Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000531617
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
27/09/2005
Date last updated
27/04/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Australian Integrated Mental Health Initiative
Scientific title
Australian Integrated Mental Health Initiative - Evidence based health promotion strategies to people with chronic or recurring mental disorders (CRMD) to improve mental health outcomes, reduce physical risks and promote social and community functioning - NHMRC Health Research Partnership.
Secondary ID [1] 280407 0
Nil
Universal Trial Number (UTN)
Trial acronym
AIMhi
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic or Recurring Mental Disorders 656 0
Condition category
Condition code
Mental Health 729 729 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Conducting trials of interventions for people with CRMD across three main streams (contexts): (i) High Support stream focuses on improving outcomes for CRMD patients who need high support interventions. Intervention priorities are (a) collaborative goal setting and homework that maximises ongoing self management of physical and mental health and (b) interventions that can be transported and sustained in multiple ; setting (rehabilitation /community case management). (ii) Rural stream examines interventions to reduce recurrence and to improve physical health behaviours in people with any chronic or recurring mental disorder, with particular emphasis on depression. Brief interventions by general practitioners and mental health staff will be supplemented by a series of correspondence based treatments (eg. for depression and alcohol misuse) and initiatives of self help organisations, services and local councils. (iii) The Indigenous stream aims to implement service and setting adapted interventions targeting CRMDs across the mental health spectrum of interventions (patient information systems, best practice specialist and primary care treatment protocols and models of service delivery, mental health outcome measures and community based support activities in order to obtain demonstrable improvements in mental health outcomes in 2 regions of remote northern Australia. Intervention programs will be conducted and evaluated for the duration of the study. Early detection (screening for chronic disease and provision of brief interventions in health issues including smoking exercise, nutrition, alcohol consumption and sexual health), best practice primary prevention and clinical care programs under the Chronic Disease Strategy is being implemented as a vehicle for improving the health status of rural and remote indigenous people.
Intervention code [1] 586 0
Other interventions
Comparator / control treatment
There is no comparator or control treatment in this study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 897 0
This overall project aims to apply evidence based health promotion strategies to people with chronic or recurring mental disorders (CRMD) in an attempt to improve mental health outcomes. Conducted across three streams, intervention trials will focus on (i) People in urban areas or regional centres who require high levels of support to improve outcomes for those in need high support; (ii) patients of primary care practitioners and mental health services in rural towns and regional centres. The rural stream aims to detect and prevent relapse in mental disorders; reduce risk of physical disorders associated with smoking, excessive alcohol use, unhealthy diet and low activity levels. (iii) Indigenous consumers of mental health services in remote areas and examines contrasting models of mental health services and related information systems The approach incorporates principles and priorities of the 2nd National Mental Health Plan and attempts to increase the capacity of stakeholders to manage CRMD. It is designed to be sustainable and widely applicable. Overall the study seeks to develop and demonstrate sustainable methods of improving mental health outcomes. Strategic priorities include: enhanced responsiveness of practitioners and service systems to the health risks faced by people with chronic or recurring mental disorders.
Timepoint [1] 897 0
Baseline, Year 1, 2, 3, 4 and 5
Primary outcome [2] 898 0
This overall project aims to apply evidence based health promotion strategies to people with chronic or recurring mental disorders (CRMD) in an attempt to reduce physical risks. Conducted across three streams, intervention trials will focus on (i) People in urban areas or regional centres who require high levels of support to improve outcomes for those in need high support; (ii) patients of primary care practitioners and mental health services in rural towns and regional centres. The rural stream aims to detect and prevent relapse in mental disorders; reduce risk of physical disorders associated with smoking, excessive alcohol use, unhealthy diet and low activity levels. (iii) Indigenous consumers of mental health services in remote areas and examines contrasting models of mental health services and related information systems The approach incorporates principles and priorities of the 2nd National Mental Health Plan and attempts to increase the capacity of stakeholders to manage CRMD. It is designed to be sustainable and widely applicable. Overall the study seeks to develop and demonstrate sustainable methods of improving mental health outcomes. Strategic priorities include: enhanced responsiveness of practitioners and service systems to the health risks faced by people with chronic or recurring mental disorders.
Timepoint [2] 898 0
Baseline, Year 1, 2, 3, 4 and 5
Primary outcome [3] 899 0
This overall project aims to apply evidence based health promotion strategies to people with chronic or recurring mental disorders (CRMD) in an attempt to promote social and community functioning. Conducted across three streams, intervention trials will focus on (i) People in urban areas or regional centres who require high levels of support to improve outcomes for those in need high support; (ii) patients of primary care practitioners and mental health services in rural towns and regional centres. The rural stream aims to detect and prevent relapse in mental disorders; reduce risk of physical disorders associated with smoking, excessive alcohol use, unhealthy diet and low activity levels. (iii) Indigenous consumers of mental health services in remote areas and examines contrasting models of mental health services and related information systems The approach incorporates principles and priorities of the 2nd National Mental Health Plan and attempts to increase the capacity of stakeholders to manage CRMD. It is designed to be sustainable and widely applicable. Overall the study seeks to develop and demonstrate sustainable methods of improving mental health outcomes. Strategic priorities include: enhanced responsiveness of practitioners and service systems to the health risks faced by people with chronic or recurring mental disorders.
Timepoint [3] 899 0
Baseline, Year 1, 2, 3, 4 and 5
Secondary outcome [1] 1755 0
The project has the larger long term objective of providing methods that can be sustained and disseminated across Australia. By combining three research streams in very different contexts, the project produces intervention variants that can be applied across Australia. The empowerment and support of practitioners and other service providers is crucial to providing sustainable, integrated and accessible services. CRMD has a substantial impact on early mortality, morbidity and associated burden and financial cost in Australia, particularly in indigenous populations. Access to best practice in CRMD is variable, with remote areas and indigenous populations being especially disadvantaged. This project addresses these issues through training and support for health care providers and carers. Emphasising service integration, especially between mental health and general practice providers. Involving policy makers and users from its inception and developing increased awareness and capacity in practitioners sustainability will be maximised.
Timepoint [1] 1755 0
Baseline, Year 1, 2, 3, 4 and 5

Eligibility
Key inclusion criteria
Each stream have specific inclusion and exclusion criteria for recruitment of both patients and professionals (clinician, practitioners and mental health service provider). (i) High Support: clinician recruitment -a total of 140 clinicians working with people with CRMD will be recruited and randomly allocated to immediate or delayed interventions. Eligibility requires that they are working actively with at least 3 patients who meet patient eligibility; patient recruitment - 840 patients will be randomly allocated from caseload in each condition. Patients are to be: 18 years or over; diagnosis of psychotic disorder or at least 6 months duration.
inclusion of patients with comorbid substance misuse or personality disorders is allowed; "high support needs on the CANSAS scale. (ii) Rural Stream: Participants include 6 groups: (60) GPs in Qld;(approx 70) mental health staff in participating towns (4 pairs of rural centres) to receive immediate or delayed interventions; cross sectional patients (minimum of 10 with CRMD from each GP and a minimum of 20 patients surveyed from each GP (all are sampled from the waiting rooms of all participating GPs); Longitudinal patient sample: 240 patients to be recruited from GP and Mental Health Services. Adults with a history of treatment by antidepressants, mood stabilisers, antipsychotics with an DSM-IV disorder with at least 6 months duration; comorbidity will not result in exclusion.
A community sample will be recruited from each town (50 surveys per town at each assessment) Focus groups: participants will be adults with CRMD and carers; key community representatives, GPs and mental health staff (6-10 in each group, 1 group of each type in each town) . (iii) Indigenous people in remote communities for Far North Queensland (from approx total population 15000) and Top End of the Northern Territory (from approx total population of 25,000) suffering from chronic and relapsing mental illness and their families. It will utilise existing primary care and specialist mental health consultancy services and build on a set of existing initiatives across two service settings.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion of patients with dementia, moderate or severe mental retardation, brain injury;
Patients with dementia and severe mental retardation or brain injury will be excluded.

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
Other
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/05/2003
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
1000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 810 0
Government body
Name [1] 810 0
NHMRC Health Research Partnership Grant
Country [1] 810 0
Australia
Funding source category [2] 3718 0
Other
Name [2] 3718 0
Queensland Health
Country [2] 3718 0
Australia
Primary sponsor type
Individual
Name
Professor David Kavanagh (& Rural Stream)
Address
IHBI, 60 Musk Ave, Kelvin Grove, QLD, 4059
Country
Australia
Secondary sponsor category [1] 669 0
Individual
Name [1] 669 0
Professor Ernest Hunter (Indigenous)
Address [1] 669 0
PO Box 1103, Cairns, QLD, 4870
Country [1] 669 0
Australia
Secondary sponsor category [2] 670 0
Individual
Name [2] 670 0
Professor Frank Deane (High Support)
Address [2] 670 0
Faculty of Health & Behavioural Sciences
University of Wollongong
Wollongong NSW 2522
Country [2] 670 0
Australia
Secondary sponsor category [3] 671 0
Individual
Name [3] 671 0
Dr Robert King
Address [3] 671 0
School of Medicine, K floor, Mental Health Centre, RBWH, Herston, QLD, 4029
Country [3] 671 0
Australia
Secondary sponsor category [4] 672 0
Individual
Name [4] 672 0
Dr Melissa Haswell Elkins
Address [4] 672 0
School of Population Health
University of Queensland
PO Box 1103
Cairns QLD 4870
Country [4] 672 0
Australia
Secondary sponsor category [5] 673 0
Individual
Name [5] 673 0
Dr Tricia Nagel
Address [5] 673 0
Menzies School of Health Research,
PO Box 41096,
CASUARINA NT 0810
Country [5] 673 0
Australia
Secondary sponsor category [6] 674 0
Individual
Name [6] 674 0
Dr Lindsay Oades
Address [6] 674 0
Faculty of Health & Behavioural Sciences
University of Wollongong
Wollongong NSW 2522
Country [6] 674 0
Australia
Secondary sponsor category [7] 675 0
Individual
Name [7] 675 0
Professor Cindy Gallois
Address [7] 675 0
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country [7] 675 0
Australia
Secondary sponsor category [8] 676 0
Individual
Name [8] 676 0
Professor Helen Bartlett
Address [8] 676 0
Australasian Centre on Ageing
The University of Queensland
St Lucia Qld 4072
Country [8] 676 0
Australia
Secondary sponsor category [9] 677 0
Individual
Name [9] 677 0
Dr Merrill Turpin
Address [9] 677 0
Sciences, University of Queensland, Brisbane, QLD, 4072
Country [9] 677 0
Australia
Secondary sponsor category [10] 678 0
Individual
Name [10] 678 0
Professor Chris Del Mar
Address [10] 678 0
Faculty of Health Sciences and Medicine, Bond University, QLD, 4229
Country [10] 678 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2077 0
University of Queensland
Ethics committee address [1] 2077 0
Ethics committee country [1] 2077 0
Australia
Date submitted for ethics approval [1] 2077 0
Approval date [1] 2077 0
Ethics approval number [1] 2077 0
Ethics committee name [2] 2078 0
University of Wollongong
Ethics committee address [2] 2078 0
Ethics committee country [2] 2078 0
Australia
Date submitted for ethics approval [2] 2078 0
Approval date [2] 2078 0
Ethics approval number [2] 2078 0

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

Contacts
Principal investigator
Name 36129 0
Address 36129 0
Country 36129 0
Phone 36129 0
Fax 36129 0
Email 36129 0
Contact person for public queries
Name 9775 0
Professor David Kavanagh
Address 9775 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 9775 0
Australia
Phone 9775 0
+61 7 31386143
Fax 9775 0
+61 7 31386030
Email 9775 0
[email protected]
Contact person for scientific queries
Name 703 0
Professor David Kavanagh
Address 703 0
IHBI, GPO Box 2434, Brisbane QLD 4001
Country 703 0
Australia
Phone 703 0
+61 7 31386143
Fax 703 0
+61 7 31386030
Email 703 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.