Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000536561
Ethics application status
Approved
Date submitted
12/02/2024
Date registered
30/04/2024
Date last updated
2/10/2024
Date data sharing statement initially provided
30/04/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Telehealth delivered motivational interviewing and cognitive behaviour therapy to support exercise-based rehabilitation for people with lower limb osteoarthritis: a pilot randomized control trial
Scientific title
Telehealth delivered motivational interviewing and cognitive behaviour therapy to support exercise-based rehabilitation for people with lower limb osteoarthritis: a pilot randomized control trial
Secondary ID [1] 311520 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 332868 0
Knee pain 332869 0
Hip pain 333106 0
Condition category
Condition code
Musculoskeletal 329587 329587 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive a written explanation of the walking program. The program comprises walking for at least 30 minutes, at a minimum frequency of 3 times a week, for six weeks (Kolasinski et al., 2020; Loew et al., 2012; Van den Ende et al., 1998). Participants will be instructed to walk at a heart rate intensity of 55 to 70% of the maximum heart rate (MHR), as recommended by several authors (Brosseau et al., 1996; Loew et al., 2012). Therefore, MHR will be calculated based on the revised MHR equation (211 – 0.64 x age) to determine the target range of 55 to 70% MHR (Nes et al., 2013; Williams, 2017). Because we will not offer a heart rate monitor, participants will be trained to use a Borg Scale Exertion Scale as a reference to determine heart rate intensity of 55 to 70% MHR while walking (Borg, 1998; Norton et al., 2010). The intensity category 'moderate’ is equivalent to 55 to 70% MHR (Norton & Norton, 2011). Only at the baseline assessment, during the 6 minute walk test, participants will use a heart rate monitor and the Borg Rating of Perceived Exertion Scale to learn how to correlate the target intensity. A Borg Rating of Perceived Exertion Scale will be printed on a laminated card and given to participants to help them track their walking intensity during the intervention. Therefore, participants will be instructed to carry the Borg Rating of Perceived Exertion Scale card during their walking sessions as a reference reminder. During the six-week program, participants will be contacted over the phone once per week to collect information on adherence to the walking program (duration spent walking per session, distance covered and number of steps) and to deliver the social support intervention. In the MI-CBT group, MI-CBT techniques will be used by a trained therapist to provide individualised support, identify helpful and unhelpful beliefs regarding their ability to complete exercise program, and to increase engagement. In the Education only group, participants will be provided with advice regarding exercise maintenance in a directive way, without providing any specific MI-CBT based support.

We foresee it taking about 5 minutes to collect information on adherence and up to 25 minutes to deliver either MI-CBT or Education only. The MI-CBT intervention will be delivered in two phases. In the first phase (three weeks), the researcher will deliver 3 sessions using MI only. The main objective of the first phase is to create a trustworthy relationship through the five MI general principles (empathy, develop discrepancy, avoiding argument, rolling with resistance and self-efficacy) (Miller & Rollnick, 2012). These principles will be delivered through open-ended questions, affirmations, reflections and summaries, encouraging the participant’s sense of the possibility of change (Miller & Rollnick, 2012). The second phase of MI-CBT intervention (three weeks) is designed to maintain behaviour change (Naar-King et al., 2013). The CBT component is focused on six theoretical determinants: outcome expectations, outcome experiences, values, barriers to self-efficacy, social support, and lapse prevention (Barrett et al., 2020; Michie et al., 2011).
Intervention code [1] 327973 0
Behaviour
Intervention code [2] 327974 0
Rehabilitation
Comparator / control treatment
Control group participants will receive an active control:
One weekly phone call from the researcher will be used to collect data regarding the self-questionnaire (adherence) and offer social support intervention, with advice regarding exercise maintenance.
Control group
Active

Outcomes
Primary outcome [1] 337365 0
The primary outcome of interest is determining the feasibility of providing MI-CBT via telehealth to support the uptake and adherence to a walking program.
Timepoint [1] 337365 0
1) Assessment process: Week 1 to 6: Researchers will weekly report the number of phone calls until they succeed in contact with the participant.
2) Treatment fidelity: Week 1 to 6: A number of calls will be recorded weekly for quality assessment.
3) Recruitment: Week 1 to 6: A report of new participants will be issued weekly.
Adherence:
Self-questionnaire - Week 1 to 6: Participants will answer the self-questionnaire for each walking program session completed. We will contact the participant via phone call once per week to collect data about the self-questionnaire.
Smart Watch (Fitbit) - Week 1 to 6: Participants will record information about the walking program, and at the end of the intervention, the data will be downloaded for analysis.
Secondary outcome [1] 431592 0
Difference between groups in change for barriers and facilitators after intervention (measured by the barriers and facilitators to exercise survey).
We want to clarify that barriers and facilitators will be collected as a composite outcome.
Timepoint [1] 431592 0
Barriers and facilitators to exercise (Survey) - Baseline and week 6: Participants will answer a survey regarding barriers and facilitators to exercise at baseline and post-intervention, week 6.

Eligibility
Key inclusion criteria
We will recruit participants with (i) age 18 years or older, (ii) diagnosed with knee/hip osteoarthritis (OA), (iii) who can read English, (iv) living in the Greater Bendigo Region, and (v) willing to participate in exercise-based rehabilitation as a treatment for their knee/hip osteoarthritis (OA).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Other conditions that may affect exercise adherence. E.g. neurologic, cardio.

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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
Because we will perform a pilot study, the number of participants will not generate sufficient power to measure effects with statistical significance. However, it is expected to be sufficient to note trends in improvements that could be studied in a larger sequence study.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/05/2024
Actual
15/07/2024
Date of last participant enrolment
Anticipated
4/10/2024
Actual
Date of last data collection
Anticipated
15/11/2024
Actual
Sample size
Target
50
Accrual to date
7
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 42042 0
3550 - Bendigo
Recruitment postcode(s) [2] 42359 0
3555 - Golden Square

Funding & Sponsors
Funding source category [1] 315811 0
Charities/Societies/Foundations
Name [1] 315811 0
Holsworth Researcher Initiative
Country [1] 315811 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 317940 0
None
Name [1] 317940 0
Address [1] 317940 0
Country [1] 317940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314802 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 314802 0
Ethics committee country [1] 314802 0
Australia
Date submitted for ethics approval [1] 314802 0
29/03/2024
Approval date [1] 314802 0
14/06/2024
Ethics approval number [1] 314802 0
HEC24128

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

Contacts
Principal investigator
Name 132346 0
Mr Marcos de Noronha
Address 132346 0
La Trobe University, Edwards Rd, Flora Hill VIC 3552
Country 132346 0
Australia
Phone 132346 0
+61 3 54447005
Fax 132346 0
Email 132346 0
[email protected]
Contact person for public queries
Name 132347 0
Hugo DE AMORIM
Address 132347 0
La Trobe University, Edwards Rd, Flora Hill VIC 3552
Country 132347 0
Australia
Phone 132347 0
+61444524080
Fax 132347 0
Email 132347 0
[email protected]
Contact person for scientific queries
Name 132348 0
Hugo DE AMORIM
Address 132348 0
La Trobe University, Edwards Rd, Flora Hill VIC 3552
Country 132348 0
Australia
Phone 132348 0
+61444524080
Fax 132348 0
Email 132348 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?
Exercise adherence data (frequency and time spent exercising), common barriers and facilitators to exercise.
When will data be available (start and end dates)?
Data will be available immediately following publication. We foresee the study being submitted by the end of 2024. No end date has been determined.
Available to whom?
Public access.
Available for what types of analyses?
Feasibility analysis for intervention implementation.
How or where can data be obtained?
1) Public and unrestricted access via Scientific Journal content when published.
2) Data will be provided by the Principal Investigator (subject to approvals)([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.