Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000724875
Ethics application status
Approved
Date submitted
30/04/2021
Date registered
9/06/2021
Date last updated
10/05/2024
Date data sharing statement initially provided
9/06/2021
Date results information initially provided
10/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Mobile app for Knee Osteoarthritis: the MappKO randomised controlled trial
Scientific title
Evaluating the effects on exercise adherence and physical function of a Mobile app for Knee Osteoarthritis: the MappKO randomised controlled trial
Secondary ID [1] 303167 0
Nil known
Universal Trial Number (UTN)
Trial acronym
MappKO
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee osteoarthritis 320290 0
Condition category
Condition code
Physical Medicine / Rehabilitation 318215 318215 0 0
Physiotherapy
Musculoskeletal 319833 319833 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All participants (both intervention and control groups) will undergo two one-on-one video (Zoom) consultations with a physiotherapist over 2 weeks, both of which will be 30 minutes duration. The consultations will involve the prescription of a home-based strengthening exercise program. Participants will be provided an information booklet about how to prepare for consultations and a booklet of strength exercises, as well as 4 coloured therabands (red, green, blue, and black) for performing strengthening exercises at home.

Physiotherapists will prescribe 5-6 strengthening exercises to be performed at home three times/week, including two quadriceps exercises, one each for hip abductors, hamstrings and calf, and any other as appropriate. The intensity for the strengthening exercises will aim for 5-7 out of ten (hard to very hard) on the modified Borg Rating of Perceived Exertion CR-10 scale for strength training. During the second physiotherapy consultation, participants will also be advised how to independently progress their exercise program, and encouraged to continue with their strengthening exercises (three times per week) for the next 24 weeks.

Participants randomised to the intervention group will receive a call from a researcher who will instruct them how to download and use a free mobile exercise app. Participants will be instructed to commence using the app immediately and to use it for the following 24 weeks to assist them with their home exercise program.

Outcomes will be collected by web-based survey at baseline and 26 weeks, with the exception of the two primary outcomes, which will also be measured by web-based survey at 14 weeks. No data or analytics from the app will be used as an outcome measure.
Intervention code [1] 319485 0
Rehabilitation
Intervention code [2] 319486 0
Behaviour
Comparator / control treatment
The control group will undergo two physiotherapy consultations for a prescribed strength exercise program (as outlined above for the intervention group) but will NOT be provided with the mobile app for the 24-week period while they continue with their home exercises.

Outcomes will be collected by web-based survey at baseline and 26 weeks, with the exception of the two primary outcomes, which will also be measured by web-based survey at 14 weeks.
Control group
Active

Outcomes
Primary outcome [1] 326213 0
Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale.
Timepoint [1] 326213 0
Baseline & 26 weeks after randomisation (secondary follow-up time-point= 14 weeks after randomisation)
Primary outcome [2] 326214 0
Self-reported number of days that strengthening exercises provided by the physiotherapist were performed in the previous fortnight (reported via survey)
Timepoint [2] 326214 0
26 weeks after randomisation (secondary follow-up time-point= 14 weeks after randomisation)
Secondary outcome [1] 390539 0
Self-reported severity of knee pain during walking over the past week, scored on an 11-point numerical rating scale
Timepoint [1] 390539 0
Baseline & 26 weeks after randomisation
Secondary outcome [2] 390540 0
Knee injury and Osteoarthritis Outcome Score (KOOS) sport and recreation subscale.
Timepoint [2] 390540 0
Baseline & 26 weeks after randomisation
Secondary outcome [3] 390541 0
Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale.
Timepoint [3] 390541 0
Baseline & 26 weeks after randomisation
Secondary outcome [4] 390542 0
Physical Activity Scale for the Elderly (PASE)
Timepoint [4] 390542 0
Baseline & 26 weeks after randomisation
Secondary outcome [5] 390543 0
Self-efficacy for Exercise Scale
Timepoint [5] 390543 0
Baseline & 26 weeks after randomisation
Secondary outcome [6] 390544 0
Global rating of change in knee pain- scored using a 7-point global rating of change Likert scale with response options ranging from “much worse” to “much better” when compared to baseline.
Timepoint [6] 390544 0
26 weeks after randomisation
Secondary outcome [7] 390545 0
Global rating of change in physical function- scored using a 7-point global rating of change Likert scale with response options ranging from “much worse” to “much better” when compared to baseline.
Timepoint [7] 390545 0
26 weeks after randomisation
Secondary outcome [8] 390546 0
Global change in knee overall- scored using a 7-point global rating of change Likert scale with response options ranging from “much worse” to “much better” when compared to baseline.
Timepoint [8] 390546 0
26 weeks after randomisation
Secondary outcome [9] 390554 0
Self-reported satisfaction with the exercise program (including mobile app, if applicable)- scored on a 7-point global rating of change scale with response options from “extremely unsatisfied” to “extremely satisfied”.
Timepoint [9] 390554 0
26 weeks after randomisation
Secondary outcome [10] 390560 0
Exercise Adherence Rating Scale (EARS)- scored using the 6-item section B of the EARS.
Timepoint [10] 390560 0
26 weeks after randomisation
Secondary outcome [11] 394665 0
Willingness to undergo knee joint replacement, scored on a Likert Scale with response options of Definitely not willing; Probably not willing; Unsure; Probably willing; Definitely willing.
Timepoint [11] 394665 0
Baseline & 26 weeks after randomisation

Eligibility
Key inclusion criteria
i) meet National Institute for Health and Care Excellence clinical criteria for OA (age at least 45 years; activity-related knee joint pain; morning knee stiffness lasts no more than 30 mins);
ii) report history of knee pain for at least 3mths;
iii) report knee pain on most days of the past month;
iv) report at least mild physical dysfunction (score >20 out of 68 on Western Ontario McMaster Universities (WOMAC) physical function subscale);
v) access to a computer/laptop/tablet/smartphone with internet connection for Zoom consultations;
vi) own a smartphone with software compatible with the app (for using app if allocated to intervention group);
vii) willing to participate in video consultations for physiotherapy appointments; and
viii) willing to download and engage with an app regularly (if allocated to intervention group).
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
i) inability to speak or read English;
ii) on waiting list for/planning knee/hip surgery in next 6 months;
iii) previous arthroplasty on affected knee;
iv) recent knee surgery (past 6 months);
v) consulting/ed physiotherapy or doing regular strengthening (at least once per week) exercise for knee (past 6 mths);
vi) self-reported inflammatory arthritis (eg rheumatoid arthritis);
vii) any neurological condition affecting lower limbs;
viii) any unstable/uncontrolled cardiovascular condition;
ix) history of fall (past 12 months) and no GP clearance to participate;
x) house-bound due to immobility and no GP clearance to participate; and/or
xi) fail the Exercise and Sports Science Australia stage 1 pre-exercise screening questions (consists of seven questions which are answered YES or NO, and are designed to identify individuals with signs or symptoms of underlying disease, or who may be at higher risk of an adverse event during exercise) and no GP clearance to participate.

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)
The person who will determine if a potential participant is eligible for inclusion in the trial will be unaware, when this decision is made, to which group the participant will be allocated. The randomisation schedule will be concealed in a password protected computer database. A member of our research team will maintain and access the schedule and reveal allocation to the Trial Coordinator as each participant requires randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be prepared by the biostatistician (permuted random block sizes) stratified by physiotherapist.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Parallel
Other design features
Pragmatic superiority randomised controlled trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample Size Calculation: We aim to detect the minimal clinically important difference (MCID) on the clinical co-primary outcome of 6 units in physical function on WOMAC. Assuming a between-participant standard deviation of 12 units, a baseline to 26-week correlation of 0.5, an ANCOVA adjusted for baseline score, and an adjusted alpha of 0.025, we need 58 per arm to achieve 80% power. To detect a difference of 1.2 sessions in the adherence co-primary outcome at 26-week follow-up between groups, assuming a standard deviation of 2.4, 80% power and alpha of 0.025, 77 participants per arm are required. Allowing for 15% attrition, we will recruit 91 people/arm in total (n=182) to have sufficient power for both primaries.

Analysis Plan: A biostatistician will analyse blinded data. Main comparative analyses between groups will be performed using intention-to-treat. Multiple imputation will be used to account for missing data if necessary. Differences in mean change in function (baseline minus follow-up) will be compared between groups using a mixed-effects linear regression model including all data from 14 and 26 weeks for each participant, adjusted for baseline values and the stratifying variable of physiotherapist. A similar mixed linear regression model will be used for the co-primary outcome of adherence, except, as there is no baseline adherence, there will be no adjustment for baseline values and the outcome will be follow-up score. For continuous secondary outcomes, differences in change (baseline minus follow-up) will be compared between groups using mixed-effects linear regression models adjusted for baseline values and the stratifying variable, with random effects for physiotherapists. The proportion of participants in each group that show an improvement that reaches or exceeds the MCID in pain (at least 1.8 units ) and function (at least 6 units) will also be calculated. For these and other binary outcomes, groups will be compared using risk differences and risk ratios, calculated from logistic regression models adjusted for the stratifying variable of physiotherapist and fit using generalized estimating equations.
Standard diagnostic plots will be used to check model assumptions. Effect modification by pre-specified baseline characteristics will be assessed through the inclusion of appropriate interaction terms in the regression models for the primary outcomes

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/07/2021
Actual
17/08/2021
Date of last participant enrolment
Anticipated
30/04/2023
Actual
21/12/2023
Date of last data collection
Anticipated
20/06/2024
Actual
Sample size
Target
182
Accrual to date
Final
182
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 307574 0
University
Name [1] 307574 0
University of Melbourne Establishment Grant
Country [1] 307574 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Office of Research, Ethics and Integrity
Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
University of Melbourne VIC 3010
Country
Australia
Secondary sponsor category [1] 308261 0
None
Name [1] 308261 0
Address [1] 308261 0
Country [1] 308261 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307633 0
The University of Melbourne Science, Technology, Engineering, Mathematics and Medicine 3 Human Research Ethics Committee
Ethics committee address [1] 307633 0
Office of Research Ethics and Integrity
Research, Innovation & Commercialisation
Level 5, Alan Gilbert Building, 161 Barry Street, Carlton
The University of Melbourne, Victoria 3010 Australia
Ethics committee country [1] 307633 0
Australia
Date submitted for ethics approval [1] 307633 0
01/12/2020
Approval date [1] 307633 0
23/12/2020
Ethics approval number [1] 307633 0
2020-20727-13363-3

Summary
Brief summary
We are conducting a clinical trial to compare the outcomes of two different treatments:
i) two telehealth consultations with a physiotherapist (for prescription of home-based strengthening exercises); and
ii) two telehealth consultations with a physiotherapist (for prescription of home-based strengthening exercises) plus the subsequent use of a mobile app for 24 weeks.

Participants in both groups will receive exercise-based care by a physiotherapist. This will involve two telehealth consultations with a physiotherapist (using Zoom video-conferencing) over two weeks, for prescription of an individualised strengthening exercise program. Participants in both groups will receive resistance bands for exercising. After completing the physiotherapy consultations, participants will be encouraged to continue with their home exercises for the next 24 weeks. Around half of participants will be randomly allocated to download and engage with a mobile app (on their smartphone or tablet) as well, for the 24 week home exercise period. Outcomes will be collected by web-based survey at baseline and 26 weeks after randomisation, with the exception of the two primary outcomes, which will also be measured by web-based survey at 14 weeks after randomisation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107938 0
Prof Rana Hinman
Address 107938 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building
The University of Melbourne, Victoria 3010 Australia
Country 107938 0
Australia
Phone 107938 0
+61 3 8344 3223
Fax 107938 0
Email 107938 0
[email protected]
Contact person for public queries
Name 107939 0
Miss Sarah Stratulate
Address 107939 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building
The University of Melbourne, Victoria 3010 Australia
Country 107939 0
Australia
Phone 107939 0
+61 3 9035 5702
Fax 107939 0
Email 107939 0
[email protected]
Contact person for scientific queries
Name 107940 0
Prof Rana Hinman
Address 107940 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
Level 7, Alan Gilbert Building
The University of Melbourne, Victoria 3010 Australia
Country 107940 0
Australia
Phone 107940 0
+61 3 8344 3223
Fax 107940 0
Email 107940 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseExercise adherence Mobile app for Knee Osteoarthritis: protocol for the MappKO randomised controlled trial.2022https://dx.doi.org/10.1186/s12891-022-05816-6
N.B. These documents automatically identified may not have been verified by the study sponsor.