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Trial registered on ANZCTR


Registration number
ACTRN12609000726257
Ethics application status
Approved
Date submitted
17/08/2009
Date registered
24/08/2009
Date last updated
29/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised Control Trial of the Flinders Model of Self-Management support for older Australians with complex chronic diseases, and their carers.
Scientific title
An efficacy trial testing whether older Australians (aged 60 years or more) with complex chronic disease (2 or more conditions) who receive the Flinders Model of Self-Management support program experience improved health status and reduced burden on carers (i.e. spouses) compared to those who receive a health education program.
Secondary ID [1] 295364 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular disease (including: ischaemic heart disease, cerebrovascular disease/stroke, peripheral vascular disease, congestive heart failure, hypertension). 243436 0
Respiratory (including: asthma, chronic obstructive pulmonary disease). 243437 0
Musculoskeletal (including: osteoarthritis, rheumatoid arthritis, other arthritis, osteoporosis, chronic back pain). 243438 0
Psychological (including: depression, anxiety, insomnia). 243439 0
Digestive (including: gastro-oesophageal reflux disease). 243440 0
Kidney disease 243441 0
Diabetes (Type 1 or Type 2). 243442 0
Non-end stage cancers. 243443 0
Condition category
Condition code
Public Health 239740 239740 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention group will receive the Flinders Model of Self-Management (Flinders Model). The Flinders Model provides a generic set of tools that enable health professionals to undertake a structured assessment of self-management behaviours, collaborative identification of problems and goal setting leading to the development of individualised self-management care plans. The Flinders Model is generic and not disease specific.

The intervention will comprise a total of three home visits and four follow-up phone calls conducted over a six month period by health professionals (e.g. nurses, occupational therapists, social workers, psychologists) trained in the Flinders Model.

Participants in the intervention group will also receive their usual medical care throughout the trial.
Intervention code [1] 237061 0
Behaviour
Comparator / control treatment
Participants in the attention control group (Health Education) will receive a package of educational materials targeted to their specific health conditions. This package will be designed by a chief investigator who has considerable experience in the development of educational health promotion and prevention resource materials.

The health professionals who deliver this package will make three home visits and four follow-up phone calls over a six month period (the same as staff implementing the Flinders Model). Health professionals delivering the attention control will provide support, encouragement and empathy to clients but will not address formal self-management skills. The integrity of this intervention will be monitored by a chief investigator.

Participants in the attention control group will receive their usual medical care throughout the trial.
Control group
Active

Outcomes
Primary outcome [1] 240491 0
Health Status.

This measure includes questions about self-rated health, health distress, illness intrusiveness, pain, energy, fatigue and depression.

These items are from evaluation tools developed at the Stanford Patient Education Research Centre.
Timepoint [1] 240491 0
Baseline and final measurement at completion of a 6 month intervention.
Primary outcome [2] 240492 0
Health Behaviours.

This measure includes questions about exercise behaviours (using the Stanford evaluation tools) and medication adherence (using the Medication Adherence Report Scale or MARS-5 by Horne & Weinman, 1999).
Timepoint [2] 240492 0
Baseline and final measurement at completion of a 6 month intervention.
Primary outcome [3] 240493 0
Perceived self-efficacy.

This measure is one of the Stanford evaluation tools.
Timepoint [3] 240493 0
Baseline and final measurement at completion of a 6 month intervention.
Primary outcome [4] 240494 0
Health Services Utilisation.

This measure is one of the Stanford evaluation tools.
Timepoint [4] 240494 0
Baseline and final measurement at completion of a 6 month intervention.
Primary outcome [5] 240662 0
The primary outcome measure for carers is the Caregiver Risk Screen (Guberman, Keefe, Fancey, Nahmiash & Barylak, 2001).
Timepoint [5] 240662 0
Baseline and final measurement at completion of a 6 month intervention.
Secondary outcome [1] 257041 0
The Health Education Impact Questionnaire (heiQ) for both patients and carers (Osborne, Whitfield & Elsworth, 2007).
Timepoint [1] 257041 0
Baseline and final measurement at completion of a 6 month intervention.

Eligibility
Key inclusion criteria
Participants will be aged 60 years or older with two or more of the following types of chronic conditions:
- Cardiovascular (including: ischaemic heart disease, cerebrovascular disease/stroke, peripheral vascular disease, congestive heart failure, hypertension);
- Respiratory (including: asthma, chronic obstructive pulmonary disease);
- Musculoskeletal (including: osteoarthritis, rheumatoid arthritis, other arthritis, osteoporosis, chronic back pain);
- Psychological (including: depression, anxiety, insomnia);
- Digestive (including: gastro-oesophageal reflux disease);
- Kidney disease
- Diabetes (Type 1 or Type 2); and
- Cancer.
Minimum age
60 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will not be eligible for the study if they:
- Have a clinically dominant disease likely to shorten life expectancy (e.g. late stage cancer)
- Are unable to comprehend English.
- Suffer from significant cognitive impairment.
- Are severely depressed.
- Are currently actively involved in a Chronic Disease Self-Management (CDSM) 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)
Central randomisation by phone call to hospital pharmacy where allocation schedule is held.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple permuted block randomisation (randomly arranged to maintain allocation concealment) will be used with stratification by gender and carer availability. STATA statistical software will generate these blocks.
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)
SA

Funding & Sponsors
Funding source category [1] 237434 0
Government body
Name [1] 237434 0
Australian Government Department of Health and Ageing
Address [1] 237434 0
Integration and Self-Management Section
Chronic Disease Branch
GPO Box 9848
Canberra ACT 2601
Country [1] 237434 0
Australia
Primary sponsor type
University
Name
Flinders University
Address
Discipline of General Practice
Level 3, Health Sciences Building
Registry Rd
Bedford Park SA 5042
Country
Australia
Secondary sponsor category [1] 236950 0
None
Name [1] 236950 0
Address [1] 236950 0
Country [1] 236950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239562 0
Flinders Clinical Research Ethics Committee
Ethics committee address [1] 239562 0
Human Research and Ethics Department
Southern Adelaide Health Service Room 2A 221
Flinders Medical Centre
Bedford Park SA 5042
Ethics committee country [1] 239562 0
Australia
Date submitted for ethics approval [1] 239562 0
Approval date [1] 239562 0
23/07/2009
Ethics approval number [1] 239562 0
EC00188

Summary
Brief summary
The aim of the trial is to address the current lack of evidence for what is arguably Australia's most widely used chronic disease self-management program, the Flinders Model.

It is hypothesised that older Australians who receive the Flinders Model of Self-Management support program will experience improved health status compared to those who receive a health education package.

A secondary objective of the study is to ascertain the impact of the Flinders Model on spouses (‘carers’) who care for those with complex chronic disease. It is unknown whether the Flinders Model will increase or decrease carer burden and stress.
Trial website
Trial related presentations / publications
Reed, R., Roeger, L., Howard, S., Oliver-Baxter, J.M., Battersby, M.W., Bond, M., et al. (2018). A self-management support for older Australians with multiple chronic conditions – a randomised controlled trial. MJA Medical Journal of Australia, 208(2) pp. 69-74.
[10.5694/mja17.00127]

Reed, R., Barton, C., Isherwood, L., Oliver-Baxter, J. and Roeger, S. (2013). Recruitment for a Clinical Trial of Chronic Disease Self-management for Older Adults with Multimorbidity: A Successful Approach within General Practice. BMC Family Practice, 14(125) pp. 1-7.
[10.1186/1471-2296-14-125]

Reed, R., Battersby, M., Osborne, R., Bond, M., Howard, S. and Roeger, S. (2011). Protocol for a randomised controlled trial of chronic disease self-management support for older Australians with multiple chronic diseases. Contemporary Clinical Trials, 32(6) pp. 946-952.
[10.1016/j.cct.2011.08.001]

Masters, S., Oliver-Baxter, J., Barton, C.A., Summers, M., Howard, S., Roeger, S., et al. (2013). Programmes to support chronic disease self-management: should we be concerned about the impact on spouses? Health and Social Care in The Community, 21(3) pp. 315-326.
[10.1111/hsc.12020]

Public notes

Contacts
Principal investigator
Name 30002 0
Prof Richard Reed
Address 30002 0
Discipline of General Practice
Flinders University
GPO Box 2100
Adelaide 5000
Country 30002 0
Australia
Phone 30002 0
61 8 72218530
Fax 30002 0
Email 30002 0
richard.reed@flinders.edu.au
Contact person for public queries
Name 13249 0
Dr Dr Sara Howard
Address 13249 0
Rm 3.08 Level 3
General Practice
Health Sciences Building
Registry Rd
Bedford Park SA 5042
Country 13249 0
Australia
Phone 13249 0
+61 8 7221 8517
Fax 13249 0
+61 8 7221 8544
Email 13249 0
sara.howard@flinders.edu.au
Contact person for scientific queries
Name 4177 0
Dr Dr Sara Howard
Address 4177 0
Rm 3.08 Level 3
General Practice
Health Sciences Building
Registry Rd
Bedford Park SA 5042
Country 4177 0
Australia
Phone 4177 0
+61 8 7221 8517
Fax 4177 0
+61 8 7221 8544
Email 4177 0
sara.howard@flinders.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