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Trial registered on ANZCTR


Registration number
ACTRN12621000267853
Ethics application status
Approved
Date submitted
14/01/2021
Date registered
11/03/2021
Date last updated
11/01/2023
Date data sharing statement initially provided
11/03/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of supported motivational interviewing on physical activity for people with knee osteoarthritis who have already completed a widespread exercise-therapy program (GLA:D®). A pilot study.
Scientific title
Investigating the feasibility and efficacy of SUpported Motivational InTerviewing (SUMIT) on physical activity for people with knee osteoarthritis. A pilot, feasibility randomised controlled trial.
Secondary ID [1] 303097 0
Cabrini Research Foundation: ST-093.
Universal Trial Number (UTN)
Trial acronym
SUMIT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 320186 0
Condition category
Condition code
Musculoskeletal 318129 318129 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 318130 318130 0 0
Physiotherapy
Public Health 318131 318131 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants allocated to the SUMIT group will receive five physiotherapist led motivational interviewing sessions (30-40-minutes) over 12 weeks to facilitate behaviour change towards increasing physical activity. Each session will be provided via Zoom or phone call depending on patient preference. Participants can undertake the intervention at home or any place with internet access. Participants will be required to book in a time slot with the intervention physiotherapist (CI-Bell) in weeks 1,2,4,7,10. The content of each session will refer to the recommended processes of Engagement, Focusing, Evoking and Planning. Participants will have individualised sessions, tailored to their needs at the time of each session. Topics that may arise in MI sessions may include (but are not limited to): personal barriers and enablers to physical activity, and strategies to navigate these; reflections about personal change; and managing pain. Additional education and behaviour change support related to increasing physical activity will be provided via access to a custom designed multimedia website (education resources and goal setting tools) which contains multimedia resources to promote physical activity. The website was created specifically for the SUMIT trial with feedback from physiotherapists, a psychologist and consumers. The website can only be accessed if you have the link to maintain true control subjects during the trial. Use of this website will be at the participant's discretion, however website traffic can be measured. Participants will be referred to the website during MI sessions and asked if they have used the website.
Participants will not be given a formal exercise plan, but rather be encouraged to reflect about which activities would motivate them to be more active and how those activities will fit into their lifestyle. If asked, the treating physiotherapist (CI-Bell) can give advice to tune existing programs or where to seek advice as she is a registered physiotherapist.
Attendance to MI sessions will be recorded and used to measure feasibility of a fully scale randomised controlled trial.
Participants will be supplied with an accelerometer (ActivPAL) one week before baseline and follow up assessments.
Intervention code [1] 319396 0
Treatment: Other
Intervention code [2] 319397 0
Lifestyle
Intervention code [3] 319398 0
Behaviour
Comparator / control treatment
Participants allocated to the control group will not receive any study intervention – i.e. usual care following GLA:D®, which involves continued use of exercises and self-management strategies learnt during GLA:D®. This population will attend baseline and 3-month follow up assessments. Participants in the control group will be given access to the SUMIT TREK website which contains multimedia resources to promote physical activity following 3-month follow-up.
Control group
Active

Outcomes
Primary outcome [1] 326111 0
The primary outcome is to determine the feasibility of conducting a fully powered trial to evaluate the clinical effectiveness (i.e. increasing physical activity) of using SUpported Motivational InTerviewing (SUMIT) target physical activity following completion of a widespread exercise-therapy program (GLA:D®) in people with knee osteoarthritis. Feasibility will be measured by a composite of:
i) eligibility and recruitment rates will be determined by an audit of the study database, specifically observing (1: Number of eligible volunteers: Minimum 2-3 participants per site, per month. Totalling 6-9 participants being eligible per month; 2: Recruitment rate: Minimum 2 participant per site, per month. Totalling 6 participants recruited per month);
ii) drop out rate measured by number of participants who withdraw from the study post enrolment.
iii) adherence to motivational interviewing sessions (Minimum attendance of 4/5 sessions (80%));
iv) adherence to wearing of ActivePAL device measured by time worn per participant being >16 hours per day for seven days (to account for waking hours);
v) credibility of the intervention using the Borkovec and Nau questionnaire.
Timepoint [1] 326111 0
3 months post enrolment.
Secondary outcome [1] 390172 0
Objective physical activity: ActivPAL, a device worn on the thigh to track body position, will measure step count. One-week of data will be extracted from the ActivPal device by an assessor blinded to group allocation at baseline and 3-month follow-up (JW). The ActivPAL (PAL Technologies, Glascow, Scotland) is a reliable (ICC=0.99 for step number, ICC=0.99 for cadence) measure of physical activity. ActivPAL was selected as it provides no feedback to participants and thus acts as a measuring device with no intervention.
Timepoint [1] 390172 0
3 months post enrolment.
Secondary outcome [2] 390533 0
Self-reported physical activity: The University of California, Los Angeles (UCLA) physical activity scale will classify activity level from one to ten, and is recommended for observing physical activity levels of osteoarthritis populations, with positive rating for construct validity and reliability. To collect data on types of exercise participants undertake, we will use the International Physical Activity Questionnaire- long version (IPAQ-long). The IPAQ-long covers five domains i) job-related activity; ii) transportation; iii) housework; iv) recreation, sport, and leisure time; v) time spent sitting; and has excellent test-retest reliability overall (ICC=0.81) and for physical activity (ICC=0.84-1.00).
Timepoint [2] 390533 0
3 months post enrolment.
Secondary outcome [3] 390534 0
Knee-related pain and quality of life (QoL): The Knee Osteoarthritis Outcome Score QoL subscale (KOOS-QoL) will be used to measure knee-related QoL. KOOS QoL is reliable (ICC=0.87: 95% confidence interval (CI): 0.83-0.9)7, with a low SEM of 6.6 points out of 100, is valid, responsive and with a clinically relevant (MCID) change of 10 points.
Timepoint [3] 390534 0
3 months post enrolment.
Secondary outcome [4] 390535 0
Health-related QoL: The EQ-5D-5L will measure participants health-related five domains i) mobility; ii) self-care; iii) usual activities; iv) pain/discomfort; and v) anxiety/depression, on a 5 point likert scale. The EQ-5D-5L is reliable, valid and responsive in osteoarthritis populations.
Timepoint [4] 390535 0
3 months post enrolment.
Secondary outcome [5] 390536 0
Physical fitness: The six-minute walk test (6MWT) will measure of physical fitness, and be facilitated by a blinded physiotherapist. Within knee osteoarthritis, 6MWT has excellent test-retest reliability (ICC 0.991, 95% CI 0.986-0.994).
Timepoint [5] 390536 0
3 months post enrolment.
Secondary outcome [6] 390537 0
Functional performance: Consistent with GLA:D® outcome measures and recommendations from the Osteoarthritis Research Society International recommendations, the 30 second chair test will be measured . The 30 second chair test have excellent test-retest reliability, ICC 0.91 (0.81, 0.97).
Timepoint [6] 390537 0
3 months post enrolment.
Secondary outcome [7] 390538 0
Physical health: Blood pressure will be recorded as a measure of general physical health. Blood pressure will be assessed using a sphygmomanometer. Three readings will be taken, the mean score between the second and third readings will be the participant's recorded blood pressure.
Timepoint [7] 390538 0
3 months post enrolment.
Secondary outcome [8] 391557 0
Functional performance: Consistent with GLA:D® outcome measures and recommendations from the Osteoarthritis Research Society International recommendations, the 40 metre fast paced walk test will be measured . 40m fast paced walk test has excellent test-retest reliability, ICC 0.97-0.98 (0.94, 0.99).
Timepoint [8] 391557 0
3 months post enrolment.
Secondary outcome [9] 391560 0
Physical health: Waist circumference will be recorded as a measure of general physical health. Waist circumference will be measured using a tape measure at the point between iliac crest and lowest rib.
Timepoint [9] 391560 0
3 months post enrolment.
Secondary outcome [10] 391563 0
Objective physical activity: ActivPAL, a device worn on the thigh to track body position, will measure active bouts vs. sedentary time. One-week of data will be extracted from the ActivPal device by an assessor blinded to group allocation at baseline and 3-month follow-up (JW). The ActivPAL (PAL Technologies, Glascow, Scotland) is a reliable (ICC=0.99 for step number, ICC=0.99 for cadence) measure of physical activity. ActivPAL was selected as it provides no feedback to participants and thus acts as a measuring device with no intervention.
Timepoint [10] 391563 0
3 months post enrolment.

Eligibility
Key inclusion criteria
• Diagnosis of knee osteoarthritis for participation in GLA:D® is performed by a trained physiotherapist and guided by the NICE guidelines, that is:
i) Aged > 45 years
ii) Activity-related knee pain
iii) Morning stiffness of the knee which lasts less than 30 minutes or no knee stiffness
• Have completed GLA:D® in the past 24 months at time of recruitment
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Comorbidity that would prevent participants from increasing physical activity levels as assessed by the Exercise and Sports Science Australia (ESSA) adult pre-screening tool e.g. unstable angina. Participants who do not pass the pre-screening tool will require approval from their general practitioner to participate in this trial (Nb: participants will have passed this screening to participate in GLA:D® in the previous 24-months).
• Non-English speaking (would not be able to complete questionnaires or participate in motivational interviewing sessions).
• People who have undergone lower limb surgery or back surgery over the past 12 months will be excluded from this trial.

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)
Group allocations will be concealed by a team member who is not involved in outcome assessment. At the point of group allocation, the coordinating physiotherapist (EB) will call the allocation team member to request which group the participant was allocated to. Due to the nature of the study, the outcome assessor is the only personnel able to be blinded to participant allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An external person will generate the block (4-6) randomisation sequence using https://www.sealedenvelope.com/ using a 1:1 ratio.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative: primary feasibility outcomes will be reported descriptively. Estimates of i) standard deviation of the secondary clinical outcomes; and ii) between-group differences with 95% confidence intervals in secondary clinical outcomes, will be calculated. All participants who complete baseline and follow-up will be included in analysis, following CONSORT guidelines.

Qualitative: interviews will be transcribed verbatim by a third-party transcription service, ‘Transcription Australia’. Qualitative analysis of the interview data will commence with a close review of each transcript by one researcher (research assistant) to gain an overall picture of the data. Data categories will be developed using inductive thematic analysis.4 This will be supported by NVivo software (QSR International Ptd Ltd, Melbourne, Australia) with one researcher will conduct the initial analysis (EB) with support from a senior researcher (CB). A random sample of 50% of interviews will be coded independently by a second researcher (PO) to substantiate the initial analysis. Themes will be discussed between researchers (EB, PO, CB) until a consensus is reached.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
COVID-19 impacted recruitment by reducing the available recruitment pool and delaying testing. We had to stick to a timeline and therefore did not recruit the anticipated sample.
Date of first participant enrolment
Anticipated
15/03/2021
Actual
16/03/2021
Date of last participant enrolment
Anticipated
4/03/2022
Actual
28/04/2022
Date of last data collection
Anticipated
10/06/2022
Actual
21/07/2022
Sample size
Target
42
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18386 0
Cabrini Hospital - Malvern - Malvern
Recruitment postcode(s) [1] 32473 0
3144 - Malvern
Recruitment postcode(s) [2] 32474 0
3123 - Hawthorn East
Recruitment postcode(s) [3] 32475 0
3122 - Hawthorn
Recruitment postcode(s) [4] 32476 0
3109 - Doncaster East
Recruitment postcode(s) [5] 36478 0
3350 - Ballarat
Recruitment postcode(s) [6] 36479 0
3228 - Torquay

Funding & Sponsors
Funding source category [1] 307502 0
Charities/Societies/Foundations
Name [1] 307502 0
Cabrini Research Foundation
Country [1] 307502 0
Australia
Funding source category [2] 307586 0
Charities/Societies/Foundations
Name [2] 307586 0
Arthritis Australia
Country [2] 307586 0
Australia
Primary sponsor type
Individual
Name
Miss Emily Bell
Address
LASEM (level 5 HS3), La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086.
Country
Australia
Secondary sponsor category [1] 308181 0
Individual
Name [1] 308181 0
Dr Christian Barton
Address [1] 308181 0
LASEM (level 5 HS3), La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086.
Country [1] 308181 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307574 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 307574 0
Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086.
Ethics committee country [1] 307574 0
Australia
Date submitted for ethics approval [1] 307574 0
22/12/2020
Approval date [1] 307574 0
02/02/2021
Ethics approval number [1] 307574 0
HEC20506

Summary
Brief summary
This pilot, feasibility randomised controlled trial (RCT) will recruit 42 people with knee osteoarthritis who have completed the GLA:D® Australia program. Consenting participants will be randomised to an additional intervention to promote physical activity (motivational interviewing and web-based support), or usual care (continuation of exercises and self-management learnt in GLA:D®).

Objectives:
The primary objective is to determine the feasibility (eligibility and recruitment rates; adherence to motivational interviewing sessions, drop-out rate, credibility of the intervention) of conducting a fully powered trial to evaluate the clinical effectiveness (i.e. increasing physical activity) of using SUpported Motivational InTerviewing (SUMIT) targeting physical activity following completion of a widespread exercise-therapy program (GLA:D®) in people with knee osteoarthritis.

Secondary objectives include:
• To determine if a worthwhile treatment effect could be observed for physical activity, physical endurance, joint-related quality of life (QoL), health-related QoL and pain.
• To refine SUMIT through qualitative feedback from participants.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107726 0
Miss Emily Bell
Address 107726 0
HS3 403, LASEM, La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086.
Country 107726 0
Australia
Phone 107726 0
+61 03 9479 5480
Fax 107726 0
Email 107726 0
[email protected]
Contact person for public queries
Name 107727 0
Emily Bell
Address 107727 0
HS3 403, LASEM, La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086.
Country 107727 0
Australia
Phone 107727 0
+61 03 9479 5480
Fax 107727 0
Email 107727 0
[email protected]
Contact person for scientific queries
Name 107728 0
Emily Bell
Address 107728 0
HS3 403, LASEM, La Trobe University, Plenty Rd &, Kingsbury Dr, Bundoora VIC 3086.
Country 107728 0
Australia
Phone 107728 0
+61 03 9479 5480
Fax 107728 0
Email 107728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual patient data would be available upon reasonable request provided the participant consented to future research use and University legal approval.
When will data be available (start and end dates)?
Data will be available from the conclusion of the trial until 7 years following the conclusion of the data, at which point it may be destroyed.
Available to whom?
Reasonable requests for appropriate research projects or health projects will be considered.
Available for what types of analyses?
Data may be used for retrospective analysis (e.g.IPDs).
How or where can data be obtained?
To request data you will need to contact the primary sponsor CI Barton. CI Barton can be contacted via email at [email protected] .


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10254Study protocol    381167-(Uploaded-14-01-2021-16-11-09)-Study-related document.docx



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