen that offer for if it to the evidence and if the people who offer it are competent-if not the organizers get the support they need e.g. training). The amber people that are registered with a GP practice with a practice nurse that collaborates with SPICES, be referred to make an appointment with the practice nurse for follow-up of their CVD risk and behavior change. 3. Red category: will be referred to usual care 2. Brief behavior change counseling Behavioral counseling with the purpose of helping people change their unhealthy lifestyle, will be implemented in general practices, guided by the components as described in the 'Change4Health document'. During these counselling sessions, primary health care providers will be applying evidence-based behavioral change strategies, such as motivational interviewing, goal-setting, action-planning and problem-solving. These strategies imply a higher level of patient engagement, thanks to the focus on the patient’s perspective. Based on the recommendations found in international guidelines, follow-up of the behavior change will be pursued for at least one year. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
Current primary outcome measure as of 27/01/2020: |
| Key secondary outcome measure(s) |
Current secondary outcome measures as of 27/01/2020: |
| Completion date | 31/12/2021 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 382 |
| Key inclusion criteria | Current participant inclusion criteria as of 27/01/2020: To be included to the cohort; 1. Both male and female 2. Aged 40-65 years 3. Consent to participate in the study 4. At moderate risk for CVD based on Interheart profiling score For population survey: 1. Age ≥18 years 2. Consent to participate in the study Previous participant inclusion criteria: 1. Both male and female 2. Aged 40-65 years 3. Consent to participate in the study 4. At moderate risk for CVD based on Interheart profiling score |
| Key exclusion criteria | 1. Mentally ill 2. Non-consenting adults 3. At low or high risk for CVD based on Interheart profiling score |
| Date of first enrolment | 01/12/2018 |
| Date of final enrolment | 30/08/2021 |
Locations
Countries of recruitment
- Belgium
Study participating centre
Gouverneur Kinsbergencentrum
Doornstraat 331
Wilrijk (Antwerp)
2610
Belgium
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Stored in repository |
| IPD sharing plan | The datasets generated during and/or analysed during the current study will be stored in a repository. Access can be requested from the PI a year after completion of the study. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | Qualitative process evaluation study | 08/03/2023 | 14/06/2023 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
14/06/2023: Publication reference added.
27/01/2020: The following changes have been made:
1. The primary outcome measures have been updated.
2. The secondary outcome measures have been updated.
3. The participant inclusion criteria have been updated.
24/04/2019: Trial’s existence confirmed by Ethics committee of Antwerp University Hospital (Ethics committee UZA).
