52 | Chapter 3 implementation, re-evaluation of the (cost-)effectiveness of the current In Balance intervention is urgently needed. One strength of this study is that we re-evaluate the widely implemented In Balance fall prevention intervention. In this evaluation, we will stratify for frailty status, which allows us to investigate the impact of the In Balance intervention for different target groups on which the intervention has been extended since implementation. Another strength is that, besides investigating the effectiveness on falls and fall-related injuries, we also study the cost-effectiveness of the In Balance intervention. Little research has been conducted examining the cost-effectiveness of fall prevention interventions in general and no research has been done before on the cost-effectiveness of the In Balance intervention specifically (143). The cost-effectiveness analysis will indicate whether the added health benefits of the In Balance intervention outweigh the costs. An additional strength of this study is that we do not only take falls and fall-related injuries into account, which have a large impact on the individual and healthcare, but we will also investigate multiple secondary outcomes such as physical functioning, physical activity, quality of life and other self-reported outcome measures (136). Despite the health benefits of physical activity, the paradoxical increase in exposure to fall risk should also be taken into account when evaluating falls prevention interventions (181). Although this study is not powered for the secondary outcome measures, analysis of these outcomes will nevertheless provide insights that are useful to gain more knowledge about the underlying mechanisms of the In Balance intervention on a potential reduction of falls and fall-related injuries. For example, physical activity improves balance control and muscle and bone strength and thus is expected to decrease the number of falls and fall-related injuries (28, 72-74). This study also includes a process evaluation, to collect information that will be relevant for further implementation of the intervention. Not part of this protocol, but additionally to the process evaluation, we consider focus groups with participants of the intervention group, therapists and other stakeholders to obtain facilitating and hindering factors for implementation. These factors can be taken into account when implementing the outcomes of the study described in this research protocol. Several challenges of this study need to be mentioned as well. First, the inclusion of 256 participants in this trial, both non-frail and pre-frail, will be challenging. For recruitment, we will involve therapists and their local network over diverse neighbourhoods. Due to the COVID-19 situation, the inclusion of sufficient participants will be extra challenging. We expect that participants may be reticent when considering participating in the In Balance intervention, although the majority of our target population is expected to be vaccinated at the start of
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