Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000979853
Ethics application status
Approved
Date submitted
10/09/2012
Date registered
11/09/2012
Date last updated
11/09/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact and cost of mental illness in the community.
Scientific title
Services, Pathways Access Research and Knowledge (SPARK study) - The feasibility of conducting a longitudinal population health study of mental health service users in rural South Australia.
Secondary ID [1] 281189 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental Health 287365 0
Public Health 287396 0
Condition category
Condition code
Mental Health 287695 287695 0 0
Depression
Public Health 287728 287728 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants will be asked to provide information through questionnaires on social, and occupational function, health behavior and Quality of Life (QoL) over 4 different time points in a 12 month period. These data will be linked with Medicare and SA health service utilization records (the type and frequency of service).
Intervention code [1] 285649 0
Not applicable
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 287944 0
The primary outcome variable will be quality of life as measured by SF -12.
Timepoint [1] 287944 0
At baseline, 3, 6 and 12 months.
Secondary outcome [1] 299101 0
Risk of chronic disease development over time
Tools:
The Kessler 10 Psychological Distress Scale (K10)
The work and social adjustment scale (WSAS)
Health behaviours questionnaire
Timepoint [1] 299101 0
At baseline, 3, 6 and 12 months.
Secondary outcome [2] 299156 0
Variations in chronic disease development risk and function levels based on client location, services accessed (frequency and type) and availability of services.
Tools:
Data linkage to Medicare and SA health service utilization records.
Timepoint [2] 299156 0
At baseline, 3, 6 and 12 months.
Secondary outcome [3] 299157 0
Predictors of effective and ineffective care interventions.
Tools:
Data linkage to Medicare and SA health service utilization records.
Timepoint [3] 299157 0
At baseline, 3, 6 and 12 months.
Secondary outcome [4] 299158 0
Social and environmental factors (location, demographics)
Timepoint [4] 299158 0
At baseline, 3, 6 and 12 months.
Secondary outcome [5] 299159 0
Care Providers (GPs, psychiatrists, mental health teams, NGO, allied health professionals)
Tools:
Data linkage to Medicare and SA health service utilization records.
Timepoint [5] 299159 0
At baseline, 3, 6 and 12 months.
Secondary outcome [6] 299160 0
Costs of mental illness to the community.
Tools:
Data linkage to Medicare and SA health service utilization records.Tools:
Timepoint [6] 299160 0
At baseline, 3, 6 and 12 months.

Eligibility
Key inclusion criteria
People seen by Country MH Services who are willing to consent to be involved in the project
Receives at least one occasion of service from MH Services (assessment or case management)
Aged 18+
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intellectual disability or distress such that the study would be burdensome

Study design
Purpose
Psychosocial
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
600
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285967 0
Government body
Name [1] 285967 0
Country Health SA
Country [1] 285967 0
Australia
Primary sponsor type
Government body
Name
Country Health SA
Address
Level 12, 100 Waymouth Street, Adelaide SA 5000
Country
Australia
Secondary sponsor category [1] 284791 0
Government body
Name [1] 284791 0
Spencer Gulf Rural School
Address [1] 284791 0
Level 5 WH&HS
PO Box 267 Whyalla SA 5600
Country [1] 284791 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287999 0
Department of Health Human Research Ethics Committee
Ethics committee address [1] 287999 0
Ethics committee country [1] 287999 0
Australia
Date submitted for ethics approval [1] 287999 0
23/11/2011
Approval date [1] 287999 0
01/02/2012
Ethics approval number [1] 287999 0
487/11/2014
Ethics committee name [2] 288008 0
Medicare External Request Evaluation Committee
Ethics committee address [2] 288008 0
Ethics committee country [2] 288008 0
Australia
Date submitted for ethics approval [2] 288008 0
11/10/2011
Approval date [2] 288008 0
10/04/2012
Ethics approval number [2] 288008 0
2011/CO09766

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

Contacts
Principal investigator
Name 34686 0
Address 34686 0
Country 34686 0
Phone 34686 0
Fax 34686 0
Email 34686 0
Contact person for public queries
Name 17933 0
A/Prof Niranjan Bidargaddi
Address 17933 0
Level 12, 100 Waymouth Street, Adelaide SA 5000
Country 17933 0
Australia
Phone 17933 0
+61 8 82268107
Fax 17933 0
Email 17933 0
[email protected]
Contact person for scientific queries
Name 8861 0
Dr Niranjan Bidargaddi
Address 8861 0
Level 12, 100 Waymouth Street, Adelaide SA 5000
Country 8861 0
Australia
Phone 8861 0
+61 8 82268107
Fax 8861 0
Email 8861 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.