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The Belgian healthcare system is to a large extent hospital-centred, prompting government initiatives to shift care towards patient’s homes and reduce hospital stays. To avoid unnecessary hospital stays and offer alternative and innovative forms of care, the Belgian federal health authorities selected five pilot projects for transmural care for chronically ill children. Guided by the Medical Research Council framework, this study aims to evaluate the paediatric transmural care projects to inform new models for paediatric care.
Using a mixed-methods realist evaluation, the study comprises three phases: (1) initial programme theory development, (2) initial programme theory testing and (3) programme theory refinement. In a first phase, the initial programme theory rooted in the normalisation process theory will be refined from insights retrieved from document review and focus group interviews with healthcare professionals. In the second phase, the initial programme theory will be tested using empirical data. Routine data and questionnaires will examine whether characteristics of participants and outcomes are in line with the quintuple aim framework. Focus groups with children, parents and stakeholders, and document analysis will be used to evaluate the structure of the intervention, examine the process and context, and understand more in-depth the outcomes. A budget impact analysis will be used to assess whether the pilot project is affordable. In a third phase, qualitative and quantitative data will be analysed using a convergent mixed-methods model, involving continuous triangulation of multiple data sets to facilitate greater understanding of the context and refinement of the programme theory.
The study protocol was reviewed and approved by the Ethics Committee of the Ghent University Hospital (Belgian Registration Number B6702024000193) after consultation with all Ethics Committees of the participating hospitals. Written informed consent will be obtained from participants or their legal representatives prior to data collection. Participant confidentiality will be maintained throughout the study. Study results will be published in international peer-reviewed journals and will be presented at national and international conferences. The general population will be informed of the aggregated results.
ClinicalTrials.gov, NCT06679595.
Between 2020 and 2050, the world’s population aged 80 years and over will triple, drastically increasing the prevalence of frailty and associated healthcare costs. Multimodal exercise programmes have proven to be an ideal countermeasure for frailty, but the current Flemish standard of care does not include them. The purpose of this study is to investigate the effect of the home-based exercise programme for frail community-dwelling older adults (>70 years), ACTIVE-AGE@home, on frailty-associated outcomes, when delivered by professionals or volunteers, as well as its cost-effectiveness. A pragmatic randomised controlled trial will be conducted. Participants will be randomised into three parallel groups using permuted block randomisation. There will be two intervention groups: in one group, the intervention is delivered by professionals with a bachelor or masters’ degree in physiotherapy, occupational therapy and/or physical education, and in the other by trained volunteers. Both groups will be compared with a control group receiving usual care. Participants (n=195) are community-dwelling physically frail older adults (>70 years), as defined by Fried et al. (2001). The intervention is a 24 week programme that consists of three 1 hour visits per week and contains aerobic, strength, balance, flexibility, coordination and dual tasking exercises, accompanied by goal-setting and motivational interviewing. The Timed Chair Stand (TCS) test is the primary outcome. Functional ability, cognition, loneliness, self-management, health-related quality of life, healthcare utilisation and meaningful activities will be measured in all groups at 0, 24 and 48 weeks. Time and expenses invested by professionals or volunteers will be kept in diaries for trial and model-based cost-effectiveness analyses, expressed in incremental cost per QALY (quality-adjusted life year). The model will be designed to associate the frailty at the end of follow-up with further expected healthcare expenses beyond the duration of the trial. Statistical analysis will be blinded to group allocation, and outcome assessors will be blinded to the maximal extent possible.
Ethics approval has been obtained from the Medical Ethics Committee of UZ Brussel (O.G. 016), Peer reflection group Biomedical Ethics, Laarbeeklaan 101, 1090 Brussels. Results will be disseminated in publications and other relevant platforms. This study was registered at Clinicaltrials.gov on 6 July 2023 and posted on 14 July 2023 after National Library of Medicine quality control review. Registration details: NCT05946109
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