Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000054415
Ethics application status
Approved
Date submitted
14/01/2016
Date registered
20/01/2016
Date last updated
5/04/2024
Date data sharing statement initially provided
8/01/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Telephone-delivered support and advice for people with symptomatic knee osteoarthritis: Telecare Study
Scientific title
Effect of telephone-delivered advice on pain and function in people with knee osteoarthritis: Telecare trial
Secondary ID [1] 287359 0
Nil
Universal Trial Number (UTN)
U1111-1173-6945
Trial acronym
TELECARE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee Osteoarthritis 296026 0
Condition category
Condition code
Musculoskeletal 296302 296302 0 0
Osteoarthritis
Physical Medicine / Rehabilitation 297515 297515 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention: In addition to the control treatment, people allocated to intervention will also receive verbal exercise counselling and support from a physiotherapist over the phone, supplemented by written information about arthritis and the importance of exercise, exercise instructions, links to video clips and/or referral to community exercise services/facilities. Resources will be provided in hard copy via the post. Access to exercise video clips and exercise instructions will be provided via the internet, using the study website. Five to ten telephone calls (45 min duration for initial call, 20 min duration per subsequent call) will be provided over 6 months. Calls will occur in weeks 2, 4, 8, 13 & 21 of the 26 week intervention period. The physiotherapist will use as few or as many of the five additional phone calls as they deem appropriate per individual participant and will schedule these at a mutually agreed upon time. Together with the participant, the physiotherapist will devise a specific strengthening program, as well as a plan to increase general physical activity levels. The content and intensity of the strengthening exercise program will be determined by the physiotherapist in discussion with the participant. In subsequent calls, the physiotherapist will monitor progress, adjust the program and goals and provide support by increasing participant knowledge and understanding, motivation, confidence and self-efficacy for exercise. Physiotherapist will be trained in, and will use best practice principles for supporting behaviour change, when delivering the intervention. Adherence to the intervention will be monitored by a) recording the number of telephone calls the participant participated in; b) asking participants to self-rate their overall adherence to both the strengthening exercises and the general physical activity plan at 6 and 12 month follow up and; c) asking participants to record their use of community exercise facilities/services.
Intervention code [1] 292698 0
Behaviour
Intervention code [2] 293635 0
Rehabilitation
Comparator / control treatment
Control: the current nurse-led Musculoskeletal Help Line service administered by Arthritis & Osteoporosis Victoria will be provided. Participants will receive verbal information, written materials and/or referral to consumer and/or organisational websites. Participants may receive one or more phone calls, or follow-up via email, according to patient needs. Information is provided from evidence-based sources internally approved by Arthritis & Osteoporosis Victoria.
Control group
Active

Outcomes
Primary outcome [1] 295956 0
Average knee pain over the previous week assessed by 11-point numeric rating scale
Timepoint [1] 295956 0
Collected at baseline, 6 and 12 months. The primary time point is 6 months.
Primary outcome [2] 295957 0
Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale
Timepoint [2] 295957 0
Collected at baseline, 6 and 12 months. The primary time point is 6 months.
Secondary outcome [1] 317022 0
Self-reported knee pain assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) pain sub-scale
Timepoint [1] 317022 0
Baseline, 6 and 12 months
Secondary outcome [2] 317023 0
Arthritis self-efficacy measured by the Arthritis Self-Efficacy Scale
Timepoint [2] 317023 0
Baseline, 6 and 12 months
Secondary outcome [3] 317024 0
Health-related quality of life assessed using the Assessment of Quality of Life instrument (AQoL-8D)
Timepoint [3] 317024 0
Baseline, 6 and 12 months
Secondary outcome [4] 317025 0
Physical activity measured by the Physical Activity Scale for the Elderly (PASE)
Timepoint [4] 317025 0
Baseline, 6 and 12 months
Secondary outcome [5] 317026 0
Average knee pain on walking over the previous week assessed by 11-point numeric rating scale
Timepoint [5] 317026 0
Baseline, 6 and 12 months
Secondary outcome [6] 317028 0
Benefits of Physical Activity: via the Benefits of Physical Activity Scale
Timepoint [6] 317028 0
Baseline, 6 and 12 months
Secondary outcome [7] 317029 0
Barriers to Physical Activity: via the Barriers to Physical Activity Scale
Timepoint [7] 317029 0
Baseline, 6 and 12 months
Secondary outcome [8] 317030 0
Fear of movement: assessed using the Brief Fear of Movement Scale
Timepoint [8] 317030 0
Baseline, 6 and 12 months
Secondary outcome [9] 317031 0
Use of health services (e.g. medications, co-interventions, visits to health care providers), prescription and over the counter medication and hospitalisation collected via questionnaire for a retrospective period of 6 months. The questionnaire has been designed specifically for this study.
Timepoint [9] 317031 0
Use of health services over the previous 6 months assessed at baseline, 6 and 12 months
Secondary outcome [10] 317032 0
Work productivity will be calculated using the World Health Organization Health and Work Performance Questionnaire (WHO HPQ) Short form
Timepoint [10] 317032 0
Baseline, 6 and 12 months
Secondary outcome [11] 317033 0
Global change in knee pain (since baseline) overall using a 7-point Likert scale
Timepoint [11] 317033 0
6 and 12 months
Secondary outcome [12] 317035 0
Adverse events over the prior 6 months: defined as any health problem the participant experienced that was caused by the advice received over the phone as part of the study (e.g. increased knee pain, back pain as a result of exercising etc) that caused the participant to seek treatment/medication and/or interfered with their function for 2 or more days. These will be recorded by a customised questionnaire designed specifially for this study.
Timepoint [12] 317035 0
6 and 12 months
Secondary outcome [13] 319633 0
Community exercise service/facility use- recorded via a customised questionnaire designed specifically for this study.
Timepoint [13] 319633 0
6 and 12 months
Secondary outcome [14] 319904 0
Satisfaction with treatment: measured using a 7-point Likert scale.
Timepoint [14] 319904 0
6 months and 12 months
Secondary outcome [15] 319971 0
Global change in physical function (since baseline) using a 7-point Likert scale
Timepoint [15] 319971 0
6 and 12 months
Secondary outcome [16] 319972 0
Global change in physical activity (since baseline) using a 7-point Likert scale
Timepoint [16] 319972 0
6 and 12 months
Secondary outcome [17] 319973 0
Global overall improvement in the knee (since baseline) using a 7-point Likert scale
Timepoint [17] 319973 0
6 and 12 months

Eligibility
Key inclusion criteria
Participants aged 45 years or over with painful knee osteoarthritis (OA) will be recruited. People will be eligible if they report average knee pain of at least 4 on 11-point numerical rating scale (NRS), have had knee pain for greater than 3 months, have activity-related joint pain and have morning stiffness <30 minutes duration.
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- on the waiting list for a knee or hip replacement, or planning any lower limb or spinal surgery in the coming 12 months
- have had a knee joint replacement in the affected knee
- undergone knee surgery in the prior 3 months
- currently undertaking exercise prescribed by a health professional in the past 6 months
- unable to speak or read English
- unable to use/access a telephone
- self-reported diagnosis of rheumatoid arthritis
- any neurological condition (such as stroke, multiple sclerosis, polio, a neuropathy, peripheral nerve disease, Parkinson’s disease) that affects ability to exercise safely
- any cardiovascular condition (such as unstable cardiac disease, uncontrolled hypertension, uncontrolled metabolic disease, abdominal aortic aneurysm)
- fail pre-exercise screening (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)
- fail additional questions regarding falls risk or 'house bound' - which have been added to identify whether or not individuals have a higher risk of falls/adverse events when carrying out home exercises.
-unable to commit to the study for 12 months.

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. Another researcher will access the randomisation schedule which will be concealed in a password protected database.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be by random permuted blocks and stratified by gender. Participants allocated to the intervention group will also be randomly allocated to one of eight trial physiotherapists.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

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
Primary endpoints are changes in pain and function at 6 months. There may be clustering effects due to people treated by the same therapist. We assume the eight therapists will treat the same number of people and an intra-cluster correlation of 0.05. We also assume a between-participant SD of 2.2 for pain and 11.6 for function, and a baseline to 6-month correlation in scores of 0.29 and 0.51 respectively. We wish to detect an effect size of 0.5. These assumptions, together with ANCOVA adjusted for baseline scores and clustering, require 70 people per arm for pain and 54 per arm for function with 80% power. Allowing for 20% attrition, we will recruit 175 people. Comparative analyses between groups will use intention-to-treat. Multiple imputation will be used to account for missing data. For continuous data, differences in mean change will be compared with linear regression random effects modelling adjusted for baseline and physiotherapist clustering. For binary and ordinal outcomes, random effects logistic and proportional odds models will be used, respectively.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/03/2016
Actual
9/03/2016
Date of last participant enrolment
Anticipated
1/12/2017
Actual
23/10/2017
Date of last data collection
Anticipated
1/12/2018
Actual
25/10/2018
Sample size
Target
175
Accrual to date
Final
175
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 10213 0
3010 - University Of Melbourne

Funding & Sponsors
Funding source category [1] 291916 0
Commercial sector/Industry
Name [1] 291916 0
Medibank Health Research Fund
Country [1] 291916 0
Australia
Funding source category [2] 291917 0
Government body
Name [2] 291917 0
National Health and Medical Research Council
Country [2] 291917 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
VIC 3010
Country
Australia
Secondary sponsor category [1] 291406 0
None
Name [1] 291406 0
None
Address [1] 291406 0
None
Country [1] 291406 0
Other collaborator category [1] 278598 0
Commercial sector/Industry
Name [1] 278598 0
Australian Physiotherapy Association
Address [1] 278598 0
PO Box 437
Hawthorn BC VIC 3122
Australia
Country [1] 278598 0
Australia
Other collaborator category [2] 278772 0
Commercial sector/Industry
Name [2] 278772 0
HealthChange Australia
Address [2] 278772 0
PO Box 6890
Kangaroo Valley, 2577
NSW
Country [2] 278772 0
Australia
Other collaborator category [3] 278773 0
Charities/Societies/Foundations
Name [3] 278773 0
Arthritis & Osteoporosis Victoria
Address [3] 278773 0
263-265 Kooyong Rd
Elsternwick 3185
Vic
Country [3] 278773 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293423 0
Behavioural and Social Sciences Human Ethics Sub-Committee
Ethics committee address [1] 293423 0
Ethics committee country [1] 293423 0
Australia
Date submitted for ethics approval [1] 293423 0
Approval date [1] 293423 0
17/08/2015
Ethics approval number [1] 293423 0
1544432

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

Contacts
Principal investigator
Name 59874 0
Prof Rana Hinman
Address 59874 0
Physiotherapy, Melbourne School of Health Sciences The University of Melbourne Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053
Country 59874 0
Australia
Phone 59874 0
+61 3 8344 3223
Fax 59874 0
Email 59874 0
[email protected]
Contact person for public queries
Name 59875 0
Penny Campbell
Address 59875 0
Level 7, CHESM The University of Melbourne Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053
Country 59875 0
Australia
Phone 59875 0
+61 3 9035 5702
Fax 59875 0
Email 59875 0
[email protected]
Contact person for scientific queries
Name 59876 0
Rana Hinman
Address 59876 0
Physiotherapy, Melbourne School of Health Sciences The University of Melbourne Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053
Country 59876 0
Australia
Phone 59876 0
+61 3 8344 3223
Fax 59876 0
Email 59876 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?
All data presented in the results paper will be made available for sharing (Hinman RS, et al. Br J Sports Med 2019;0:1–8. doi:10.1136/bjsports-2019-101183).
When will data be available (start and end dates)?
5/11/2019 - 5/11/2034 (a period of 15 years from publication)
Available to whom?
Data will be made available to researchers as required for specific, approved analyses. Data will be provided from locked, cleaned, and de- identified study database. Requests will be reviewed by the Principal Investigator prior to approval.
Available for what types of analyses?
The investigators endorse the concept of data sharing to advance medical science. All requests for data sharing will be reviewed by the Principal Investigator to ensure no conflict with any planned sub analyses and to ensure that the data are shared in an ethical and protected manner.

Analyses aimed to improve treatment of knee osteoarthritis for non-commercial purposes are eligible.
How or where can data be obtained?
By emailing the Principal Investigator ([email protected]). Data will be made available after review and approval by the Principal Investigator. Before any analysis, a signed Confidentiality Agreement and/or Data Sharing Agreement is required


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22105Data dictionary    The Data Dictionary will be supplied with the de-i... [More Details]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Embase"I was really sceptical...But it worked really well": a qualitative study of patient perceptions of telephone-delivered exercise therapy by physiotherapists for people with knee osteoarthritis.2018https://dx.doi.org/10.1016/j.joca.2018.02.909
EmbaseI was really pleasantly surprised: Firsthand experience and shifts in physical therapist perceptions of telephone-delivered exercise therapy for knee osteoarthritis-A qualitative study.2019https://dx.doi.org/10.1002/acr.23618
EmbaseTherapeutic Alliance Between Physical Therapists and Patients With Knee Osteoarthritis Consulting Via Telephone: A Longitudinal Study.2020https://dx.doi.org/10.1002/acr.23890
N.B. These documents automatically identified may not have been verified by the study sponsor.