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Resilience And Healthy Lifestyle for Rheumatoid Arthritis

An open label pragmatic randomised controlled clinical trial to assess the effects on health-related quality of life of wellbeing and healthy lifestyle interventions relative to best practice usual care for people with new-onset rheumatoid arthritis.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000050459
Acronym
RA-HEAL
Enrollment
10
Registered
2025-01-20
Start date
2025-05-21
Completion date
2026-02-27
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Rheumatoid arthritis (RA) is currently an incurable disease of ageing. Self-management - including good mental health, exercise, a healthy diet, and smoking cessation - complements medical management. The RA-HEAL program is a six-month multidisciplinary, person-centred, blended-delivery program combining resilience, healthy lifestyle behaviours and change support for RA. The RA-HEAL trial builds on a successful pilot study to assess real-world effectiveness of RA-HEAL compared to best practice usual care in people newly diagnosed with RA. The primary outcome is health-related quality of life. Effects of the intervention, relative to standard care, on physical function, mental wellbeing, lifestyle behaviours and disease control will be evaluated at 6, 12, 18 and 24 months of follow-up. Feasibility, safety, acceptability and value for money will also be evaluated. This research will provide evidence to support a nationally-scalable approach to enable RA self-management to ultimately reduce the individual and public health burden of RA associated with distress, poor physical function, long-term complications and healthcare costs.

Interventions

This research is comparing two different programs designed to help people with arthritis. One is a structured program (Program A), and the other is self-directed (Program B). Both programs focus on lifestyle and wellbeing including exercise, healthy eating and emotional wellbeing. Each program includes continuous medical care from the participant’s chosen doctor, as well as regular extra assessment and follow-up with the research team. All participants in Program A and Program B will receive u

This research is comparing two different programs designed to help people with arthritis. One is a structured program (Program A), and the other is self-directed (Program B). Both programs focus on lifestyle and wellbeing including exercise, healthy eating and emotional wellbeing. Each program includes continuous medical care from the participant’s chosen doctor, as well as regular extra assessment and follow-up with the research team. All participants in Program A and Program B will receive usual contact with treating medical professionals and any additional RA-relevant services initiated by the participant: once stable, patients managed with conventional or biological disease-modifying anti-rheumatic drug (DMARDs) typically attend rheumatologist appointments every 3-6 months. At the baseline assessment, participants will receive written information about: 1. General principles of RA self-management including wellbeing and a healthy lifestyle (resources from Arthritis Queensland website) 2. Arthritis QLD support networks: self-management support and services such as online exercise groups 3. Factsheet about healthy eating and arthritis (resources from Arthritis Queensland website) 4. The Quitline resource for smoking cessation when relevant All participants will be followed-up every 6 months up to 24 months after the initial 6 months intervention time (group A- RA-HEAL) Program A: RA-HEAL Intervention Program A participants will take part in the RA-HEAL program. It will be delivered over 6 months, comprising five partially overlapping multidisciplinary person-centered interventions designed to recognise individual preferences, values, and concerns; with shared decision making, empowerment, and physical and emotional support. RA-HEAL will be delivered as a combination of one-on-one or group in-person and online sessions, with oversight from associate investigators specialists in their discipline (psychology, exercise science, nutrition and dietetics , smoking cessation). Participants will be able to select their preferred location and time from the multiple time options offered. Online and in person groups will be capped at 10 people. If the participant is randomised and attends at least 25% of the sessions from all components, they will be analysed per Intention-to-Treat principle. Participants will complete the full intervention schedule of resilience training, exercise, diet, smoking cessation (if relevant) and behaviour change support over a 20 week period. Participants will complete the resilience component first, attending one session per week for eight weeks – total commitment: 14 hr (weeks 1 to 8). Thereafter, participants commence the exercise, diet and optionally smoking cessation sessions in parallel. Exercise sessions will be offered for eight weeks to enable completion of eight in-person sessions (1 h each) in combination with twelve online sessions (1 h each) – total commitment: 20 hr (weeks 9 to 16). Concurrent to this, diet sessions will run for 5 weeks, enabling participation in up to six consultation sessions – total commitment: 5 hr (weeks 9 to 16). Therefore, for non-smokers, the total time commitment during weeks 9 to 16 would be 25 hr. For smoking participants, the smoking cessation intervention will also run concurrent to diet and exercise. This will involve attendance at seven sessions over seven weeks – total commitment: 7 hr (weeks 9 to 16). Therefore, for smoking participants, their total time commitment during weeks 9 to 16 would be 32 hr. Finally, participants attend behaviour change support sessions for four weeks – total commitment: 4 hr (during weeks 17-20). Excluding questionnaires and hospital visits, the total minimum time for each participant to complete the full intervention schedule is 43 hr, and optionally 50 hr for smoking participants. Psychosocial Resilience Training Comprising 6 × 2hr in-person and 2 × 1hr online group sessions delivered by a clinical health psychologist, This group component is scheduled at the beginning to introduce key concepts, provide support on the impact of RA, and to provide a foundation for coping strategies relevant across the other components. Participants will have the option to invite a significant other to the sessions. Drawing from Acceptance and Commitment Therapy, Cognitive Behaviour Therapy and Behaviour Activation principles, sessions will focus on the role of mental health in RA self-management, mindfulness, acceptance, cognitive flexibility, life values and meaningful actions, accessing support, sleep and pleasurable activities. Sessions will include information giving, experiential activities, and applied practice “homework”. Sessions commence weekly and progress to a fortnightly schedule. Adherence will be monitored with session attendance checklists. Exercise Training Participants will attend group exercise training sessions 1×/week in person and 1×/week online for the first 8 weeks post resilience training, and then weekly online for the next month. Each session will be conducted with an exercise physiologist, targeting recommendations of >150 mins/wk of moderate to vigorous aerobic exercise and muscle strengthening exercise. Aerobic exercise will focus on walking unless symptoms adversely impact on this mode, in which case suitable alternatives will be identified based on participant capabilities and access to resources. Strength exercises will involve upper and lower limbs using body weight, Fitball (supplied), Therabands (supplied) and small weights (supplied) for use on site and at home. In week 1, participants undertake a 1-hour individual session for assessment of goals and preferences. Individualised exercise prescription will be based on medical history, interests/preferences, physical capacity, and suitability for self-direction. Adherence will be monitored with session attendance checklists and app analytics. Nutrition Counselling The nutrition counselling will take place over a 12-week period (months 3 to 5 of the program). In week 1 post resilience training, participants undertake a 1-hour individual consultation via teleconference for nutrition assessment and personalised goal setting. 30-minute individual follow-up consultations will then take place in weeks 3 and 12. Additionally, 3 x 1-hour virtual group sessions will be offered at different times, approximately occurring in weeks 5, 7 and 9 to provide nutrition education and practical strategies including related to swapping or replacing foods, food preparation and recipes, label reading and shopping and eating out. Individual and group sessions will be delivered by an Accredited Practising Dietitian and will recommend alignment with a Mediterranean-style diet, including higher intake of foods with anti-inflammatory properties (vegetables, fruits, nuts, legumes, fish, whole grains, herbs/spices, extra virgin olive oil), and lower intake of pro-inflammatory or ultra-processed foods, (e.g., biscuits, confectionery, processed meats, red meat, sugary drinks). Recommendations will be individualised and tailored resources which align with the recommendations (e.g. from Nutrition Education Materials Online and National Heart Foundation) will be provided where appropriate. Adherence will be monitored with session attendance checklists. Smoking Cessation In week 1 post resilience training, a group education session will be conducted online, followed by 5×/weekly individual telehealth follow-ups. Sessions will be delivered by a tobacco treatment specialist and include nicotine dependence assessment, quitting self-efficacy, lung age calculator, individual Quit Plan, education, support, and practical coping strategies. Over-the-counter stop smoking Nicotine Replacement Therapy options will be recommended and use demonstrated. Dosing is based on WHO “first line therapy” and RACGP guidelines, including combination patches plus oral nicotine replacement, which is one of the most successful approaches to quit smoking. Prescription Varenicline and Bupropion options will be supported in line with participant preferences, in consultation with the patient’s usual rheumatologist or GP. Adherence will be monitored with session attendance checklists and exhaled CO monitoring. Behaviour Change Support 4×/1hr online group sessions will be delivered every 2 weeks post resilience training by the same clinical health psychologist. Adherence will be monitored by session attendance checklists. Content is based on the 5A Counselling Framework which is an evidence-based approach appropriate for chronic conditions and endorsed by the The Royal Australian College of General Practitioners and US Task Force on Preventive Health Care. The key components of the 5A framework include: 1. Assessment: perceived value of change, change experiences/barriers/enablers 2. Advice: clear recommendations for change 3. Agree: Collaborative goal setting 4. Assistance: Cognitive and behavioural change strategies e.g. motivational interviewing, action planning, positive expectations, problem-solving, self-monitoring, support, self-beliefs 5. Arrange: Additional assistance/resources as relevant. Program B: Ongoing Best Practice Usual Care Participants will receive the same best practice usual care information to manage rheumatoid arthritis (as listed above) and participate in assessments of physical function, dietary intake, health and quality of life. All participants will also participate in the Australian Arthritis and Autoimmune Biobank Collaborative (A3BC), where their biospecimens (blood sample, mouth swab and stool samples collected every 6 months) and data will contribute to translational research supporting the treatment and prevention of arthritis and autoimmune conditions. At the completion of the study, an online focus group discussion will offer the opportunity to discuss associated barriers and enablers to RA-HEAL engagement and access and implementation of external professional services. All participants in Programs A and B will be given a diary in which to record significant events. They will receive brief monthly contacts (email, telephone) to monitor potential safety events (e.g., falls, injuries), flares, and hospitalisations.

Sponsors

The University of Queensland
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Educational / counselling / training
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Age >= 18 years 2. RA onset in the last 12 months, diagnosed according to 2010 ACR/EULAR 2010 rheumatoid arthritis classification, with management by a rheumatologist with conventional or biologic Disease Modifying Anti-Rheumatic Drugs (DMARDs) 3. Living in Wider Brisbane, Ipswich or Logan area 4. Willing and able to access and participate in all individual AND group program sessions (in-person and online) as an adjunct to RA medication 5. Ambulatory and cleared for participation in an exercise program by a medical practitioner 6. Willing to be enrolled in the Australian Autoimmune Arthritis Biobank Collaborative 8. Able to speak and understand English at a level capable of understanding the informed consent process and fill in the questionnaires

Exclusion criteria

1. Medical conditions contraindicated to exercise training (e.g. unstable angina) 2. Current or intended attendance in program promoting RA self-management 3. Currently receiving psychiatric, psychological, or counselling treatment 4. Other autoimmune condition (e.g., celiac disease, inflammatory bowel disease) 5. Significant lower limb musculoskeletal impairment preventing stationary cycling use in assessment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026