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Trial registered on ANZCTR


Registration number
ACTRN12625000050459
Ethics application status
Approved
Date submitted
18/10/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Resilience And Healthy Lifestyle for Rheumatoid Arthritis
Scientific title
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.
Secondary ID [1] 312938 0
None
Universal Trial Number (UTN)
N/A
Trial acronym
RA-HEAL
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid arthritis 335103 0
Condition category
Condition code
Inflammatory and Immune System 331678 331678 0 0
Rheumatoid arthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.

Intervention code [1] 329540 0
Treatment: Other
Intervention code [2] 329541 0
Lifestyle
Intervention code [3] 329542 0
Behaviour
Comparator / control treatment
Program B. Best practice usual care by treating medical professionals in combination with any additional RA-relevant services initiated by the participant such as seeking information from the internet or by contacting specialised organisation such as Arthritis Queensland.
Control group
Active

Outcomes
Primary outcome [1] 340201 0
Health-related physical quality of life
Timepoint [1] 340201 0
Baseline, 6 months (end of study, primary time point), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [1] 443258 0
Exercise Capacity
Timepoint [1] 443258 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [2] 443259 0
Neuromuscular Power and Agility
Timepoint [2] 443259 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [3] 443260 0
Neuromuscular Strength
Timepoint [3] 443260 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [4] 443261 0
Neuromuscular Strength Endurance
Timepoint [4] 443261 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [5] 443262 0
Weekly physical activity and sitting time
Timepoint [5] 443262 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [6] 443263 0
Body mass index
Timepoint [6] 443263 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [7] 443264 0
Abdominal weight distribution
Timepoint [7] 443264 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [8] 443265 0
Health-related mental quality of life
Timepoint [8] 443265 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [9] 443266 0
Mental Wellbeing
Timepoint [9] 443266 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [10] 443267 0
Psychological Stress
Timepoint [10] 443267 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [11] 443268 0
Confidence and perceived capability to self manage exercise, wellbeing, healthy eating, non smoking and medication
Timepoint [11] 443268 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [12] 443269 0
Social support received
Timepoint [12] 443269 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [13] 443270 0
Quality of Life
Timepoint [13] 443270 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [14] 443271 0
Usual dietary intake, cooking behaviours
Timepoint [14] 443271 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [15] 443272 0
Adherence to a Mediterranean style diet
Timepoint [15] 443272 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [16] 443273 0
Disease activity
Timepoint [16] 443273 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [17] 443274 0
Disease activity
Timepoint [17] 443274 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [18] 443275 0
Disease activity
Timepoint [18] 443275 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [19] 443276 0
Cardiovascular disease risk
Timepoint [19] 443276 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [20] 443277 0
Smoking status
Timepoint [20] 443277 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [21] 443278 0
Smoking status
Timepoint [21] 443278 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)
Secondary outcome [22] 443279 0
Participation & engagement
Timepoint [22] 443279 0
2 (end of resilience training) and 6 months (end of intervention)
Secondary outcome [23] 443280 0
Participants' experience
Timepoint [23] 443280 0
2 (end of resilience training) and 6 months (end of intervention)
Secondary outcome [24] 443281 0
Participants' experience
Timepoint [24] 443281 0
6 months
Secondary outcome [25] 443282 0
Additional professional assistance seeking
Timepoint [25] 443282 0
Baseline, 6 months (end of study), 12,18 and 24 months (maintenance follow-up)

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer-generated randomisation table held centrally by the senior statistician and data manager (concealed group allocation)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation in blocks of 4, stratified for current smoking history to ensure similar representation in each arm, and allocated 1:1 to one of two groups
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Statistical analysis will be performed on an intention to treat basis. Before modelling trial outcomes, demographic and clinical characteristics of the intervention and control group participants will be examined to establish the extent to which randomisation succeeded in creating comparable groups. If any characteristics are not comparable at baseline, they will be modelled as covariates in subsequent analyses to adjust for possible confounding effects.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/02/2025
Actual
Date of last participant enrolment
Anticipated
27/02/2026
Actual
Date of last data collection
Anticipated
28/02/2028
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 27249 0
Princess Alexandra Hospital - Woolloongabba
Recruitment postcode(s) [1] 43331 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 317373 0
Government body
Name [1] 317373 0
Australian Department of Health and Aged care - Medical Research Future Fund
Country [1] 317373 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 319661 0
Government body
Name [1] 319661 0
Metro South Hospital and Health Service
Address [1] 319661 0
Country [1] 319661 0
Australia
Other collaborator category [1] 283256 0
University
Name [1] 283256 0
Griffith University
Address [1] 283256 0
Country [1] 283256 0
Australia
Other collaborator category [2] 283257 0
Charities/Societies/Foundations
Name [2] 283257 0
Arthritis Queensland
Address [2] 283257 0
Country [2] 283257 0
Australia
Other collaborator category [3] 283258 0
University
Name [3] 283258 0
University of Sydney
Address [3] 283258 0
Country [3] 283258 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316102 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 316102 0
Ethics committee country [1] 316102 0
Australia
Date submitted for ethics approval [1] 316102 0
10/06/2024
Approval date [1] 316102 0
11/09/2024
Ethics approval number [1] 316102 0
HREC/2024/QMS/108789

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 136786 0
Dr Amee Sonigra
Address 136786 0
Princess Alexandra Hospital, Ipswich Rd, Buranda QLD 4102
Country 136786 0
Australia
Phone 136786 0
+61 409 774 448
Fax 136786 0
Email 136786 0
[email protected]
Contact person for public queries
Name 136787 0
Michelle Roch
Address 136787 0
Frazer Institute, Level 6, Translational Research Institute, 37 Kent Street, Woolloongabba QLD 4102
Country 136787 0
Australia
Phone 136787 0
+61 7 3443 6956
Fax 136787 0
Email 136787 0
[email protected]
Contact person for scientific queries
Name 136788 0
Professor Ranjeny Thomas
Address 136788 0
Frazer Institute, Level 6, Translational Research Institute, 37 Kent Street, Woolloongabba QLD 4102
Country 136788 0
Australia
Phone 136788 0
+61 7 3443 6960
Fax 136788 0
Email 136788 0
[email protected]

Data sharing statement
Will there be any conditions when requesting access to individual participant data?
Yes
Data Eligibility and Access Conditions?
Who is eligible to request access to the individual participant data?
Other
Available only to researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of Primary Sponsor

Would there be any conditions for requesting access to individual participant data?
Other
-

What individual participant data will be or are expected to be shared?
Other
Individual participant data underlying published results

What types of analyses could be conducted using the individual participant data?
Other
For any purpose

When might the individual participant data become available to request access, and for how long?
From:
Other
From 3 months after publication; no end dat

To:
Other
-

Where can requests to access individual participant data be made, or data be obtained directly?
Other
Access subject to approvals by Principal Investigator ([email protected])

Are there additional conditions or steps involved in requesting or accessing individual participant data?
No
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
From 3 months after publication; no end date
Available to whom?
Available only to researchers who provide a methodologically sound proposal, on a case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
For any purpose
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.