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Trial registered on ANZCTR


Registration number
ACTRN12615000674538
Ethics application status
Approved
Date submitted
11/06/2015
Date registered
29/06/2015
Date last updated
22/07/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
An evaluation of the Flinders Program to improve patient quality of life and self-management competencies in osteoarthritis and co-occurring obesity: A randomised controlled trial.
Scientific title
A randomised controlled trial evaluating the impacts of the self-management support Flinders Program on Health Related Quality of Life of obese osteoarthritis patients on a knee or hip replacement waiting list
Secondary ID [1] 286878 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hip arthroplasty due to osteoarthritis 295281 0
Knee arthroplasty due to osteoarthritis
 295282 0
Obesity (BMI of 30 or greater) 295355 0
Condition category
Condition code
Musculoskeletal 295531 295531 0 0
Osteoarthritis
Diet and Nutrition 295532 295532 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive the self-management support Flinder Program for six months.
Flinders Program is a one-to-one self-management support program. It involves a 1-hour face-to-face session during which a trained nurse and the participant identify and prioritise the issues due to the chronic condition(s) the participant has. They then agree on a care plan based upon goals established for prioritised issues.
Adherence to the intervention is monitored by weekly/fortnightly (based on a mutual agreement) phone calls.
Intervention code [1] 292057 0
Lifestyle
Intervention code [2] 292124 0
Treatment: Other
Comparator / control treatment
Control group will receive the standard care from the hospital. Standard care involves services provided by physios and general practitioners at the hospital, and also services provided by nurses at the hospital such as introducing the community services.
Control group
Active

Outcomes
Primary outcome [1] 295267 0
Health-Related Quality of Life assessed by SF-36
Timepoint [1] 295267 0
Baseline, 6 months, and 10 months
Secondary outcome [1] 315219 0
Self-management competency assessed by Partner In Health questionnaire
Timepoint [1] 315219 0
Baseline, 6 months, and 10 months
Secondary outcome [2] 315220 0
Obesity assessed by BMI, Waist Circumference, Waist to Height ratio, and percent body fat measured by Bioimpedance device ImpediMed SFB7
Timepoint [2] 315220 0
Baseline, 6 months, and 10 months

Eligibility
Key inclusion criteria
1-Indicated for a primary total knee or hip arthroplasty due to osteoarthritis
2-have a BMI of 30 kg/m2 or above
3-willingly provide signed informed consent form to participate in the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1-cannot or will not provide signed informed consent for participation in the study.
2-have an emotional or neurological condition that would pre-empt their ability or willingness to participate in the study including mental illness, intellectual disability, drug or alcohol abuse.
3-have had a surgery within the last three months
4-have dementia
5-Patients who have a pacemaker or ICD will be excluded from the bio-impedance test.

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)
Potential participants will be chosen from the Repatriation Hospital knee or hip arthroplasty waiting list who have a BMI of 30 or above. They will be sent the patient information sheet, and will be contacted by phone a week after to arrange a visit time if interested. During the arranged visit time, the investigator will explain the purposes, methods, possible risks and benefits of participating in the study. A biostatistician will generate randomised sequences, and the clinical trial pharmacy at Repatriation Hospital will perform the allocation. Allocation involves contacting the holder of the allocation schedule -at the clinical trial pharmacy- who is off-site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be blocked using varying block sizes, and will be stratified for BMI groups (30-34.9, 35-39.9, 40 and above), and gender.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Self-management support Flinders Program is a safe intervention, and little harm in the application of such a program is expected, therefore, the consequences of a type I error are not severe. Based on a type I error of 0.1, power of 80% and effect size of 0.6 and a two tailed test, the sample size is calculated to 72. With an anticipated drop out rate of 30%, the total sample size is calculated to be 94.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
7/07/2015
Actual
7/07/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
94
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 3896 0
Repatriation Hospital - Daw Park

Funding & Sponsors
Funding source category [1] 291438 0
Other
Name [1] 291438 0
International Musculoskeletal Research Institute
Country [1] 291438 0
Australia
Primary sponsor type
Other
Name
International Musculoskeletal Research Institute
Address
International Musculoskeletal Research Institute, B-Block, Repatriation General Hospital, Daws Rd, Daw Park SA 5041
Country
Australia
Secondary sponsor category [1] 290114 0
None
Name [1] 290114 0
Address [1] 290114 0
Country [1] 290114 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292989 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 292989 0
Ethics committee country [1] 292989 0
Australia
Date submitted for ethics approval [1] 292989 0
Approval date [1] 292989 0
02/04/2015
Ethics approval number [1] 292989 0
401.14

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

Contacts
Principal investigator
Name 57934 0
Prof Jegan Krishnan
Address 57934 0
Department of Orthopaedics, Flinders Medical Centre, Flinders Drive, Bedford Park, SA 5042
Country 57934 0
Australia
Phone 57934 0
+61, 8, 8204 4289
Fax 57934 0
Email 57934 0
jegan.krishnan@flinders.edu.au
Contact person for public queries
Name 57935 0
Ladan Sahafi
Address 57935 0
Flinders Human Behaviour & Health Research Unit, Margaret Tobin Centre, University Drive, Bedford Park, SA 5042
Country 57935 0
Australia
Phone 57935 0
+61, 4, 23892015
Fax 57935 0
Email 57935 0
ladan.sahafi@flinders.edu.au
Contact person for scientific queries
Name 57936 0
Ladan Sahafi
Address 57936 0
Flinders Human Behaviour & Health Research Unit, Margaret Tobin Centre, University Drive, Bedford Park, SA 5042
Country 57936 0
Australia
Phone 57936 0
+61, 4, 23892015
Fax 57936 0
Email 57936 0
ladan.sahafi@flinders.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
SourceTitleYear of PublicationDOI
EmbaseEfficacy of the Flinders chronic condition management program in obese patients with hip or knee osteoarthritis: A study rationale and protocol.2016https://dx.doi.org/10.4066/AMJ.2016.2658
N.B. These documents automatically identified may not have been verified by the study sponsor.