Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000338662
Ethics application status
Approved
Date submitted
6/09/2005
Date registered
8/09/2005
Date last updated
22/01/2008
Type of registration
Prospectively registered

Titles & IDs
Public title
The Southern Adelaide Waiting List Project: A Regional Partners in Health Approach with a Call-Centre Support System.
Scientific title
A randomized controlled trial to determine the effectiveness of chronic disease self management in people with osteoarthritis awaiting joint replacement surgery to improve their health related quality of life
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Individuals with either Osteo or Rheumatoid Arthritis on a procedural waiting list for Knee or Hip Replacement. 431 0
Condition category
Condition code
Inflammatory and Immune System 501 501 0 0
Rheumatoid arthritis
Musculoskeletal 502 502 0 0
Osteoarthritis

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Partners in Health chronic disease self management is a clinician focused approach which provides health professionals with the tools to work in partnership with individuals with chronic illness to maximise their self management capacity.
The generic patient-centred assessment using a Partners in Health scale, Cue and Response interview and Problems / goal identification results in a care plan that describes which services and self management goals will be addressed over a 6 month period.
Partners in Health will be linked to a telephone support system manned by trained non medical personnel (and managed by Arthritis South Australia).
Intervention code [1] 363 0
None
Comparator / control treatment
Active follow-up without receiving Partners in Health chronic disease self management.
Control group
Active

Outcomes
Primary outcome [1] 573 0
HEI-Q
Timepoint [1] 573 0
At baseline and 6 months
Secondary outcome [1] 1222 0
AQoL
Timepoint [1] 1222 0
At baseline and six months
Secondary outcome [2] 1223 0
CES-D BMQ
Timepoint [2] 1223 0
At baseline and six months

Eligibility
Key inclusion criteria
Confirmed allocation as Non-Urgent status to a southern region. Joint Replacement waiting list.
Minimum age
Not stated
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Mini-Mental score<24, unable to read and speak English, unable to complete the 6-month follow-up, significant frailty or illness that will make protocol completion unlikely, living outside the southern region of Adelaide, urgent or semi-urgent category status.

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)
Trial allocation will be kept in sequential, sealed opaque envelopes will be prepared by the study biostatistician. Allocation to groups will be managed by the centralised randomisation service of the Repatriation General Hospital Pharmacy Department.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer-generated randomisation schedule will be prepared by the study biostatistician. To ensure equal representation of people awaiting knee and hip surgery in both groups, the allocation schedule will be stratified by affected joint.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
3/10/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
250
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 564 0
Charities/Societies/Foundations
Name [1] 564 0
Royal College of Physicians
Country [1] 564 0
United Kingdom
Funding source category [2] 565 0
Government body
Name [2] 565 0
Department of Health and Ageing Arthritis and Musculoskeletal Quality Improvement Program
Country [2] 565 0
Australia
Primary sponsor type
Individual
Name
Professor Maria Crotty
Address
Department of Rehabilitation and Aged Care Flinders University Repatriation General Hospital Daws Rd Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 457 0
None
Name [1] 457 0
None
Address [1] 457 0
Country [1] 457 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 1586 0
Flinders University/Medical Centre
Ethics committee address [1] 1586 0
Ethics committee country [1] 1586 0
Australia
Date submitted for ethics approval [1] 1586 0
Approval date [1] 1586 0
Ethics approval number [1] 1586 0
Ethics committee name [2] 1587 0
Repatriation General Hospital
Ethics committee address [2] 1587 0
Ethics committee country [2] 1587 0
Australia
Date submitted for ethics approval [2] 1587 0
Approval date [2] 1587 0
Ethics approval number [2] 1587 0

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

Contacts
Principal investigator
Name 35237 0
Address 35237 0
Country 35237 0
Phone 35237 0
Fax 35237 0
Email 35237 0
Contact person for public queries
Name 9552 0
Professor Maria Crotty
Address 9552 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 9552 0
Australia
Phone 9552 0
+61 8 82751103
Fax 9552 0
+61 8 82751130
Email 9552 0
[email protected]
Contact person for scientific queries
Name 480 0
Professor Maria Crotty
Address 480 0
Department of Rehabilitation and Aged Care
Flinders University
Repatriation General Hospital
Daws Rd
Daw Park SA 5041
Country 480 0
Australia
Phone 480 0
+61 8 82751103
Fax 480 0
+61 8 82751130
Email 480 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
No additional documents have been identified.