Effectiveness and cost-effectiveness of a combined lifestyle intervention compared with usual care for patients with early-stage knee osteoarthritis who are overweight (LITE): protocol for a randomised controlled trial
| Autor: | Nuria E J Jansen, Dieuwke Schiphof, Edwin Oei, Judith Bosmans, Jolande van Teeffelen, Anita Feleus, Jos Runhaar, Joyce van Meurs, Sita M A Bierma-Zeinstra, Marienke van Middelkoop |
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| Přispěvatelé: | General Practice, Radiology & Nuclear Medicine, Internal Medicine, Orthopedics and Sports Medicine, Health Economics and Health Technology Assessment, APH - Mental Health, APH - Methodology |
| Jazyk: | angličtina |
| Rok vydání: | 2022 |
| Předmět: |
clinical trials
Cost-Benefit Analysis knee General Medicine Middle Aged Osteoarthritis Knee Overweight primary care SDG 3 - Good Health and Well-being Pragmatic Clinical Trials as Topic Weight Loss Quality of Life Humans Multicenter Studies as Topic musculoskeletal disorders Life Style Aged Randomized Controlled Trials as Topic |
| Zdroj: | BMJ Open, 12(3). BMJ Publishing Group BMJ Open, 12(3):e059554, 1-11. BMJ Publishing Group Jansen, N E J, Schiphof, D, Oei, E, Bosmans, J, van Teeffelen, J, Feleus, A, Runhaar, J, van Meurs, J, Bierma-Zeinstra, S M A & van Middelkoop, M 2022, ' Effectiveness and cost-effectiveness of a combined lifestyle intervention compared with usual care for patients with early-stage knee osteoarthritis who are overweight (LITE): protocol for a randomised controlled trial ', BMJ Open, vol. 12, no. 3, e059554, pp. 1-11 . https://doi.org/10.1136/bmjopen-2021-059554 |
| ISSN: | 2020-0943 2044-6055 |
| Popis: | IntroductionObesity is the most important modifiable risk factor for knee osteoarthritis (KOA). Especially in an early stage of the disease, weight loss is important to prevent further clinical and structural progression. Since 2019, general practitioners (GPs) in the Netherlands can refer eligible patients to a combined lifestyle intervention (GLI) to promote physical activity, healthy nutrition and behavioural change. However, GPs scarcely refer patients with KOA to the GLI potentially due to a lack of evidence about the (cost-)effectiveness. The aim of this study is to determine the (cost-)effectiveness of the GLI for patients with early-stage KOA in primary care.Methods and analysisFor this pragmatic, multi-centre randomised controlled trial, 234 participants (aged 45–70 years) with National Institute for Health and Care Excellence (NICE) guideline diagnosis of clinical KOA and a body mass index above 25 kg/m2will be recruited using a range of online and offline strategies and from general practices in the Netherlands. Participants will receive nine 3-monthly questionnaires. In addition, participants will be invited for a physical examination, MRI assessment and blood collection at baseline and at 24-month follow-up. After the baseline assessment, participants are randomised to receive either the 24-month GLI programme in addition to usual care or usual care only. Primary outcomes are self-reported knee pain over 24 months, structural progression on MRI at 24 months, weight loss at 24 months, as well as societal costs and Quality-Adjusted Life-Years over 24-month follow-up. Analyses will be performed following the intention-to-treat principle using linear mixed-effects regression models.Ethics and disseminationEthical approval was obtained through the Medical Ethical Committee of the Erasmus MC University Medical Center Rotterdam, The Netherlands (MEC-2020-0943). All participants will provide written informed consent. The results will be disseminated through publications in peer-reviewed journals, presentations at international conferences and among study participants and healthcare professionals.Trial registration numberNetherlands Trial Registry (NL9355). |
| Databáze: | OpenAIRE |
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