Resilience And Healthy Lifestyle for Rheumatoid Arthritis (The RA-HEAL trial): a randomised, parallel group, placebo-controlled clinical trial protocol.
Katherine A Poulsen, Nicola W Burton, Hannah L Mayr, Veronique S Chachay, Jeff S Coombes, Coral E Gartner, Amee Sonigra, Paul Christensen, Karl A Hansford, Dianna J Ang, Jessica Neri, Ramali Mendis, Tom Lynch, Cheryl Dines, Helen Benham, Aoife Sweeney, Lyn M March, Asaduzzaman Khan, Haitham Tuffaha, Ranjeny Thomas
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引用次数: 0
Abstract
Background: The importance of self-management strategies that optimise physical health and mental health in the management of rheumatoid arthritis (RA) is recognised, but access to multidisciplinary teams to support this can be challenging. Furthermore, evidence for the impact of multidisciplinary interventions, especially in early RA, is lacking.
Methods: The Resilience and Healthy Lifestyle for Rheumatoid Arthritis (RA-HEAL) Trial is a pragmatic RCT that aims to compare the effects of a structured multidisciplinary lifestyle intervention with self-directed activities in best-practice usual care. The 20-week multi-modal intervention incorporates structured resilience training conducted by a clinical health psychologist (CHP), followed by an exercise physiologist (EP)-led exercise programme, dietary education conducted by a dietitian nutritionist (DN), a smoking cessation programme (where applicable) and psychologist-led behaviour-change support. The comparison group will receive written information on a healthy lifestyle in accordance with standard best practice care. The primary outcome is health-related quality of life (QoL) at 6 months.
Discussion: RA-HEAL tests whether a tailored intervention including formal resilience training with a clinical psychologist followed by Mediterranean diet, exercise, smoking cessation and behaviour change support has a greater effect on health-related QoL at 6 months than written advice given in current best-practice settings. QoL is a composite endpoint that is highly valued by patients with RA. RA-HEAL is unique in that it targets RA within 12 months of onset. RA-HEAL's linkage with the Australian Autoimmune Arthritis Biobank Cooperative (A3BC) supports 6 monthly follow-up data and biosampling to 24 months post-intervention and linkage to health data collections, creating a valuable resource for future research and the potential to determine medium and long-term effects of behaviour change. In its secondary outcomes, RA-HEAL will analyse the longevity of effects of intervention or best-practice usual care for up to 2 years and cost utility. The outcomes should provide evidence to underpin a scalable approach to support people with newly diagnosed RA.
Trial registration: ACTRN12625000050459, ANZCTR. Registered on 20 January 2025.
期刊介绍：
Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.
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