46 | Chapter 3 Data collection and outcome measures Primary outcome measure The primary outcome in this study is the number of falls, with or without injuries, assessed with fall diaries and monthly follow-up telephone calls, including questions on the causes, circumstances and consequences of falls. This combination of pro- and retrospective data collection follows guidelines for conducting fall prevention trials (156). Secondary outcome measures Besides the number of falls and fall-related injuries, positive effects on physical functioning, physical activity, quality of life and other self-reported outcome measures are measured (157). The secondary outcome measures will be assessed at three time points during the study period; at entry of the study (baseline, M0), after 4 months to determine the short-term effects (M4) and after 12 months to determine the long-term effects (M12). Societal costs will be assessed at M4, after 8 months (M8) and M12. All secondary outcomes are listed in Table 3.2 and are described in detail below. Questionnaires The participants will receive and fill in questionnaires at their homes. Participants can choose whether they want to receive the questionnaires online (by email) or on paper. Participant characteristics Demographic characteristics will be determined at M0 and M12, including age, sex, height, weight, marital status, living situation, work, smoking, fall history, use of walking aids, experience with fall prevention interventions, walking, balance, physical activity, use of medication and presence of chronic diseases. Well-being and fall-related concern At M0, M4 and M12, several questionnaires will be used. General health status will be determined with the 36-Item Short Form Health Survey (149) and the Positive Health Inventory Tool (158). Empowerment will be determined with the Pearlin Mastery Scale (159) and the General Self-Efficacy Scale (160). Concern about falling will be determined with the Falls Efficacy Scale International (161). Fall risk will be measured with the Longitudinal Aging Study Amsterdam Fall Risk Questionnaire (162). Walking confidence will be determined with the Modified Gait Efficacy Scale (163). General quality of life will be assessed using the five-level version of the EuroQol questionnaire (EQ-5D-5L) (164). Last, to measure quality of life from a broader perspective than health alone, the Adult Social Care Outcomes Toolkit will be used (165).
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