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Trial registered on ANZCTR


Registration number
ACTRN12618000930280
Ethics application status
Approved
Date submitted
22/05/2018
Date registered
1/06/2018
Date last updated
10/03/2020
Date data sharing statement initially provided
29/08/2019
Date results information initially provided
10/03/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Better Knee, Better Me: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis – a randomised controlled trial.
Scientific title
Better Knee, Better Me: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis – a randomised controlled trial.
Secondary ID [1] 294838 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
knee osteoarthritis 307784 0
Condition category
Condition code
Musculoskeletal 306827 306827 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This trial has two intervention groups:

The "Exercise" intervention consists of education about osteoarthritis, advice on treatment options and decision support, structured exercise and physical activity plans, behaviour change support, and other self-management strategies including pain coping skills training activities. Participants will have 6 consultations with a physiotherapist via videoconferencing (approximately weeks 1, 3, 7, 11, 16, and 21 of the 24-week intervention), which will be approximately 45 minutes in duration (initial consultation) and 20 minutes in duration (subsequent consultations). During consultations, the physiotherapist will formulate appropriate goals and a tailored management plan involving a structured strengthening exercise program (e.g. quadriceps/hamstring/calf strengthening exercises) and physical activity plan (e.g. daily step goals) and provide verbal education and advice about practical self-management strategies. Management plans will be tailored according to exercise/knee pain history, functional ability, and personal goals. Custom-developed educational resources (e.g. information sheets) about osteoarthritis, treatment options, exercise and physical activity, and other self-management strategies will be provided to the participant in hard copy (mailed in a resource folder) and on a study website. Participants will have access to the study website from enrolment to the completion of their 12-month follow-up questionnaire. Participants will also receive exercise resistance bands, exercise/activity log sheets and a Fitbit to allow them to track and monitor their physical activity goals. Intervention fidelity will be assessed by audit of recordings of a sample of consultations throughout the intervention.

The "Exercise plus weight management" intervention aims to provide active weight management support in addition to the services as per the "Exercise" group intervention described above. It includes all of the elements described for the Exercise intervention and, in addition, includes access to 6 dietitian consultations via videoconferencing over 6 months, plus a weight management program, plus educational materials to support weight loss. The weight management program includes a weight loss phase (using a very low energy/ketogenic diet where 2 meals per day are replaced with Optifast products, with the aim being to lose >10% of body weight), a transition phase (moving to one meal replacement per day) and a weight maintenance phase (healthy eating with no meal replacements). The duration of the weight loss phase will be individual and will depend on the amount of weight needed to lose and adherence to the program. The duration of the transition phase will be approximately 2 weeks, and the weight maintenance phase is intended to be life-long. Dietitians will formulate a weight management plan with their participant during their initial consultation (approximately 45 minutes duration) and will review progress in follow-up consultations (approximately 20 minutes duration). The timing of all 6 dietitian consultations will be negotiated between the dietitian and participant, depending on individual needs and progress. Participants will initially be mailed a sample of meal replacement products (shakes, soups and bars of different flavours) so that they can determine their preference for flavour/type of product. Each of the meal replacement products are approximately 840-990 kilojoules (201-235 calories) per serving. Participants will also be mailed a resource folder containing information about the weight management program and additional resources to help support weight loss (e.g. information sheets about identifying/changing eating habits). Most weight management resources will be custom-developed specifically for the study, however some readily available resources will also be included (e.g. fact sheets from the Baker Heart and Diabetes Institute and the Australian Healthy Food Guide). These resources will also be provided on the study website, which participants will have access to from enrolment to completion of their 12-month follow-up questionnaire. Intervention fidelity will be assessed by audit of recordings of a sample of consultations throughout the intervention.
Intervention code [1] 301148 0
Lifestyle
Intervention code [2] 301179 0
Rehabilitation
Intervention code [3] 301316 0
Treatment: Other
Comparator / control treatment
The control group will receive information, advice and education about osteoarthritis and its management via a website. The control (information only) group website will include:
• Educational information, decision aids and other resources (e.g. information sheets about understanding osteoarthritis, treatment options, and managing pain)
• Information sheets about the role and importance of exercise, physical activity and weight loss for osteoarthritis
• Links to external websites for further help and support (eg. MyJointPain, PainHEALTH, MOVE-muscle, joint and bone health).
Participants will have access to the website from enrolment to completion of the 12-month follow-up questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 305822 0
Average overall knee pain.
Self-reported, using an 11-point numeric rating scale for “Average overall knee pain in the last week” where 0=“No pain” and 10=“Worst pain possible”.
Timepoint [1] 305822 0
Measured at baseline, 6 months and 12 months with the primary time point being 6 months.
Primary outcome [2] 305823 0
Physical function.
Self-reported, using the Western Ontario & McMaster University Osteoarthritis Index (WOMAC) Physical Function subscale..
Timepoint [2] 305823 0
Measured at baseline, 6 months and 12 months with the primary time point being 6 months.
Secondary outcome [1] 346675 0
Weight.
Self-reported.
Timepoint [1] 346675 0
Baseline, 6 months, 12 months
Secondary outcome [2] 346676 0
Physical activity.
Measured using the Incidental and Planned Exercise Questionnaire (IPEQ-W).
Timepoint [2] 346676 0
Baseline, 6 months, 12 months
Secondary outcome [3] 346677 0
Health-related quality of life.
Measured using the Assessment of Quality of Life Instrument (AQoL-8D).
Timepoint [3] 346677 0
Baseline, 6 months, 12 months
Secondary outcome [4] 346678 0
Global rating of change – overall improvement.
Self-reported, using a 7-point global rating of change Likert scale for “Overall change in your study knee since you began the study” from “Much worse” to “Much better”.
Timepoint [4] 346678 0
6 months and 12 months
Secondary outcome [5] 346679 0
Satisfaction with care.
Self-reported, using a 7-point Likert scale for “Overall satisfaction with the care you received in this study” from “Extremely unsatisfied” to “Extremely satisfied”.
Timepoint [5] 346679 0
6 months and 12 months
Secondary outcome [6] 346680 0
Appointment with an orthopaedic surgeon.
Self-reported. Participants will be asked to identify if they have visited with an orthopaedic surgeon or have an appointment scheduled for their knee pain in the past 6 months.
Timepoint [6] 346680 0
Baseline, 6 months, 12 months
Secondary outcome [7] 346682 0
Knee joint replacement and/or knee arthroscopy procedures since enrolment.
Self-reported.
Timepoint [7] 346682 0
6 months and 12 months
Secondary outcome [8] 346975 0
Knee joint replacement and/or knee arthroscopy procedures beyond the life of the trial. Data provided by Medibank.
Timepoint [8] 346975 0
2 years and 5 years
Secondary outcome [9] 346976 0
Data for health economic evaluation including health care usage and costs which are self-reported, using a customised data collection form and work productivity self reported using the WHO HPQ short form.
Timepoint [9] 346976 0
Baseline, 6 months and 12 months.
Secondary outcome [10] 347026 0
Willingness to undergo surgery.
Self-reported. Participants will be asked about their willingness to undergo surgery on their knee in the near future (responses ranging from "definitely not willing" to "definitely willing")
Timepoint [10] 347026 0
Baseline, 6 months and 12 months
Secondary outcome [11] 347330 0
Depression.
Measured using the Depression, Anxiety, and Stress Scale (DASS-21).
Timepoint [11] 347330 0
Baseline, 6 and 12 months
Secondary outcome [12] 347331 0
Anxiety
Measured using the Depression, Anxiety, and Stress Scale (DASS-21).
Timepoint [12] 347331 0
Baseline, 6 and 12 months
Secondary outcome [13] 347332 0
Stress.
Measured using the Depression, Anxiety, and Stress Scale (DASS-21).
Timepoint [13] 347332 0
Baseline, 6 and 12 months

Eligibility
Key inclusion criteria
Our selection criteria are consistent with a clinical diagnosis of osteoarthritis from both the National Institute for Health and Care Excellence (NICE) and the Australian Clinical Care Standard for reaching diagnosis of knee osteoarthritis). Specific inclusion criteria are:
1. Aged between 45 and 80 years
2. Reports activity-related knee joint pain
3. Reports morning knee stiffness less than or equal to 30 minutes;
4. History of knee pain on most days for 3 months or more;
5. Overall average knee pain in past week self-rated as 4 or more out of 10 on an 11-point numeric rating scale;
6. Body mass index (BMI) greater than or equal to 28 kg/m2 and < 41 kg/m2;
7. Member of Medibank Private with a level of cover that includes arthroplasty surgery;
8. Able to give informed consent and to participate fully in the interventions and assessment procedures;
9. Willing to follow advice for self-management, participate in exercise/physical activity and/or participate in the weight loss program if part of their treatment program; and
10. Have the ability to regularly weigh themselves (e.g. have access to a set of bathroom scales).
Minimum age
45 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Booked for knee surgery on either knee;
2. Have had all eligible knee joints replaced (i.e. bilateral replacements or unilateral replacement with non-operated knee pain < 4 out of 10);
3. Recent knee surgery within the past 6 months;
4. Unable to speak English or unable read English;
5. Self-reported diagnosis of rheumatoid arthritis or other inflammatory arthritis;
6. Other medical condition or upcoming medical procedures that in the opinion of the research staff and/or investigators would preclude participation;
7. Unable to use/access telephone and internet;
8. For those identified as at risk from the pre-exercise and falls screening, GP does not give clearance;
9. Used low-calorie meal replacement products (e.g. Optifast /Optislim) for weight loss in previous 6 months;
10. Currently, or during the past 6 months, undertaking regular strengthening exercise for the knee or;
11. Unable to undertake Very Low Energy/ketogenic diet for medical reasons including:
a. Self-reported diagnosis of Type 1 diabetes
b. Self-reported Type 2 diabetes requiring insulin or other medication apart from metformin
c. Self-reported warfarin use
d. Stroke or cardiac event in previous 6 months
e. Unstable heart condition
f. Fluid intake restriction.

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)
To conceal allocation, the randomisation schedule will be accessed via a password-protected, computer program by a researcher not involved in participant recruitment scheduling or assessment. 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer generated, using random permuted blocks of varying sizes by a person not involved in recruitment of participants. Allocation will be stratified by history of knee surgery (arthroscopy or contralateral arthroplasty). Randomisation will occur according to a 5:5:2 ratio (due to different pre-specified effect sizes across comparisons).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Our biostatistician will analyse blinded data, with p values less than 0.05 considered significant. Comparative analyses between groups will use intention-to-treat. Multiple imputation will be used to account for missing data if warranted by the proportion of missing data. Three comparisons are of interest:
1) Exercise vs Exercise plus weight management
2) Exercise vs Control
3) Exercise plus weight management vs Control
For continuous outcomes, the mean differences in change between these groups and 95% confidence intervals (baseline minus follow-up) will be estimated using linear regression models fit to data from both follow-up time points, with random effects for participants, and accounting for clustering by physiotherapist and dietitian in the Exercise and Exercise plus Weight Management arms. Models will be adjusted for the stratification variable (history of knee surgery) and values of the outcome at baseline. Terms for time and treatment will be included, with an interaction between the two. Regression assumptions will be assessed using standard diagnostic plots. For binary outcomes, logistic regression models will be fit using generalized estimating equations to account for clustering, with risk differences and 95% confidence intervals calculated. For ordinal outcomes, proportional odds models will be fit similarly. Multinomial models will be applied if the assumption of proportional odds is not valid.

A health economic analysis will be conducted from the health care system perspective. We will assess the cost-effectiveness of the interventions analysing a range of outcomes including: i) cost per extra person with a clinically significant improvement in pain (measured as 1.8 point reduction on the pain score) and function (6 unadjusted WOMAC units) and ii) per quality-adjusted life years (QALYs) gained for the intervention compared to control at 12 months. QALYs will be calculated based on utility scores using the AQoL-8D at baseline and 12 months. The difference in health care usage between baseline and 12 months will be compared for intervention and control groups. The association between utility gains on the AQoL-8D will also be compared between the intervention and control groups. We will also determine return on investment from the perspective of Medibank where short term outcomes will be extrapolated to knee joint replacements and knee arthroscopy.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 299434 0
Commercial sector/Industry
Name [1] 299434 0
Medibank Private
Address [1] 299434 0
720 Bourke Street
Docklands
VIC 3008
Country [1] 299434 0
Australia
Funding source category [2] 299486 0
Government body
Name [2] 299486 0
National Health and Medical Research Council
Address [2] 299486 0
16 Marcus Clarke St
Canberra ACT 2601
Country [2] 299486 0
Australia
Funding source category [3] 299487 0
Charities/Societies/Foundations
Name [3] 299487 0
Medibank Better Health Foundation
Address [3] 299487 0
720 Bourke Street
Docklands
VIC 3008
Country [3] 299487 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
161 Barry Street
University of Melbourne
VIC 3010
Country
Australia
Secondary sponsor category [1] 298724 0
None
Name [1] 298724 0
Address [1] 298724 0
Country [1] 298724 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300333 0
Psychology Health and Applied Sciences Human Ethics Sub-Committee
Ethics committee address [1] 300333 0
University of Melbourne
VIC 3010
Ethics committee country [1] 300333 0
Australia
Date submitted for ethics approval [1] 300333 0
20/02/2018
Approval date [1] 300333 0
04/05/2018
Ethics approval number [1] 300333 0
1750443.1

Summary
Brief summary
This study aims to compare the effectiveness of two scalable interventions (Exercise; Exercise plus Weight Management) to each other, and to an information-only control group, for overweight/obese people with clinically diagnosed knee osteoarthritis (OA) on the primary outcomes of knee pain and function at 6 months.

The Exercise group will receive six consultations with a physiotherapist via videoconferencing over six months, including prescription of an exercise and physical activity plan, education and advice about common management strategies, and provision of educational material. The Exercise plus Weight Management group will receive six physiotherapist consultations in addition to six consultations with a dietitian via videoconferencing over six months, which will include a weight management program.

We will recruit 415 Medibank Private members from around Australia who have clinical knee OA and are overweight/obese. The primary outcomes are self-reported pain and function. A range of secondary outcomes will also be assessed including weight, physical activity, health-related quality of life, global rating of change, mood, satisfaction with care, appointments with orthopaedic surgeons, knee surgery procedures and willingness to undergo surgery. Outcomes will be measured at baseline, 6 months and 12 months. A health economic analysis will be conducted alongside the trial.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83326 0
Prof Kim Bennell
Address 83326 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Building 104
161 Barry Street
University of Melbourne VIC 3010
Country 83326 0
Australia
Phone 83326 0
+61 3 8344 4135
Fax 83326 0
Email 83326 0
k.bennell@unimelb.edu.au
Contact person for public queries
Name 83327 0
Dr Belinda Lawford
Address 83327 0
Centre for Health, Exercise and Sports Medicine
Department of Physiotherapy
School of Health Sciences
Level 7, Building 104
161 Barry Street
University of Melbourne VIC 3010
Country 83327 0
Australia
Phone 83327 0
+61 3 8344 2045
Fax 83327 0
Email 83327 0
belinda.lawford@unimelb.edu.au
Contact person for scientific queries
Name 83328 0
Prof Kim Bennell
Address 83328 0
Level 7, 161 Barry Street
University of Melbourne
VIC 3010
Country 83328 0
Australia
Phone 83328 0
+61 3 8344 4135
Fax 83328 0
Email 83328 0
k.bennell@unimelb.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
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary