Introduction: Hip and knee osteoarthritis are associated with functional limitations, pain and restrictions in quality of life and the ability to work. Furthermore, with growing prevalence, osteoarthritis is increasingly causing (in)direct costs. Guidelines recommend exercise therapy and education as primary treatment strategies. Available options for treatment based on physical activity promotion and lifestyle change are often insufficiently provided and used. In addition, the quality of current exercise programmes often does not meet the changing care needs of older people with comorbidities and exercise adherence is a challenge beyond personal physiotherapy. The main objective of this study is to investigate the short- and long-term (cost-)effectiveness of the SmArt-E programme in people with hip and/or knee osteoarthritis in terms of pain and physical functioning compared to usual care. Methods: This study is designed as a multicentre randomized controlled trial with a target sample size of 330 patients. The intervention is based on the e-Exercise intervention from the Netherlands, consists of a training and education programme and is conducted as a blended care intervention over 12 months. We use an app to support independent training and the development of self-management skills. The primary and secondary hypotheses are that participants in the SmArt-E intervention will have less pain (numerical rating scale) and better physical functioning (Hip Disability and Osteoarthritis Outcome Score, Knee Injury and Osteoarthritis Outcome Score) compared to participants in the usual care group after 12 and 3 months. Other secondary outcomes are based on domains of the Osteoarthritis Research Society International (OARSI). The study will be accompanied by a process evaluation. Discussion: After a positive evaluation, SmArt-E can be offered in usual care, flexibly addressing different care situations. The desired sustainability and the support of the participants' behavioural change are initiated via the app through audio-visual contact with their physiotherapists. Furthermore, the app supports the repetition and consolidation of learned training and educational content. For people with osteoarthritis, the new form of care with proven effectiveness can lead to a reduction in underuse and misuse of care as well as contribute to a reduction in (in)direct costs.
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Background: The environment affects children’s energy balance-related behaviors to a considerable extent. A context-based physical activity and nutrition school- and family-based intervention, named KEIGAAF, is being implemented in low socio-economic neighborhoods in Eindhoven, The Netherlands. The aim of this study was to investigate: 1) the effectiveness of the KEIGAAF intervention on BMI z-score, waist circumference, physical activity, sedentary behavior, nutrition behavior, and physical fitness of primary school children, and 2) the process related to the implementation of the intervention. Methods: A quasi-experimental, controlled study with eight intervention schools and three control schools was conducted. The KEIGAAF intervention consists of a combined top-down and bottom-up school intervention: a steering committee developed the general KEIGAAF principles (top-down), and in accordance with these principles, KEIGAAF working groups subsequently develop and implement the intervention in their local context (bottom-up). Parents are also invited to participate in a family-based parenting program, i.e., Triple P Lifestyle. Children aged 7 to 10 years old (grades 4 to 6 in the Netherlands) are included in the study. Effect evaluation data is collected at baseline, after one year, and after two years by using a child questionnaire, accelerometers, anthropometry, a physical fitness test, and a parent questionnaire. A mixed methods approach is applied for the process evaluation: quantitative (checklists, questionnaires) and qualitative methods (observations, interviews) are used. To analyze intervention effectiveness, multilevel regression analyses will be conducted. Content analyses will be conducted on the qualitative process data. Discussion: Two important environmental settings, the school environment and the family environment, are simultaneously targeted in the KEIGAAF intervention. The combined top-down and bottom-up approach is expected to make the intervention an effective and sustainable version of the Health Promoting Schools framework. An elaborate process evaluation will be conducted alongside an effect evaluation in which multiple data collection sources (both qualitative and quantitative) are used.
