Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000031460
Ethics application status
Approved
Date submitted
28/12/2006
Date registered
11/01/2007
Date last updated
8/12/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
A RCT of OA self-management programs comparing health professionals to lay leaders
Scientific title
To compare the effectiveness of OAK self-management program, delivered by health professionals, with the Arthritis Self-Management Program (ASMP), delivered by trained lay leaders, as determined by improvements in pain, quality of life and physical function.
Universal Trial Number (UTN)
Trial acronym
OAK (osteoarthritis of the knee self-management education program)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Osteoarthritis 1529 0
Condition category
Condition code
Musculoskeletal 1625 1625 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A two-group randomised, controlled, repeated measure study design will compare the generic Arthritis Self-Management Program (ASMP) delivered by lay leaders with the disease specific knee osteoarthritis self-management program (OAK) delivered by health professionals. Both the OAK program and the ASMP are self-management programs and are conducted over 8 weeks in a group setting. The first week and the last week include assessment sessions, and the interim 6 weeks (one 2.5hour session per week) consists of the delivery of the two different self-management programs (OAK and ASMP). All participants in both groups will continue to receive standard medical management as required. The duration of both interventions is 6 weeks. The ASMP will be the "control" group against which the OAK group is compared.
Intervention code [1] 1528 0
None
Comparator / control treatment
The generic Arthritis Self-Management Program (ASMP) delivered by lay leaders
Control group
Active

Outcomes
Primary outcome [1] 2242 0
Health status, measured using the Western Ontario and McMaster Universities (WOMAC) Osteoarthritis index
Timepoint [1] 2242 0
Measured at baseline, week 8 and 6 months
Primary outcome [2] 2243 0
Quality of life, measured using the Short Form 36 (SF36) questionnaire Version 1
Timepoint [2] 2243 0
Measured at baseline, week 8 and 6 months
Primary outcome [3] 2244 0
Level of pain, measured using a Visual Analog Scale (VAS)
Timepoint [3] 2244 0
Measured at baseline, week 8 and 6 months
Secondary outcome [1] 3912 0
Arthritis Self Efficacy Questionnaire: To determine improvement in self-efficacy
Timepoint [1] 3912 0
Measured at baseline, week 8 and 6 months
Secondary outcome [2] 3913 0
Step Test: A test of dynamic standing balance. It involves stepping one foot on, then off a block as quickly as possible in a set time period.
Timepoint [2] 3913 0
Measured at baseline, week 8 and 6 months
Secondary outcome [3] 3914 0
Timed Single Leg balance Test: This is a simple test that assesses the difficulty a person has standing on one legged. The score is the total time (in seconds) standing on one leg.
Timepoint [3] 3914 0
Measured at baseline, week 8 and 6 months

Eligibility
Key inclusion criteria
Established OA of one or both knees diagnosed either by clinical examination or by radiological (x-ray) evidence by a general practitioner (GP) or specialist physician.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those participants with rheumatoid arthritis, or other inflammatory joint disease, who plan to have knee surgery within 6 months of commencing the study, or have physical impairments that preclude them from fulfilling the requirements of the program.

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Pre-made cards (an equal number of OAK and ASMP cards) will be placed each in a sealed, opaque envelope. These will then be placed in an enclosed box. After a subject has signed informed consent, the box will be opened and an envelope containing a randomisation card will be chosen by a third party.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be allocated to study groups using simple randomisation.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Study participants will be unaware to which group they have been allocated. Assessor measuring outcome will also be blinded to group allocation. Program facilitators will be aware of group allocation. Data analyst will be unaware of group allocation.
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
29/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
146
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1772 0
University
Name [1] 1772 0
Curtin University of Technology
Country [1] 1772 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Arthritis WA
Address
PO Box 34
Wembley
Wa 6914
Country
Australia
Secondary sponsor category [1] 1577 0
Individual
Name [1] 1577 0
Dr N K Briffa
Address [1] 1577 0
Curtin University of Technology
GPO Box U1987 Perth,
Western Australia 6845
Country [1] 1577 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3316 0
Curtin University of Technology
Ethics committee address [1] 3316 0
Bentley
Ethics committee country [1] 3316 0
Australia
Date submitted for ethics approval [1] 3316 0
Approval date [1] 3316 0
Ethics approval number [1] 3316 0
HR12

Summary
Brief summary
A greater proportion of people with osteoarthritis of the knee who complete the OAK Program will report minimal clinically important improvements in pain, knee function and quality of life, at 8 and 12 weeks, compared with those completing the generic ASMP course.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27462 0
Address 27462 0
Country 27462 0
Phone 27462 0
Fax 27462 0
Email 27462 0
Contact person for public queries
Name 10717 0
Sophie Coleman
Address 10717 0
Dept of Physiotherapy
Curtin University of Technology
GPO Box U1987 Perth,
Western Australia 6845
Country 10717 0
Australia
Phone 10717 0
(08) 93876272
Fax 10717 0
(08) 93897103
Email 10717 0
[email protected]
Contact person for scientific queries
Name 1645 0
Dr N K Briffa
Address 1645 0
School of Physiotherapy
Curtin University of Technology
Bentley
WA
Country 1645 0
Australia
Phone 1645 0
(08)92663666
Fax 1645 0
Email 1645 0
[email protected]

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
SourceTitleYear of PublicationDOI
EmbaseSelf-management for osteoarthritis of the knee; health professionals or lay leaders?.2009https://dx.doi.org/10.1002/art.27103
N.B. These documents automatically identified may not have been verified by the study sponsor.