Lifestyle-related risk factors for cardiovascular disease I10 E11 E66 I25 I70
Conditions
Interventions
Group 1: Control group (KG): Application of the CVR calculator "arriba" (CVR = cardiovascular risk), No specifications of further measures
Group 2: Intervention group 1 (IG1): use of the CVR calculato
Sponsors
Universitätsklinikum Freiburg - Institut für Allgemeinmedizin
Eligibility
Sex/Gender
All
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) Member of a statutory health insurance (SHI). 2) At least one of the following lifestyle-related cardiovascular risk factors: smoking, obesity, lack of exercise, unhealthy diet, high alcohol consumption, unhealthy stress behaviour, lack of sleep. 3) Participation is possible in case of primary arterial hypertension and/or hypercholesterolaemia and/or diabetes mellitus type 1 or 2, manifest arteriosclerosis. 4) Sufficient understanding of the German language (reading, speaking)
Exclusion criteria
Exclusion criteria: 1) Patients after an acute cardiovascular event, 2) Patients with care level 1 or higher, 3) Patients with serious or severe acute illnesses or short life expectancy, 4) Patients who are planning a rehabilitation measure, 5) Patients with severe cognitive impairments, 6) Patients with severe mental illness, 7) Patients with alcoholism, severe eating disorders, 8) Pregnancy 9) Participation in the DECADE pilot study (2016) 10) Participation in the DECADE pre-study (focus group interviews; spring 2021) 11) Simultaneous participation in another study with the same or similar target criteria/measures.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Examination of the effects of the two components of the intervention (DECADE materials and structured follow-up counselling) on patient activation (PAM13) six months (t1) after the start of the study (baseline survey t0). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Examination of the effects of the two components of the intervention (DECADE materials and structured follow-up counselling) on the following secondary outcome measures at time t1 (6 months after baseline survey t0): a) improvement in current health status (validated instrument: EQ-5D VAS). b) Reduction of lifestyle-related risk factors. 2. Examination of the effects of the two components of the intervention on the primary and secondary outcome measures at time t2 (12 months after baseline survey t0). 3. Examination of the interaction effect of the two parts of the intervention on patient activation (PAM13) and on the secondary outcome measures. 4. Comparison of the statements on the "change in general health behaviour since the start of the study" in the groups with different components of the intervention at time points t1 and t2. 5. Comparison of the "achievement of own health goals" (adapted, validated instrument GAS) and "satisfaction with the achievement of health goals" (own development, pilot study) in the groups with different components of the intervention at time points t1 and t2. 6. Comparison of satisfaction with the DECADE materials (adapted from USE) in the groups with different components of the intervention at time points t1 and t2. 7. Comparison of the change in knowledge about cardiovascular diseases and possibilities of risk reduction (self-development) in the groups with different components of the intervention at time points t1 and t2. 8. Comparison of the extent of participation in cardiovascular risk counselling (following validated instrument PEF-FB-9) in the groups with different components of the intervention at time points t1 and t2. 9. Satisfaction with the GP cardiovascular risk consultations (own development; pilot study) in the groups with different components of the intervention at time points t1 and t2. 10. Statistical evidence of the cost-benefit ratio of the intervention components or of the complete DECADE intervent | — |
Countries
Germany
Outcome results
None listed