Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000174583
Ethics application status
Approved
Date submitted
12/05/2006
Date registered
12/05/2006
Date last updated
1/08/2011
Type of registration
Prospectively registered

Titles & IDs
Public title
Can patient self-management education programs improve outcomes of people with osteoarthritis?
Scientific title
Can patient self-management education programs improve Health-Related Quality of Life in people with moderate to severe hip or knee osteoarthritis?
Secondary ID [1] 260 0
National Health and Medical Research Council (NHMRC): 400210
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Moderate to severe hip or knee osteoarthritis 1147 0
Condition category
Condition code
Musculoskeletal 1227 1227 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will be recruited from outpatient orthopaedic and rheumatology clinics at Cabrini Hospital, Austin Hospital, The Northern Hospital, Alfred Hospital, Epworth Hospital, Frankston Hospital and Geelong Hospital. Participants will be randomly allocated to either an intervention group or a control group. The intervention group will undergo a 6-week Arthritis Self-Management Program, involving 1 session per week (each session is 2.5 hours) and will also receive an Arthritis Self-Management book.
Intervention code [1] 1014 0
Other interventions
Comparator / control treatment
The control group will not undergo the Arthritis Self-Management program but will receive an Arthritis Self-Management book.
Control group
Active

Outcomes
Primary outcome [1] 1665 0
The primary outcome is Health-Related Quality of Life (HRQoL) measured using the Assessment of Quality of Life (AQoL) instrument.
Timepoint [1] 1665 0
HRQoL will also be measured at baseline, 3 months and 12 months.
Secondary outcome [1] 2975 0
1. Health Education Impact Questionnaire (HEI-Q) score.
Timepoint [1] 2975 0
Measured at baseline, 6 weeks, 3 months and 12 months
Secondary outcome [2] 2976 0
2. Western Ontario and McMaster Universities Osteoarthritis (WOMAC) Index score.
Timepoint [2] 2976 0
Measured at baseline, 3 months and 12 months
Secondary outcome [3] 2977 0
3. Management and Prioritisation Tool (MAPT) score.
Timepoint [3] 2977 0
Measured at baseline, 6 weeks, 3 months and 12 months
Secondary outcome [4] 2978 0
4. Kessler Psychological Distress (K10) scale score. Measured at baseline, 3 months and 12 months
Timepoint [4] 2978 0
Measured at baseline, 3 months and 12 months
Secondary outcome [5] 2979 0
5. Use of health services.
Timepoint [5] 2979 0
Collected at baseline, 3 months and 12 months
Secondary outcome [6] 2980 0
In addition to completing written questionnaires, 100 participants will be asked to undergo up to 2 qualitative interviews by telephone.
Timepoint [6] 2980 0
At baseline and/or 6 weeks

Eligibility
Key inclusion criteria
1. Hip or knee osteoarthritis for which the patient has been referred to or consulted an orthopaedic surgeon or rheumatologist . 2. Able to complete written questionnaires in English 3. A reasonable expectation that the 6 sessions of the Arthritis Self-Management Program can be attended
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients on an orthopaedic waiting list for joint replacement surgery or scheduled joint replacement surgery 2. Cognitive dysfunction 3. Previous participation in an Arthritis Self-Management 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)
Group allocation will be concealed using sealed opaque envelopes to be opened by a research assistant at the Centre for Rheumatic Diseases, The University of Melbourne after receipt of a signed written consent form.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation will be assigned after stratification by hopsital site according to a computer-generated table of random numbers using an uneven numbers block design. A second randomisation procedure will be used to select 100 participants to participate in qualitative telephone interviews.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1339 0
Government body
Name [1] 1339 0
National Health and Medical Research Council
Country [1] 1339 0
Australia
Primary sponsor type
University
Name
The University of Melbourne
Address
Parkville VIC 3010
Country
Australia
Secondary sponsor category [1] 1182 0
None
Name [1] 1182 0
N/A
Address [1] 1182 0
Country [1] 1182 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2688 0
Barwon Health
Ethics committee address [1] 2688 0
Ethics committee country [1] 2688 0
Australia
Date submitted for ethics approval [1] 2688 0
14/04/2006
Approval date [1] 2688 0
28/06/2006
Ethics approval number [1] 2688 0
06/11
Ethics committee name [2] 2689 0
The University of Melbourne
Ethics committee address [2] 2689 0
Ethics committee country [2] 2689 0
Australia
Date submitted for ethics approval [2] 2689 0
Approval date [2] 2689 0
01/05/2006
Ethics approval number [2] 2689 0
060296
Ethics committee name [3] 2690 0
Cabrini Hospital
Ethics committee address [3] 2690 0
Ethics committee country [3] 2690 0
Australia
Date submitted for ethics approval [3] 2690 0
10/05/2006
Approval date [3] 2690 0
14/06/2006
Ethics approval number [3] 2690 0
02-29-05-06
Ethics committee name [4] 2691 0
Austin Health
Ethics committee address [4] 2691 0
Ethics committee country [4] 2691 0
Australia
Date submitted for ethics approval [4] 2691 0
09/10/2006
Approval date [4] 2691 0
24/01/2007
Ethics approval number [4] 2691 0
H2007/02694
Ethics committee name [5] 2692 0
Epworth Hospital
Ethics committee address [5] 2692 0
Ethics committee country [5] 2692 0
Australia
Date submitted for ethics approval [5] 2692 0
05/06/2006
Approval date [5] 2692 0
26/07/2006
Ethics approval number [5] 2692 0
34706
Ethics committee name [6] 4641 0
The Alfred hospital
Ethics committee address [6] 4641 0
Ethics committee country [6] 4641 0
Australia
Date submitted for ethics approval [6] 4641 0
26/07/2007
Approval date [6] 4641 0
31/07/2007
Ethics approval number [6] 4641 0
154/07
Ethics committee name [7] 4642 0
Northern Health
Ethics committee address [7] 4642 0
Ethics committee country [7] 4642 0
Australia
Date submitted for ethics approval [7] 4642 0
04/07/2007
Approval date [7] 4642 0
30/07/2007
Ethics approval number [7] 4642 0
26/07
Ethics committee name [8] 4940 0
Frankston Hospital - Peninsula Health
Ethics committee address [8] 4940 0
Ethics committee country [8] 4940 0
Australia
Date submitted for ethics approval [8] 4940 0
04/07/2007
Approval date [8] 4940 0
27/11/2007
Ethics approval number [8] 4940 0
2007-21

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

Contacts
Principal investigator
Name 35737 0
Address 35737 0
Country 35737 0
Phone 35737 0
Fax 35737 0
Email 35737 0
Contact person for public queries
Name 10203 0
Bianca Chan
Address 10203 0
Centre for Rheumatic Diseases
Department of Medicine
The University of Melbourne
Royal Melbourne Hospital
Parkville VIC 3050
Country 10203 0
Australia
Phone 10203 0
+61 3 8344 3142
Fax 10203 0
+61 3 93427632
Email 10203 0
bianca.chan@mh.org.au
Contact person for scientific queries
Name 1131 0
Dr Richard Osborne
Address 1131 0
Centre for Rheumatic Diseases
Department of Medicine
The University of Melbourne
Royal Melbourne Hospital
Parkville VIC 3050
Country 1131 0
Australia
Phone 1131 0
+61 3 83443148
Fax 1131 0
+61 3 93427632
Email 1131 0
richardo@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
No additional documents have been identified.