ANZCTR - Registration

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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]

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

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Physical Medicine / Rehabilitation

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]

Behaviour

Intervention code [2]

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]

Average knee pain over the previous week assessed by 11-point numeric rating scale

Timepoint [1]

Collected at baseline, 6 and 12 months. The primary time point is 6 months.

Primary outcome [2]

Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale

Timepoint [2]

Collected at baseline, 6 and 12 months. The primary time point is 6 months.

Secondary outcome [1]

Self-reported knee pain assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) pain sub-scale

Timepoint [1]

Baseline, 6 and 12 months

Secondary outcome [2]

Arthritis self-efficacy measured by the Arthritis Self-Efficacy Scale

Timepoint [2]

Baseline, 6 and 12 months

Secondary outcome [3]

Health-related quality of life assessed using the Assessment of Quality of Life instrument (AQoL-8D)

Timepoint [3]

Baseline, 6 and 12 months

Secondary outcome [4]

Physical activity measured by the Physical Activity Scale for the Elderly (PASE)

Timepoint [4]

Baseline, 6 and 12 months

Secondary outcome [5]

Average knee pain on walking over the previous week assessed by 11-point numeric rating scale

Timepoint [5]

Baseline, 6 and 12 months

Secondary outcome [6]

Benefits of Physical Activity: via the Benefits of Physical Activity Scale

Timepoint [6]

Baseline, 6 and 12 months

Secondary outcome [7]

Barriers to Physical Activity: via the Barriers to Physical Activity Scale

Timepoint [7]

Baseline, 6 and 12 months

Secondary outcome [8]

Fear of movement: assessed using the Brief Fear of Movement Scale

Timepoint [8]

Baseline, 6 and 12 months

Secondary outcome [9]

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]

Use of health services over the previous 6 months assessed at baseline, 6 and 12 months

Secondary outcome [10]

Work productivity will be calculated using the World Health Organization Health and Work Performance Questionnaire (WHO HPQ) Short form

Timepoint [10]

Baseline, 6 and 12 months

Secondary outcome [11]

Global change in knee pain (since baseline) overall using a 7-point Likert scale

Timepoint [11]

6 and 12 months

Secondary outcome [12]

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]

6 and 12 months

Secondary outcome [13]

Community exercise service/facility use- recorded via a customised questionnaire designed specifically for this study.

Timepoint [13]

6 and 12 months

Secondary outcome [14]

Satisfaction with treatment: measured using a 7-point Likert scale.

Timepoint [14]

6 months and 12 months

Secondary outcome [15]

Global change in physical function (since baseline) using a 7-point Likert scale

Timepoint [15]

6 and 12 months

Secondary outcome [16]

Global change in physical activity (since baseline) using a 7-point Likert scale

Timepoint [16]

6 and 12 months

Secondary outcome [17]

Global overall improvement in the knee (since baseline) using a 7-point Likert scale

Timepoint [17]

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?

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]

3010 - University Of Melbourne

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Medibank Health Research Fund

Address [1]

Head Office: 720 Bourke Street, Melbourne, VIC 3000

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council

Address [2]

National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601

Country [2]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

The University of Melbourne
VIC 3010

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Other collaborator category [1]

Commercial sector/Industry

Name [1]

Australian Physiotherapy Association

Address [1]

PO Box 437
Hawthorn BC VIC 3122
Australia

Country [1]

Australia

Other collaborator category [2]

Commercial sector/Industry

Name [2]

HealthChange Australia

Address [2]

PO Box 6890
Kangaroo Valley, 2577
NSW

Country [2]

Australia

Other collaborator category [3]

Charities/Societies/Foundations

Name [3]

Arthritis & Osteoporosis Victoria

Address [3]

263-265 Kooyong Rd
Elsternwick 3185
Vic

Country [3]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Behavioural and Social Sciences Human Ethics Sub-Committee

Ethics committee address [1]

Human Research Ethics
Office for Research Ethics and Integrity
Level 1, 780 Elizabeth Street
(University Building No. 220)
Melbourne VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

17/08/2015

Ethics approval number [1]

1544432

Summary

Brief summary

Osteoarthritis (OA) is the leading cause of pain and disability in Australia and the knee is commonly affected. OA is the 11th highest contributor to global disability and in 2008-9 was the eighth most-managed problem by Australian GPs. Exercise is a core component of best-practice management, yet access by Australians to appropriately-qualified health care providers for exercise prescription and advice is very limited. Furthermore, uptake of exercise by people with knee OA in Australia is grossly inadequate, and long-term adherence is poor. This randomised controlled trial (RCT) will evaluate the effectiveness of telephone-delivered exercise advice and behaviour change support by physiotherapists for improving knee pain and function in people with knee OA. The service will be embedded into the Musculoskeletal Help Line  that is provided by Arthritis & Osteoporosis Victoria.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Rana Hinman

Address

Physiotherapy, Melbourne School of Health Sciences The University of Melbourne Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053

Country

Australia

Phone

+61 3 8344 3223

Fax

ranash@unimelb.edu.au

Contact person for public queries

Name

Penny Campbell

Address

Level 7, CHESM The University of Melbourne Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053

Country

Australia

Phone

+61 3 9035 5702

Fax

penelope.campbell@unimelb.edu.au

Contact person for scientific queries

Name

Rana Hinman

Address

Physiotherapy, Melbourne School of Health Sciences The University of Melbourne Alan Gilbert Building, 161 Barry St Carlton, Vic, 3053

Country

Australia

Phone

+61 3 8344 3223

Fax

ranash@unimelb.edu.au

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 (ranash@unimelb.edu.au). 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.	Type	Citation	Link	Email	Other Details	Attachment
22105	Data 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

Source	Title	Year of Publication	DOI
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.	2018	https://dx.doi.org/10.1016/j.joca.2018.02.909
Embase	I was really pleasantly surprised: Firsthand experience and shifts in physical therapist perceptions of telephone-delivered exercise therapy for knee osteoarthritis-A qualitative study.	2019	https://dx.doi.org/10.1002/acr.23618
Embase	Therapeutic Alliance Between Physical Therapists and Patients With Knee Osteoarthritis Consulting Via Telephone: A Longitudinal Study.	2020	https://dx.doi.org/10.1002/acr.23890

N.B. These documents automatically identified may not have been verified by the study sponsor.

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