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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] 280131 0
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 286059 0
Condition category
Condition code
Musculoskeletal 286252 286252 0 0
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] 284469 0
Behaviour
Intervention code [2] 284470 0
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] 286720 0
Pain assessed by 11-point numeric rating scale
Timepoint [1] 286720 0
Baseline and 6, 12 and 18 months
Primary outcome [2] 286721 0
Self-reported physical function assessed by Western Ontario & McMaster Osteoarthritis Index (WOMAC) physical function sub-scale
Timepoint [2] 286721 0
Baseline and 6, 12 and 18 months
Secondary outcome [1] 296532 0
Physical activity assessed by self report measures (Physical activity scale for the elderly, PASE, and the Active Australia Survey)
Timepoint [1] 296532 0
Baseline and 6, 12 and 18 months
Secondary outcome [2] 296533 0
Physical activity assessed objectively using the activPAL (TM) activity monitor (Pal Technologies, Glasgow, UK)
Timepoint [2] 296533 0
Baseline and 6 months
Secondary outcome [3] 296534 0
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] 296534 0
Baseline and 6, 12 and 18 months
Secondary outcome [4] 296535 0
Health related quality of life assessed using the Quality of Life instrument version 2 (AQoLII)
Timepoint [4] 296535 0
Baseline and 6, 12 and 18 months
Secondary outcome [5] 296536 0
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] 296536 0
Baseline and 6, 12 and 18 months
Secondary outcome [6] 296593 0
Health service usage: Prospective self-reported direct health care use will be collected every 3 months using log sheets.
Timepoint [6] 296593 0
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
Gender
Both males and females
Can healthy volunteers participate?
No
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
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)
VIC
Recruitment postcode(s) [1] 5120 0
3004
Recruitment postcode(s) [2] 5121 0
3002
Recruitment postcode(s) [3] 5122 0
3003
Recruitment postcode(s) [4] 5123 0
3051
Recruitment postcode(s) [5] 5124 0
3205
Recruitment postcode(s) [6] 5125 0
3844

Funding & Sponsors
Funding source category [1] 284905 0
Government body
Name [1] 284905 0
National Health and Medical Research Council
Address [1] 284905 0
National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 284905 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
The University of Melbourne
Victoria 3010
Australia
Country
Australia
Secondary sponsor category [1] 283781 0
None
Name [1] 283781 0
Address [1] 283781 0
Country [1] 283781 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286903 0
University of Melbourne Human Research Ethics Committee
Ethics committee address [1] 286903 0
Melbourne Research
The University of Melbourne
Level 5, Alan Gilbert Building
VIC 3010
Ethics committee country [1] 286903 0
Australia
Date submitted for ethics approval [1] 286903 0
Approval date [1] 286903 0
01/05/2012
Ethics approval number [1] 286903 0
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 33918 0
Prof Kim Bennell
Address 33918 0
Centre for Health, Exercise and Sports Medicine
Level 7
Alan Gilbert Building
Building 104
The University of Melbourne
Vic, 3010
Country 33918 0
Australia
Phone 33918 0
+6138344 4171
Fax 33918 0
Email 33918 0
physio-enquiries@unimelb.edu.au
Contact person for public queries
Name 17165 0
Ms Penny Campbell
Address 17165 0
Centre for Health, Exercise and Sports Medicine
Level 7
Alan Gilbert Building
Building 104
The University of Melbourne
Vic, 3010
Country 17165 0
Australia
Phone 17165 0
+6138344 4171
Fax 17165 0
Email 17165 0
penelope.campbell@unimelb.edu.au
Contact person for scientific queries
Name 8093 0
Prof Professor Kim Bennell
Address 8093 0
Centre for Health, Exercise and Sports Medicine
Level 7
Alan Gilbert Building
Building 104
The University of Melbourne
Vic, 3010
Country 8093 0
Australia
Phone 8093 0
+ 61 3 83444135
Fax 8093 0
Email 8093 0
k.bennell@unimelb.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary