Xuxi Zhang

The fourth step of public health framework is to implement effective interventions and to evaluate their effect. The Social Engagement Framework for Addressing the Chronic ‐ disease ‐ challenge (SEFAC) project intends to empower citizens at risk of or with T2DM and/or cardiovascular disease (CVD) to self ‐ manage their chronic conditions through the SEFAC intervention. Following the fourth step of the public health approaches, we described the design of a prospective cohort study, which aims to evaluate the effects of the SEFAC intervention in Chapter 8 (see Figure 9.1.2). The SEFAC intervention combines the concepts of mindfulness, social engagement and information and communication technology support (ICT), in order to reduce the burden of citizens with chronic conditions and to increase the sustainability of the health system in four European countries. The project aims to study the effects of the SEFAC intervention on self ‐ management, healthy lifestyle behaviors, social support, stress, depression, sleep and fatigue, adherence to medications and HRQoL. There is also attention for the (cost ‐ ) effectiveness of the SEFAC intervention. The study aims to provide insight regarding the feasibility and effects of the intervention in different European countries and different settings. 9.2 METHODOLOGICAL CONSIDERATIONS The results of this thesis should be viewed in the light of some methodological considerations. Specific methodological considerations have been discussed for the studies in this thesis. In the following paragraphs some general methodological considerations will be described, related to the study design, study population, measurements and statistical analysis. Study design Chapters 2 ‐ 5 in this thesis used data from UHCE project, which is a controlled trial implemented in community settings at study sites in five European countries. Participants in the intervention group received care in accordance with the UHCE approach. In Chapter 2 , a cross ‐ sectional study with the baseline data of the UHCE project was conducted to study the association between frailty and HRQoL. However, the cross ‐ sectional design of this study did not allow for the assessment of a potential causal relationship between frailty and HRQoL. In Chapter 3 , a longitudinal design was used to study the association between physical activity and frailty. Participants in both the intervention and control group were included in the analyses. The UHCE approach may have led to improvement in health which could result in the over ‐ estimation of the effect of physical activity on frailty. Therefore, being in the intervention condition (or not) was a factor for which we adjusted the analyses regarding the association between physical activity and frailty; this was done by adding it to the regression models as a covariate. We also repeated the analyses for the control group only and found similar results. Additionally, we considered the results of those persons who had received specific UHCE approach may have had an effect on the changes in the frequency of physical activity. Therefore, we conducted a sensitivity analysis to control for specific UHCE interventions that may promote physical activity and found similar results. This study (Chapter 3) was an observational study, and therefore causality between physical activity and 226 Chapter 9