Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612001231831
Ethics application status
Approved
Date submitted
19/11/2012
Date registered
21/11/2012
Date last updated
21/11/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Promoting Health Self Management by People Living With Mental Illness.
Scientific title
The Flinders Program of Chronic Condition Management can be effectively administered in non-clinical settings to encourage people living with mental illness to self manage their physical health
Secondary ID [1] 281567 0
NIL
Universal Trial Number (UTN)
U1111-1136-9549
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental disorders 287843 0
Co morbid physical health condition resulting from mental disorder 287844 0
Condition category
Condition code
Public Health 288205 288205 0 0
Health promotion/education

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1 Intervention Group: Flinders Program (FP) of Chronic Condition Management (FP + health promotional materials + support as usual)
Mental health workers in the non-government mental health sector typically offer non-clinical psychosocial support for up to two years. The project will train these workers in the FP so that they can offer clients assistance to learn health self management skills.
The aim of the Flingers Program is the provision of a consistent, reproducible approach to assessing key components of self-management. Specifically the individual and his/her support person collaboratively identify issues which enables the better targeting of interventions. It is argued that the motivational process involved leads to sustained behaviour change and is related to improvement in health outcomes. The Flinders program is a four step intervention conducted during a consumer’s routine contact times with support workers assisting the individual to make plans and set goals. Clients, NGO support workers and mental health and primary care providers will collaborate to implement the care plans. The health promotion resource materials to be ofeered to pariticpants are chiefly life-style related printed materials (e.g. nutrition and physical activity guidelines, Quit and alcohol management guidelines, physical health screening recommendations etc.) and practical materials such as portion control plates, tape measures, pedometers, basebal caps, Recipies for Life packs, MindBodyLife Food mood diaries; toothbrishes ands toothpaste.
The workers will review FP tools with clients every three months during the normal course of their interactions. It is anticipated that participants will be supported for up to two years.

The four components of the Flinders Program are:
1. The Partners in Health Activity (PIH): The PIH is a Likert self-rated 12 item questionnaire that is based on the six principles of self-management completed by the person with chronic conditions to measure their current self-management knowledge, skills, capacities and the psychosocial impacts of their conditions on their quality of life. It is amenable to repeat measures at set intervals.
2. The Cue and Response Activity (C&R): The C&R interview is an adjunct to the PIH scale. The C&R interview takes approximately 30 to 45 minutes in which the worker uses a series of open-ended questions or cues to explore the individual’s responses to the PIH scale in depth. It enables the barriers to self-management to be explored.
3. The Problem and Goal Assessment (P&G): The Problem & Goal assessment enables the person to identify their greatest problem, which may or may not be related to their health issues, and to set goal(s) around this problem. The individual sets a medium term goal which if achieved will reduce the severity of the problem. The assessment takes between 5-10 minutes to complete. Both the problem and the goal are Likert self-rated by the consumer allowing repeat measure over time.
4. Collaborative Care Plan: The Care Plan contains the issues identified from the C&R interview that the individual and the worker have collaboratively agreed are areas needing work over the coming 6 months. It identifies the issues, aims, actions to address the issues, by whom, by when, including potential others within the team or other services who may assist in providing self-management support.

Other measures to which all participants will be exposed are:
5. The Medical Outcomes Survey Short Form 8 (MOS-SF8) Is an 8-item self report quality of life scale
6. Physical Health Measures: All participants at the participating clinical mental health services will be tested according to the Metabolic Syndrome Screening Algorithm . The measures are blood pressure, waist circumference, blood sugars, and blood lipids. This screening will take place at the participating health services or by GP’s and will be part of the care participants routinely receive.
7. A self administered survey to assess resource use in terms of medical and inpatient visits: This survey will assess the number of GP or emergency department visits made in the previous 6 months and what treatment if any was received. The purpose of this survey is to observe whether any changes to the pattern of medical attention sought by participants occurred over time.
8. The Patient Assessment of Chronic Illness Care (PACIC) is a 20-item self-report scale assessing consumer perceptions about the quality of care they received in managing their condition, and will be administered at the end of the project.
Intervention code [1] 286079 0
Early detection / Screening
Intervention code [2] 286080 0
Prevention
Intervention code [3] 286081 0
Lifestyle
Comparator / control treatment
Arm 2 Control Group: (health promotional materials + support as usual). See above for details of what constitutes support as usual and health promotional materials.
Control group
Active

Outcomes
Primary outcome [1] 288388 0
Primary Outcome 1 The aim is to investigate whether Metabolic Screening results for the intervention group will be significantly lower than the same results for the control group. Screening for the Metabolic Syndrome comprises four measures: Blood pressure, waist circumference, fasting blood glucose and blood lipids. This screening will take place at the participating health services or by GPs and will be part of the care participants routinely receive.
Participants will sign a release of information form allowing the research team to contact medical care provides for this information.
Timepoint [1] 288388 0
Time point: Base line (the same) and at 2 years
Primary outcome [2] 288389 0
Primary Outcome 2: The intervention groupwill be more satisfied with their chronic condition care than the control group as measured by the Patient Assessment of Chronic Care Survey.
Timepoint [2] 288389 0
Time point: At 2 years.
Primary outcome [3] 288390 0
Primary Outcome 3: Increased self- management capacity (Partners in Health Scale and Problems and Goals Activity)_
Timepoint [3] 288390 0
Time point: Base line and at 2 years
Secondary outcome [1] 300020 0
Secondary Outcome1 Quality of Life as measured by MOS SF-8. The Medical Outcomes Survey Short Form 8 (MOS-SF8) Is an 8-item self report quality of life scale
Timepoint [1] 300020 0
Time point Baseline and 2 years.

Eligibility
Key inclusion criteria
ICD 10 Mental Health diagnosis
18-65 Ye4ars of Age
At risk of or have developed a chronic co morbid physical health condition
Able to give informed consent
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Organic brain disorders (e.g. Alzheimer’s disease), acquired brain injury, under guardianship

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not 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
Recruiting
Date of first participant enrolment
Anticipated
1/09/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 6029 0
6005
Recruitment postcode(s) [2] 6030 0
6111
Recruitment postcode(s) [3] 6031 0
6016
Recruitment postcode(s) [4] 6032 0
6019
Recruitment postcode(s) [5] 6033 0
6030
Recruitment postcode(s) [6] 6034 0
6054
Recruitment postcode(s) [7] 6035 0
6056
Recruitment postcode(s) [8] 6036 0
6160
Recruitment postcode(s) [9] 6037 0
6168
Recruitment postcode(s) [10] 6038 0
6230
Recruitment postcode(s) [11] 6039 0
6401
Recruitment postcode(s) [12] 6040 0
6566

Funding & Sponsors
Funding source category [1] 286346 0
Charities/Societies/Foundations
Name [1] 286346 0
The Western Australian Health Promotion Foundation (Healthway) Health Promotion Research Grant
Country [1] 286346 0
Australia
Primary sponsor type
University
Name
The University of Western Australia
Address
35 Stirling highway Crawley 6009 Western Australia
Country
Australia
Secondary sponsor category [1] 285135 0
None
Name [1] 285135 0
Address [1] 285135 0
Country [1] 285135 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288422 0
The University of Western Australia
Ethics committee address [1] 288422 0
35 Stirling Highway Crawley 6009 WA
Ethics committee country [1] 288422 0
Australia
Date submitted for ethics approval [1] 288422 0
Approval date [1] 288422 0
27/07/2012
Ethics approval number [1] 288422 0
RA/4/1/5549
Ethics committee name [2] 288423 0
Government of Western Australia South Metropolitan Area Health Service
Ethics committee address [2] 288423 0
C/- Fremantle hospital, I Alma Street Fremantle WA 6160
Ethics committee country [2] 288423 0
Australia
Date submitted for ethics approval [2] 288423 0
Approval date [2] 288423 0
02/07/2012
Ethics approval number [2] 288423 0
1/12/0154
Ethics committee name [3] 288424 0
Government of Western Australia WACHS Research Ethics Committee
Ethics committee address [3] 288424 0
Level 1, 61 Victoria Street
BUNBURY WA 6230
Ethics committee country [3] 288424 0
Australia
Date submitted for ethics approval [3] 288424 0
Approval date [3] 288424 0
24/08/2012
Ethics approval number [3] 288424 0
2012:27
Ethics committee name [4] 288425 0
Government of Western Australia North Metropolitan Health Service
Ethics committee address [4] 288425 0
Graylands Hospital; Locked Bag No. 1
PO CLAREMONT WA 6910
Ethics committee country [4] 288425 0
Australia
Date submitted for ethics approval [4] 288425 0
Approval date [4] 288425 0
Ethics approval number [4] 288425 0
1/10/2012

Summary
Brief summary
The project will be an intervention aimed at supporting adults with a mental illness who are at risk of developing or have developed chronic physical health conditions and who are living in the community to self-manage their physical health conditions. The project will be a controlled trial consisting of two groups of 40 participants each. The intervention group will receive the Flinders Program of Chronic Condition Management (CCM). This will be achieved through the training of non-clinical support workers, including peer support workers in community organisations in Western Australia in the Flinders Program of CCM which is an evidence-based, client driven, motivational and collaborative process for planning and delivering self-management support. The control group will receive health promotional materials. The project will run for 3 years.
Trial website
There is no trial website
Trial related presentations / publications
Kemp, V; Fisher, C. Battersby, M; Lawn, S., Bailey, S. Promoting physical health self-management by people living with mental illness. Paper presented at RANZCP Annual Congress, Hobart, May 2012
Kemp, V; Fisher, C. Battersby, M; Lawn, S., Bailey, S. Learning to self-manage: encouraging physical health self-management by people who live with mental illness ASPAC Conference, Perth June 2012
Public notes

Contacts
Principal investigator
Name 34967 0
Address 34967 0
Country 34967 0
Phone 34967 0
Fax 34967 0
Email 34967 0
Contact person for public queries
Name 18214 0
Ms Vivien Kemp
Address 18214 0
UWA School of Psychiatry & Clinical Neurosciences
Fremantle Hospital
W Block, L6, 1 Alma Street,
Fremantle, Western Australia 6160
Country 18214 0
Australia
Phone 18214 0
+61 8 9431 3438
Fax 18214 0
+61 8 9431 3407
Email 18214 0
[email protected]
Contact person for scientific queries
Name 9142 0
Prof Mohan Isaac
Address 9142 0
UWA School of Psychiatry & Clinical Neurosciences
Fremantle Hospital
W Block, L6, 1 Alma Street,
Fremantle, Western Australia 6160
Country 9142 0
Australia
Phone 9142 0
+61 8 9431 3474
Fax 9142 0
+61 8 9431 3407
Email 9142 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.