2.3.1. Effectiveness Study
REGRESSION, HEART, RECRUITMENT
Participants recruited during two observation periods were compared: the control period (all patients receiving standard care) versus the intervention period (all patients receiving standard care and who were offered to participate in the Healthy Heart programme). A third group of patients, who did not complete questionnaires, served as an extra control group for the outcome measurements derived from the EHR, as this group was not biased by motivation for completing or the content of the questionnaires. The baseline measurement for this group was set as their first GP visit after 1 July 2017 (start of the recruitment period).Differences between the intervention and control period in goalsetting and self-perceived achieved goals were assessed with chi-square tests and differences in motivation and confidence in lifestyle changes were assessed with independent To examine the outcomes, multivariate linear, ordinal (alcohol) and Poisson (number of visits to primary practice) mixed models were used. Mixed models for (1) the period 3–6 months and (2) 12–24 months after baseline were calculated with period (control/intervention) as fixed effect and with random effects for participant and practice, adjusted for baseline measurement of the outcome, sex, age, antihypertensive- (SBP model) and lipid-lowering medication usage (LDL- and HDL-cholesterol model) and total general self-efficacy scale (alcohol model). For weight, SBP and cholesterol measurements, a period of 1.5 months–7.5 months and 10–26 months was included in the analysis to include all in-between measurements in the models. For CVRM-related practice-consultations, the timeframes 0–12 and 12–24 months were analysed. To assess effect modification with sex and age, an interaction term with group and these determinants were added to the models. Due to a limited number of current smokers, difference between the control and intervention period on smoking cessation (yes) was examined using logistic regression analysis with 7-day abstinence at 3 or 6 months and 6-month abstinence at 12 or 24 months.We performed two in-depth analyses. First, in order to examine the effect of the Healthy Heart programme itself, we repeated the models with participants who participated in the programme compared to those who did not (recruited both during the control and intervention period). Additionally, to assess external validity, we repeated the models regarding weight, SBP and cholesterol-levels of participants recruited during the intervention period compared to participants in the EHR-group for 12–24 months. Since routine consultations occur annually, measurements at 3–6 months in the EHR are likely to mainly include suboptimal outcomes.