Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622000507785
Ethics application status
Approved
Date submitted
22/03/2022
Date registered
30/03/2022
Date last updated
30/03/2022
Date data sharing statement initially provided
30/03/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effects of a Wellbeing and Healthy Lifestyle Program for People with Rheumatoid Arthritis
Scientific title
Effects of a Wellbeing and Healthy Lifestyle Program for People with Rheumatoid Arthritis
Secondary ID [1] 306688 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Rheumatoid Arthritis 325634 0
Poor Wellbeing/Quality of Life 325635 0
Physical Inactivity 325655 0
Unhealthy Diet 325656 0
Cigarette Smoking 325657 0
Condition category
Condition code
Inflammatory and Immune System 322994 322994 0 0
Rheumatoid arthritis
Mental Health 323003 323003 0 0
Other mental health disorders
Physical Medicine / Rehabilitation 323004 323004 0 0
Other physical medicine / rehabilitation
Diet and Nutrition 323005 323005 0 0
Other diet and nutrition disorders
Public Health 323009 323009 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The program will be delivered over 20 weeks by a multidisciplinary team with expertise and training in Clinical/Health Psychology (CHP), Exercise Physiology (EP), Nutrition and Dietetics (ND), and Tobacco Treatment Specialisation (TTS). Sessions will be at a university campus and include individual (in person and teleconference) and small group (n=3-5) in person sessions to provide education, skills training, feedback, relevant resources and support. Individual assessments and planning sessions will be conducted to understand participant habits, contexts and preferences to tailor the lifestyle component programming.

Resilience Training is provided first (weeks 1-8) to introduce concepts, provide support on the impact of RA and to provide a foundation for coping strategies relevant across the other components. The smoking cessation component (where indicated) begins in week 5. The exercise and healthy components run concurrently in weeks 9-16. The behaviour change counselling commences in week 11.

Resilience Training (6 x 2 hr group sessions over 8 weeks). This group component is first to introduce 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 sessions. Sessions focus on the role of wellbeing in RA self-management, mindfulness, acceptance, cognitive flexibility, life values and meaningful actions, accessing support, sleep and pleasurable activities. Sessions will make explicit links to relevance to lifestyle behaviours. Adherence will be assessed by interventionist records of participant attendance at sessions.

Exercise Training (75mins individual planning session, 8 x 40 minutes small group training sessions, with 2 sessions per week on alternating weeks over 7 weeks). Individualised prescription is based on medical history, interests, limitations and suitability for self-direction. Small group supervised training targets recommendations of >150 mins/week of moderate or 75 mins/week of vigorous aerobic exercise, and muscle strengthening exercise. The aerobic training focuses on walking, and strength exercises will involve upper and lower limbs using body weight, fitball, therabands and small weights available in the home. Pool exercises may also be included if walking is challenging. Training intensity progresses according to participant preferences and ability. Intensity will be monitored using an approach that uses both heart rate monitors and RPE. Participants are provided with fitbits for behavioural monitoring and these also provide information on heart rate which can be used during supervised and self directed exercise training. Participants are supported to self-direct exercise, and be given a Fitbit for self-monitoring, exercise mat, fitball and therabands. Adherence will be assessed by interventionist records of participant attendance at sessions.

Nutrition Counselling (45mins individual planning session, 4 x 30 minutes individual telephone sessions, on alternating weeks over 7 weeks). An interview, questionnaire based on intake of core food groups ( Mediterranean Diet Adherence Score) and data from a 3 day food diary (online app) is used to determine habitual dietary intake, including diet quality, eating pattern, food preferences, and alcohol intake. Energy requirements are estimated. Nutrition counselling focuses on personalised goals to target ideal weight balance and diet quality, based on healthy eating recommendations, and current evidence about pro and anti-inflammatory food constituents. Participants are provided with resources to guide food shopping, meal preparation, and target daily intake. Individualised “check-ins” where family are invited too, will assist in trouble-shooting of “road-blocks”. During two of these check in sessions with intervention participants, individualised dietary intake will be monitored by an interviewer assisted 24-hour recall interview. Adherence will be assessed by interventionist records of participant attendance at sessions.

Behaviour Change Counselling (4 x 1 hour small group sessions on alternating weeks over 8 weeks). Small group-based sessions support lifestyle change advice. This is based on the 5A Behavioural Counselling Framework as an evidence-based approach appropriate for people with chronic conditions. Key components are (i) Assessment: e.g., perceived role of lifestyle in RA, experiences/barriers/enablers of change. (ii) Advice: clear recommendations. (iii) Agree: Collaborative goal setting; (iv) Assistance: Cognitive and behavioural strategies to support change (e.g., action planning, positive outcome expectations, problem-solving, adaptive interpretation of setbacks). (v) Arrange: Additional assistance/resources. Adherence will be assessed by interventionist records of participant attendance at sessions.

Smoking Cessation Counselling (2 hour small group session, 45mins individual planning session, 5 x 15mins individual telephone sessions weekly over 5 weeks). (where indicated) An initial face to face small group session (n=3-5) is used to provide basic psychoeducation and smoking cessation principles. Individualised sessions include nicotine dependence assessment, quitting self-efficacy, carbon monoxide monitoring, lung age calculator, individual Quit Plan, education, support, and practical coping strategies. Participants are asked to personally arrange an appointment with a GP of their choice for a prescription for pharmacotherapy if they want to use prescription smoking cessation medication for their quit attempt. Over the counter stop smoking medications (Nicotine Replacement Therapy) are supplied as indicated and correct use demonstrated. Dosing is based on WHO “first line therapy” and RACGP guidelines. Prescription medicine options (Varenicline and Bupropion) will be supported in line with participant preferences and in consultation with the medical team. Adherence will be assessed by interventionist records of participant attendance at sessions.
Intervention code [1] 323136 0
Lifestyle
Intervention code [2] 323141 0
Treatment: Other
Comparator / control treatment
This will include usual contacts with treating professionals and written information on the value of good mental health and a healthy lifestyle for RA. People managed with cDMARds and bDMARDs attend RA and Biologics clinics every 3-6 months as usual
Control group
Active

Outcomes
Primary outcome [1] 330758 0
Wellbeing is assessed using the Personal General Wellbeing Index, which is administered as an online questionnaire



Timepoint [1] 330758 0
Within one month after program completion
Primary outcome [2] 330759 0
Quality of Life is assessed using the SF36 Mental and Physical Components of the SF-36 which is administered as an online questionnaire
Timepoint [2] 330759 0
Within one month after program completion
Primary outcome [3] 330769 0
Physical activity (time spent in activity in the past week) is assessed via self report using National Health Survey items via an online questionnaire
Timepoint [3] 330769 0
Within one month after program completion
Secondary outcome [1] 407464 0
PRIMARY OUTCOME: Physical activity (time spent in activity in the past week) assessed objectively via accelerometry over one week
Timepoint [1] 407464 0
Within one month after program completion
Secondary outcome [2] 407487 0
PRIMARY OUTCOME: Diet quality assessed via a telephone administered dietary intake interview and questionnaire (Mediterranean Diet Adherence Score: https://predimedplus.com/en/), and data from a 3 day online food diary (Research Food Diary- Xyris Software)
Timepoint [2] 407487 0
Within one month after program completion
Secondary outcome [3] 407494 0
PRIMARY OUTCOME: Smoking cessation assessed by self-report. Online questionnaire items assess cigarettes smoked, nicotine dependence, quitting self-efficacy i.e. confidence about making another quit attempt.
Timepoint [3] 407494 0
Within one month after program completion
Secondary outcome [4] 407495 0
Physical function is assessed using 6-Minute Walk Test (6MWT) as a measure of exercise capacity. If assessment is moved online, the 2min Step in Place Test will be used.
Timepoint [4] 407495 0
Within one month after program completion
Secondary outcome [5] 407496 0
Neuromuscular strength is assessed using grip strength with a dynamometer. If assessment is done online, this will be dropped.
Timepoint [5] 407496 0
Within one month after program completion
Secondary outcome [6] 407497 0
Physical power is assessed using the Timed-Up & Go test (TUG) . If assessment is done online, the TUG will be dropped
Timepoint [6] 407497 0
Within one month after program completion
Secondary outcome [7] 407941 0
Physical strength endurance is assessed using the 30s Sit to Stand Test. If assessment is done online, the 2min Step in Place Test will be used instead.
Timepoint [7] 407941 0
Within one month after program completion
Secondary outcome [8] 407942 0
Anthropometry including assessor-based measures of (i) height and weight to derive body mass index (BMI) and (ii) girths (waist, hip) using standard protocols. If assessment is done online, participants will be asked to self report height and weight, and may be mailed a tape measure for guided self assessment of girths.
Timepoint [8] 407942 0
Within one month after program completion
Secondary outcome [9] 407943 0
Fidelity of intervention implementation is assessed using feedback from the interventionists regarding delivery against protocol.
Timepoint [9] 407943 0
Written will be obtained from interventionists within two months after program completion, using questionnaires designed specifically for this project. Interventionists will also be invited to provide verbal feedback in a semi structured 1-1 interview
Secondary outcome [10] 407944 0
Feasibility is assessed using study records to determine the proportion of people recruited to the trial as a function of a priori targets; and attendance records to determine the proportion of participants (allocated to the intervention condition) attending program sessions as a function of the number of scheduled sessions, and the proportion of participants (allocated to the intervention condition) completing the program as a function of the number enrolled.
Timepoint [10] 407944 0
Assessment will be conducted during the program, aligning with program components and sessions.
Secondary outcome [11] 407945 0
Acceptability is assessed via participant online questionnaires specifically designed for this study. Items assess satisfaction with and perceived helpfulness of the program overall and specific program components, as well as the mode, duration, and frequency of program sessions.
Timepoint [11] 407945 0
Within one month after program completion
Secondary outcome [12] 407951 0
Safety is assessed as the number of adverse study related events and adverse consequences related to the program targets. Potential examples include exercise-related injury, disease exacerbation, adverse reactions to smoking cessation aids. This will be assessed via participant self report in response to interventionist verbal queries monitoring during program sessions (for those allocated to the intervention condition), and participant self report on the post intervention questionnaire (all participants).
Timepoint [12] 407951 0
Information on adverse events will be collated from participants via verbal self report in response to interventionist verbal queries during program sessions and individual follow up after sessions as required (for those allocated to the intervention), and on the post intervention questionnaire (all participants) using items specifically designed for this study.

Eligibility
Key inclusion criteria
Participants are adults with a diagnosis of RA according to 2010 criteria, where the disease has been managed with conventional or biologic disease modifying drugs (cDMARDs, bDMARDs).
(i) living in Brisbane area and able to access intervention site as scheduled, (ii) ambulatory, (iii) willing to attempt change in lifestyle behaviours as an adjunct to RA medication.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
(i) medical conditions contraindicated to exercise training (e.g., unstable angina) (ii) significant lower limb musculoskeletal impairment preventing stationary cycling use in assessment (iii) current or intended attendance in other similar program (iv) receiving psychiatric/psychological treatment (counselling or pharmacological) (v) other autoimmune condition (e.g. Celiac disease, inflammatory bowel disease).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer generated assignment
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation with stratified allocation by cigarette smoking status.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Between group differences will be assessed using intention to treat analyses and generalized linear mixed-effect models (GLMMs) adjusting for baseline value on the outcome variables and covariates. These models are the most efficient and recommended method for analysing longitudinal clinical trial data and can account for data missing at random without the need to perform explicit imputations of the missing values. Interaction between group and time will be examined in order to test whether groups are acting differently depending on the time points.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
14/03/2022
Date of last participant enrolment
Anticipated
30/04/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
25
Accrual to date
6
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 21968 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 21969 0
Logan Hospital - Meadowbrook
Recruitment postcode(s) [1] 37064 0
4102 - Woolloongabba
Recruitment postcode(s) [2] 37065 0
4131 - Meadowbrook

Funding & Sponsors
Funding source category [1] 311019 0
Charities/Societies/Foundations
Name [1] 311019 0
Arthritis Australia
Country [1] 311019 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Griffith University
170 Kessels road
Nathan Qld 4111
Country
Australia
Secondary sponsor category [1] 312335 0
Hospital
Name [1] 312335 0
Metro South Hospital and Health Services
Address [1] 312335 0
Metro South Health
Building 5
Garden City Office Park
2404 Logan road
Eight Mile Plains Qld 4113
Country [1] 312335 0
Australia
Secondary sponsor category [2] 312344 0
University
Name [2] 312344 0
The University of Queensland
Address [2] 312344 0
St Lucia QLD 4072
Country [2] 312344 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310566 0
Metro South Hospital and Health Service - Metro South Human Research Ethics Committee
Ethics committee address [1] 310566 0
Metro South Research Ethics
Metro South Health
Building 5 Garden City Office Park
2404 Logan Rd, Eight Mile Plains QLD 4113
MSH-Ethics@health.qld.gov.au
Ethics committee country [1] 310566 0
Australia
Date submitted for ethics approval [1] 310566 0
08/12/2020
Approval date [1] 310566 0
18/12/2020
Ethics approval number [1] 310566 0
HREC/2020/QMS/70435
Ethics committee name [2] 310572 0
Griffith University Human Research Ethics Committee
Ethics committee address [2] 310572 0
Griffith University Office for Research
170 Kessels Rd
Nathan Qld 4111
Ethics committee country [2] 310572 0
Australia
Date submitted for ethics approval [2] 310572 0
13/09/2021
Approval date [2] 310572 0
16/09/2021
Ethics approval number [2] 310572 0
2021\684
Ethics committee name [3] 310573 0
University of Queensland Human Ethics Committee
Ethics committee address [3] 310573 0
University of Queensland
St Lucia QLD 4102
Ethics committee country [3] 310573 0
Australia
Date submitted for ethics approval [3] 310573 0
17/09/2021
Approval date [3] 310573 0
17/09/2021
Ethics approval number [3] 310573 0
2021/HE001971

Summary
Brief summary
The aim of this project is to evaluate the impact, feasibility, acceptability of a wellbeing and healthy lifestyle program for adults with rheumatoid arthritis (RA). The program is delivered over 20 weeks by a multidisciplinary team and includes individual (in person and online/teleconference) and small group in person sessions to provide education, skills training, feedback, resources and support related to psychological resilience, exercise, healthy eating, cigarette smoking cessation and behaviour change. Assessment is done before and within 1 month after the program using online questionnaires, measures of physical functioning, a dietary interview and food diary, and physical activity monitoring. Questionnaires will be used to assess participant feedback on the program. It is hypothesised that program participants will describe the program positively and show more improvements in wellbeing, healthy lifestyle behaviours and physical functioning than those receiving usual care. The outcomes of this research will be used to review and revise the program and to design a larger trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 118110 0
A/Prof Nicola Burton
Address 118110 0
Griffith University School of Applied Psychology
176 Messines Ridge Rd
Mount Gravatt QLD 4122
Country 118110 0
Australia
Phone 118110 0
+61 7 37353315
Fax 118110 0
Email 118110 0
n.burton@griffith.edu.au
Contact person for public queries
Name 118111 0
A/Prof Nicola Burton
Address 118111 0
Griffith University School of Applied Psychology
176 Messines Ridge Rd
Mount Gravatt QLD 4122
Country 118111 0
Australia
Phone 118111 0
+61 7 37353315
Fax 118111 0
Email 118111 0
n.burton@griffith.edu.au
Contact person for scientific queries
Name 118112 0
A/Prof Nicola Burton
Address 118112 0
Griffith University School of Applied Psychology
176 Messines Ridge Rd
Mount Gravatt QLD 4122
Country 118112 0
Australia
Phone 118112 0
+61 7 37353315
Fax 118112 0
Email 118112 0
n.burton@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
No individual participant data shared due to ethics restrictions.
This is a pilot study to inform intervention program development and implementation, and a larger randomised controlled trial.


What supporting documents are/will be available?

Current supporting documents:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15431Study protocol  n.burton@griffith.edu.au 383763-(Uploaded-17-03-2022-10-50-23)-Study-related document.doc
15432Informed consent form  n.burton@griffith.edu.au 383763-(Uploaded-17-03-2022-10-55-46)-Study-related document.docx
15433Ethical approval  n.burton@griffith.edu.au 383763-(Uploaded-17-03-2022-10-56-07)-Study-related document.pdf


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15431Study protocol  n.burton@griffith.edu.au 383763-(Uploaded-02-03-2023-10-20-41)-Study-related document.doc
15432Informed consent form  n.burton@griffith.edu.au 383763-(Uploaded-02-03-2023-10-20-41)-Study-related document.docx
15433Ethical approval  n.burton@griffith.edu.au 383763-(Uploaded-02-03-2023-10-20-42)-Study-related document.pdf

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.