ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12612000308897

Ethics application status

Approved

Date submitted

16/03/2012

Date registered

19/03/2012

Date last updated

23/03/2016

Type of registration

Prospectively registered

Titles & IDs

Public title

Telephone Coaching for Knee Osteoarthritis

Scientific title

The effect of telephone coaching in addition to physiotherapy compared with physiotherapy alone on pain and physical function for people with knee osteoarthritis

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1129-1270

Trial acronym

TELCKO

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Knee osteoarthritis

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Health coaching via telephone to support a physiotherapist provided physical activity program. The intervention phase will last 6 months.

Health coaching: Three health coaches will provide the telephone coaching for the study. The health coaches will all have a qualification and experience in nursing and will have been trained in health coaching by Health Change Australia. Participants will be called a minimum of 6 times and a maximum of 12 times during the 6-month treatment phase. The health coach will determine how many additional telephone coaching sessions are needed based on the participant’s preferences, their confidence and their success in achieving the desired behaviour changes. The duration of telephone coaching sessions are expected to average around 20 mins with considerable variability. The initial calls are likely to be longer (up to 45 mins) with call duration reducing over the treatment phase.

Physiotherapy: Each participant will visit the physiotherapist five times, and each session will last for 30 minutes. The treatment program will include three components:
1. Structured exercises to address presenting impairments
2. Increasing overall levels of physical activity
3. Information and education

Intervention code [1]

Behaviour

Intervention code [2]

Treatment: Other

Comparator / control treatment

Physiotherapist provided physical activity program alone. The physiotherapy treatment is the same as provided for the intervention group.

Control group

Active

Outcomes

Primary outcome [1]

Pain assessed by 11-point numeric rating scale

Timepoint [1]

Baseline and 6, 12 and 18 months

Primary outcome [2]

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

Timepoint [2]

Baseline and 6, 12 and 18 months

Secondary outcome [1]

Physical activity assessed by self report measures (Physical activity scale for the elderly, PASE, and the Active Australia Survey)

Timepoint [1]

Baseline and 6, 12 and 18 months

Secondary outcome [2]

Physical activity assessed objectively using the activPAL (TM) activity monitor (Pal Technologies, Glasgow, UK)

Timepoint [2]

Baseline and 6 months

Secondary outcome [3]

Global rating of change. Participant perceived response to treatment - Participants will rate their perceived change in pain, in physical function and in change overall with treatment (compared to baseline) on a 7-point ordinal scale

Timepoint [3]

Baseline and 6, 12 and 18 months

Secondary outcome [4]

Health related quality of life assessed using the Quality of Life instrument version 2 (AQoLII)

Timepoint [4]

Baseline and 6, 12 and 18 months

Secondary outcome [5]

Psychological variables that are potential moderators and/or mediators of physical activity behaviour, pain and function among people with knee OA:
The Arthritis Self Efficacy Scale
Self-Efficacy for Physical Activity Scale
Benefits of Physical Activity Scale
Barriers to Physical Activity Scale
Self-Regulation scale
Arthritis Impact Measurement Scale (AIMS2) (Psychological subscale)
Depression, Anxiety and Stress (DASS) scale
Patient Health Questionnaire-9 (PHQ-9)
Coping Strategies Questionnaire (CSQ)
Pain Catastrophising Scale

Timepoint [5]

Baseline and 6, 12 and 18 months

Secondary outcome [6]

Health service usage: Prospective self-reported direct health care use will be collected every 3 months using log sheets.

Timepoint [6]

Recorded at 3, 6, 9, 12, 15 and 18 months

Eligibility

Key inclusion criteria

Knee pain on most days and present for at least 3 months.
Average pain at least 4/10 on 11-point numeric rating scale (ranging from 0='no pain' to 10='worst pain possible').
Meeting American College of Rheumatology criteria for clinical diagnosis of osteoarthritis (assessed by physiotherapist)
Currently inactive or insufficiently active according to Active Australia Survey.

Minimum age

50 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Ipsilateral knee replacement or high tibial osteotomy.
Knee surgery including arthroscopy in past 6 months.
Knee malignancy.
Fracture or major trauma that impacted the knee joint in previous 6 months.
Oral or injected corticosteroids or other knee injection in previous 3 months.
Plans to have knee surgery or injections in next 18 months.
Physiotherapy or other physical treatments specifically for knee pain in previous 3 months or for two or more consecutive weeks in previous 6 months.
Plans to have physical treatment specifically for knee in next 6 months.
Participated in lower limb muscle strengthening exercise for more than once per week in previous 6 months.
Inflammatory arthritic condition including rheumatoid arthritis and fibromyalgia.
Neurological condition affecting lower limb movement including stroke, multiple sclerosis, neuropathy or Parkinson's disease.
Other health problems that precludes them from doing physical activity.

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 they will be allocated. Allocation will be concealed in opaque envelopes.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Permuted block randomisation stratified by physiotherapist. The physiotherapist will be determined according to geographical location.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/06/2012

Actual

30/06/2012

Date of last participant enrolment

Anticipated

Actual

13/08/2013

Date of last data collection

Anticipated

Actual

Sample size

Target

168

Accrual to date

Final

168

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment postcode(s) [1]

3004

Recruitment postcode(s) [2]

3002

Recruitment postcode(s) [3]

3003

Recruitment postcode(s) [4]

3051

Recruitment postcode(s) [5]

3205

Recruitment postcode(s) [6]

3844

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

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

Country [1]

Australia

Primary sponsor type

University

Name

The University of Melbourne

Address

The University of Melbourne
Victoria 3010
Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Melbourne Human Research Ethics Committee

Ethics committee address [1]

Melbourne Research
The University of Melbourne
Level 5, Alan Gilbert Building
VIC 3010

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/05/2012

Ethics approval number [1]

1137237

Summary

Brief summary

Knee osteoarthritis (OA) is one of the most common and costly chronic musculoskeletal conditions world-wide and is associated with substantial pain and disability. Many patients also experience co-morbidities such as obesity and cardiovascular disease that further add to the OA burden.  
	Interventions that foster appropriate lifestyle behavioural change, particularly in the area of physical activity, are important for chronic diseases such as OA. Physical activity, encompassing both structured exercise and incidental physical activity, is recommended by OA and general health guidelines because of its positive impact on disease outcomes and health status. Both muscle strengthening and aerobic exercise are effective in reducing pain and improving function in the short-term in patients with knee OA. However, benefits are generally not sustained because adherence declines over time. Interventions are therefore needed to facilitate sustainability of physical activity behaviours in patients with knee OA in order to achieve longer-term clinical improvements and to reduce the risk and impact of associated co-morbidities. 
	Evidence-based strategies to improve uptake and adherence to physical activity and/or exercise interventions for people with chronic musculoskeletal conditions include incorporating face-to-face visits with a health professional, support from telephone coaching, refresher or booster sessions, exercise and physical activity plans based on patient preference and individual goals, an educational component, and optional strategies including log-book recording of participation and step counting. Telephone coaching is a relatively inexpensive intervention using widely available technology. It has been shown to improve physical activity behaviours in older adults and in those with other chronic conditions, particularly if combined with face-to-face visits with a health professional. Thus telephone coaching aimed at changing physical activity behaviours may achieve longer-term improved patient outcomes in those with knee OA but there is limited research in this area.
This pragmatic trial will investigate the clinical- and cost-effectiveness of a 6-month physical activity intervention on pain and function in people with knee OA. The intervention package incorporates 5 physiotherapy contacts together with 6-12 telephone coaching contacts. The intervention will be compared to a physiotherapy only condition.

Trial website

Trial related presentations / publications

1. Bennell KL, Egerton T, Bills C, et al. Addition of telephone coaching to a physiotherapist-delivered physical activity program in people with knee osteoarthritis: a randomised controlled trial protocol. BMC musculoskeletal disorders 2012;13:246 doi: 10.1186/1471-2474-13-246.

Public notes

Contacts

Principal investigator

Name

Prof Kim Bennell

Address

Centre for Health, Exercise and Sports Medicine
Level 7
Alan Gilbert Building
Building 104
The University of Melbourne
Vic, 3010

Country

Australia

Phone

+6138344 4171

Fax

physio-enquiries@unimelb.edu.au

Contact person for public queries

Name

Penny Campbell

Address

Centre for Health, Exercise and Sports Medicine
Level 7
Alan Gilbert Building
Building 104
The University of Melbourne
Vic, 3010

Country

Australia

Phone

+6138344 4171

Fax

penelope.campbell@unimelb.edu.au

Contact person for scientific queries

Name

Professor Kim Bennell

Address

Centre for Health, Exercise and Sports Medicine
Level 7
Alan Gilbert Building
Building 104
The University of Melbourne
Vic, 3010

Country

Australia

Phone

+ 61 3 83444135

Fax

k.bennell@unimelb.edu.au

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	The association between psychological characteristics and physical activity levels in people with knee osteoarthritis: A cross-sectional analysis.	2020	https://dx.doi.org/10.1186/s12891-020-03305-2
Embase	A comparison of psychological characteristics in people with knee osteoarthritis from Japan and Australia: A cross-sectional study.	2022	https://dx.doi.org/10.1371/journal.pone.0267877

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

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Documents added manually

Documents added automatically