Primary prevention of cardiovascular diseases (addressing CVD risk factors) Not Applicable
Conditions
Interventions
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 p
Sponsors
University of Antwerp
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
Exclusion criteria: 1. Mentally ill 2. Non-consenting adults 3. At low or high risk for CVD based on Interheart profiling score
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/01/2020: The primary outcomes of this study are implementation outcomes. In order to achieve the aims of our process evaluation we use the RE-AIM framework for evaluating our mixed method implementation study and use it as a preliminary guide and adapt it to our study setting to formulate the key areas to evaluate. RE-AIM is the acronym for five evaluation components: reach, effectiveness, adoption, implementation, and maintenance. 1. Reach The reachability of the intervention package will be assessed in terms of the absolute number, the proportion, and representativeness of sites who are willing to participate in the SPICES intervention. The number, the proportion, and representativeness of the individuals (staff, patients, community,…) from each site who take part in the SPICES intervention. 2. Effectiveness/efficacy The positive or negative effects which the implementation of a SPICES program will be evaluated through mixed methods a. The population survey will be used to evaluate the effectiveness of the intervention in improving participant knowledge, perception and change in risk behavior. b. Behavior change outcomes (pre-post) c. Notes from records kept from engagement meetings with staff. d. Recorded contacts made from contacts with sites and all relevant stakeholders 3. Adoption The absolute number, the proportion, and representativeness of sites and the stakeholders who are willing to initiate the SPICES program3.1 Notes from records kept from engagement meetings with staff. a. Recorded contacts made from contacts with sites and all relevant stakeholders 4. Implementation SPICES program agents’ fidelity to the various elements of the SPICES protocol—includes consistency of delivery and time and cost of intervention. a. Records of costs of training, material, etc. of each component of the SPICES program b. Notes from records kept from engagement meetings with staff. c. Recorded contacts made from contacts with sites | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 27/01/2020: Pre-post (Intermediate Risk cohort) 1. InterHeart risk score (translated to Dutch). 2. CVD risk awareness: ABCD questionnaire (validated in English, translated to Dutch) 3. Quality of life: WHOQOL bref (validated in Dutch) 4. Smoking level (Reduction of smokers/ reduction of number of cigarettes per smoker) 5. Improvement of diet (fruits/ vegetables consumption): Dash-Q (translated to Dutch and adapted to Belgian context), Feel4Diabetes diet questionnaire (validated in Dutch). 6. Activity level using the shortened version of the International Physical Activity questionnaire: short IPAQ (validated in Dutch) 7. Alcohol consumption (weekly declarative dose of alcohol) 8. The change in CVD knowledge, risk perception, intention to change, and physical activity behavior will be assessed using a population survey at baseline and 12 months. Previous secondary outcome measures: Pre – post (Intermediate Risk cohort) 1. InterHeart risk score (translated to Dutch). 2. CVD risk awareness: ABCD questionnaire (validated in English, translated to Dutch) 3. Quality of life: WHOQOL bref (validated in Dutch) 4. Smoking level (Reduction of smokers/ reduction of number of cigarettes per smoker) 5. Improvement of diet (fruits/ vegetables consumption): Dash-Q (translated to Dutch and adapted to Belgian context), Feel4Diabetes diet questionnaire (validated in Dutch). 6. Activity level using the shortened version of the International Physical Activity questionnaire: short IPAQ (validated in Dutch) 7. Alcohol consumption (weekly declarative dose of alcohol) | — |
Countries
Belgium
Outcome results
None listed