Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000945820
Ethics application status
Approved
Date submitted
10/02/2021
Date registered
19/07/2021
Date last updated
19/07/2021
Date data sharing statement initially provided
19/07/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
A pilot randomised controlled trial: Joint Walkers, a Group of Rheumatology Outdoor Walkers
(GROW Study)
Scientific title
A pilot randomised controlled trial, with embedded qualitative component of, Joint Walkers, a Group of outpatient Rheumatology Outdoor Walkers.
Secondary ID [1] 303201 0
None
Universal Trial Number (UTN)
Trial acronym
GROW Study: Group of Rheumatology Outdoor Walkers
Linked study record

Health condition
Health condition(s) or problem(s) studied:
musculoskeletal pain 322890 0
Condition category
Condition code
Musculoskeletal 318248 318248 0 0
Osteoarthritis
Inflammatory and Immune System 318249 318249 0 0
Autoimmune diseases
Musculoskeletal 318250 318250 0 0
Osteoporosis
Inflammatory and Immune System 318251 318251 0 0
Rheumatoid arthritis
Inflammatory and Immune System 319667 319667 0 0
Connective tissue diseases
Inflammatory and Immune System 319668 319668 0 0
Other inflammatory or immune system disorders
Musculoskeletal 319669 319669 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All patients will receive usual physiotherapy outpatient care.
While the experimental group will be enrolled into “Joint Walkers” an outdoor walking group, 1.25 hours twice a week with a physiotherapist for 3 months, some strength exercises (for example, upper and lower limb exercise with a TheraBand ) will be included.
Flat terrain, seated rests, at patients tolerance, with approximately up to 20 participants. Recording attendance and patient encouraged to self track distances (app/ manually).
Intervention code [1] 319501 0
Treatment: Other
Intervention code [2] 320568 0
Lifestyle
Intervention code [3] 320569 0
Behaviour
Comparator / control treatment
All patients will receive usual physiotherapy outpatient care. In addition, the control group will be referred to "Get Healthy" NSW Government Program, for physical activity coaching, telephone coaching promoting healthy lifestyle including healthy eating, physical activity, weight management and alcohol reduction. Health coach, 10 confidential coaching phone calls, approximately 20min in length each , over six months, motivation and support to set healthy goals, information and journal to help track goals and overcome problems, option for re enrolment after 6 months, free NSW government service.
Control patients will be offered enrolment into Joint Walkers at the completion of the 3-month study duration, while those already attending will be supported to form a self-sustaining maintenance group. All patients will then be re-assessed at 6-months for all outcome measures
Control group
Active

Outcomes
Primary outcome [1] 326230 0
Composite primary outcome of feasibility
Assessed by: number participants recruited each month, proportion of eligible patients recruited per month, retention of participants in both arms of the study and adherence to completion of the intervention.
Timepoint [1] 326230 0
3 & 6 months post commencement of the intervention
Primary outcome [2] 327540 0
Primary clinical outcome: Change in walking activity, as measured using the subscale Walking Activity, using the Incidental and planned exercise questionnaire, version W .
Timepoint [2] 327540 0
3 & 6 months from commencement of treatment
Secondary outcome [1] 390619 0
Achievement of physical activity guidelines, as measured using the Incidental and planned exercise questionnaire, version W
Timepoint [1] 390619 0
3 & 6 months after commencement of the intervention
Secondary outcome [2] 390620 0
Changes in self-efficacy with exercise, as measured using Self-Efficacy with Exercise Scale

Timepoint [2] 390620 0
3 & 6 month after commencement of intervention
Secondary outcome [3] 395608 0
Experiences of Social Cohesion as measured using The Physical Activity Group Environment Questionnaire
Timepoint [3] 395608 0
3 & 6 months after commencement of treatment
Secondary outcome [4] 396852 0
Participant feedback regarding the acceptability of the intervention via a 20 minute open ended phone interview
Timepoint [4] 396852 0
3 months post start of intervention

Eligibility
Key inclusion criteria
• Over the age of 18
• Consulted Rheumatology Physiotherapy service at Liverpool Hospital
• Independently mobile in the community
• Medically cleared to attend Joint Walkers
• Can communicate with staff in English or are able to bring a bilingual support person to their walking session (should they be allocated to this arm)
• Have the cognitive capacity to give informed consent
• Available twice a week to attend a walking group for 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Unable to navigate the community independently
• Unable to safely communicate with staff or bring a bilingual support person.
• Unavailable to attend a walking group twice a week
• Condition medically unstable
• Condition with a prognosis of functionally deterioration over the next 3 months deeming patient unsafe to complete program
• Lack capacity to provide consent

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation using randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Other
Other design features
Pilot randomised controlled trial with embedded Qualitative component
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Comparisons between two therapy groups and within therapy groups will be performed.

Sample size calculations have been based on achieving a large effect size (0.8) difference between the two groups in the primary outcome measure

Primary outcome being amount of walking as per the Incidental and planned exercise, “walking activity” subscale. A sample of 62 patients has been calculated as sufficient to detect , a large effect size of 0.8 a difference of 5.44 walking hours over the weekhours, between the two groups based on previous activity research.
groups assuming the Get Healthy group walk an average of 6.24hrs , SD 6.77hrs in both groups, 80% power , 5% significance with a lost to follow up at 15%, a total of 62 patients.

The Joint walker program feasibility concept will be assessed by documenting: number eligible, number enrolled, attendance rates, and adverse events and the number continuing a self-directed group beyond the 3-month supervised period.
Participants feedback regarding their additional therapy will be documented from interviews

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
6/09/2021
Actual
Date of last participant enrolment
Anticipated
2/05/2022
Actual
Date of last data collection
Anticipated
31/12/2022
Actual
Sample size
Target
62
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18690 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 33127 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 307602 0
Hospital
Name [1] 307602 0
In kind support from Liverpool Hospital
Country [1] 307602 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Liverpool Hospital
Address
Liverpool health services Locked Bag 7103 Liverpool BC NSW 1871
Country
Australia
Secondary sponsor category [1] 308295 0
None
Name [1] 308295 0
Address [1] 308295 0
Country [1] 308295 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307656 0
South Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 307656 0
Ethics committee country [1] 307656 0
Australia
Date submitted for ethics approval [1] 307656 0
10/02/2021
Approval date [1] 307656 0
21/04/2021
Ethics approval number [1] 307656 0
2020/ETH02360

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

Contacts
Principal investigator
Name 108030 0
Mrs Sacha Bossina
Address 108030 0
Liverpool Hospital, Physiotherapy Deaprtment, Level 2 Health Services Building ,Goulburn and Campbell St Liverpool NSW 2170
Country 108030 0
Australia
Phone 108030 0
+61 2 87384707
Fax 108030 0
Email 108030 0
sacha.bossina@health.nsw.gov.au
Contact person for public queries
Name 108031 0
Sacha Bossina
Address 108031 0
Liverpool Hospital, Physiotherapy Department, Level 2 Health Services Building ,Goulburn and Campbell St Liverpool NSW 2170
Country 108031 0
Australia
Phone 108031 0
+61 2 87384759
Fax 108031 0
Email 108031 0
sacha.bossina@health.nsw.gov.au
Contact person for scientific queries
Name 108032 0
Sacha Bossina
Address 108032 0
Liverpool Hospital, Physiotherapy Department, Level 2 Health Services Building ,Goulburn and Campbell St Liverpool NSW 2170
Country 108032 0
Australia
Phone 108032 0
+61 2 87384759
Fax 108032 0
Email 108032 0
sacha.bossina@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
deidentified outcome measures: individual participant data published results
When will data be available (start and end dates)?
At the end of trial, once 62 participants recruited and results collated, potentially up until 2023
Available to whom?
via publication
Available for what types of analyses?
qualitative and quantitative analysis to reflect the aims of the study protocol
How or where can data be obtained?
via publication


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.