Trial Review

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
ACTRN12611000518965
Ethics application status
Approved
Date submitted
18/05/2011
Date registered
19/05/2011
Date last updated
19/05/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Achieving Diabetes Action and Collaborative Change - A cluster RCT in Aboriginal Health
Scientific title
In Aboriginal and Torres Strait Islander Peoples can a Aboriginal Primary Health Service collaborative intervention increase screening and management of type 2 diabetes when compared with usual care
Secondary ID [1] 262194 0
Nil
Universal Trial Number (UTN)
U1111-1121-4826
Trial acronym
ADACC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 265874 0
Condition category
Condition code
Public Health 266032 266032 0 0
Health promotion/education
Metabolic and Endocrine 268042 268042 0 0
Diabetes
Public Health 268043 268043 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Aboriginal Community Control Health Organisations (ACCHOs) in the intervention arm will receive a multifactorial, ecologically based collaborative intervention for 24 months. Strategies, including recall registers and reminders, access to specialist advice, and staff training, will be included within a broader ecological approach which will identify and address barriers to change. Representative from each ACCHO will meet with researchers to review data related to screening and managment of Type 2 diabetes, explore the evidence practice gap and discuss potential solutions. Workshops at ACCHOs and inter-organisation meetings will be held throughout the intervention to provide educational material, staff training, and information on effective recall and reminder systems. ACCHOs will be able to access a website that will contain latest information on diabetes care, information tailored for each ACCHO, guidelines and clinical care prompts. Each ACCHO will set short-term and long-term clinical targets. There will be on-going feedback of clinical data to ACCHOs and access to an expert advisory group to help develop systems to providing best practice diabetes care.
Intervention code [1] 264586 0
Early detection / Screening
Intervention code [2] 264587 0
Treatment: Other
Comparator / control treatment
ACCHOs in the control group will not be provided with feedback data or assistance from the research team. Their patients will receive the usual care during the intervention and assessment period. If the outcome analysis indicates there has been a significant positive effect on screening and managment of type 2 diabetes in intervention ACCHOs then the control group will be offered the intervention.
Control group
Active

Outcomes
Primary outcome [1] 266759 0
At post test census, for patients aged 35 years and over who have attended in the previous 12 months there
will be a 10% difference between patients from experimental versus control ACCHOs in terms of the
proportion of:
1. Patients without a previous diagnosis of diabetes who have been screened for diabetes via a fasting or
random plasma glucose test within the recommended 3 year period.
Timepoint [1] 266759 0
2 years after randomisation
Primary outcome [2] 266760 0
At post test census, for patients aged 35 years and over who have attended in the previous 12 months there
will be a 10% difference between patients from experimental versus control ACCHOs in terms of the
proportion of:
2. Patients with diagnosed type 2 diabetes who have had recommended monitoring for diabetes (HbA1c and
blood lipids test) within the last 12 months.
Timepoint [2] 266760 0
2 years after randomisation
Primary outcome [3] 266761 0
At post test census, for patients aged 35 years and over who have attended in the previous 12 months there
will be a 10% difference between patients from experimental versus control ACCHOs in terms of the
proportion of:

3. Patients with diagnosed type 2 diabetes who have had HbA1c and blood lipids measured in the prior 12
months exhibiting appropriate indicators of control: ie HbA1c <7%, LDL cholesterol <2.5 mmol/l and
triglycerides<2.3 mmol/l
Timepoint [3] 266761 0
2 years after randomisation
Secondary outcome [1] 276368 0
Nil
Timepoint [1] 276368 0
Nil

Eligibility
Key inclusion criteria
Patients from Aboriginal Community Controlled Health Organisations who have at least one fulltime general practitioner.
Minimum age
35 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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)
Randomised by university staff not connected to project
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Coin toss
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
16/04/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 267082 0
Government body
Name [1] 267082 0
National Health and Medical Research Council
Country [1] 267082 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Baker IDI Heart and Diabetes Institute
Address
Baker IDI Heart and Diabetes Institute
PO Box 6492, St Kilda Road Central
Victoria 8008, Australia
Country
Australia
Secondary sponsor category [1] 264171 0
University
Name [1] 264171 0
University of Newcastle
Address [1] 264171 0
University Drive
Callaghan NSW 2308
Australia
Country [1] 264171 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 267062 0
The Alfred Human Research Ethics Committee
Ethics committee address [1] 267062 0
Ethics Office
Ground Floor Linay Pavilion
The Alfred
P.O Box 315
Prahran. Vic. 3181
Ethics committee country [1] 267062 0
Australia
Date submitted for ethics approval [1] 267062 0
21/06/2010
Approval date [1] 267062 0
21/12/2010
Ethics approval number [1] 267062 0
72/10
Ethics committee name [2] 267073 0
University of Newcastle Human Research Ethics Committee
Ethics committee address [2] 267073 0
Research Services
Research Office
The University of Newcastle
University Drive
Callaghan NSW 2308
Ethics committee country [2] 267073 0
Australia
Date submitted for ethics approval [2] 267073 0
31/01/2011
Approval date [2] 267073 0
16/02/2011
Ethics approval number [2] 267073 0
H-2011-0018
Ethics committee name [3] 267074 0
Western Australian Aboriginal Health Information and Ethics Committee (WAAHIEC)
Ethics committee address [3] 267074 0
WAAHIEC Secretariat
Aboriginal Health Council of Western Australia
2 Bulwer Street
Perth WA 6000
Ethics committee country [3] 267074 0
Australia
Date submitted for ethics approval [3] 267074 0
26/11/2010
Approval date [3] 267074 0
26/04/2011
Ethics approval number [3] 267074 0
10/11/0331

Summary
Brief summary
ACCHOs have an important role to play in reducing the impact of diabetes on Indigenous people. This study aims to trial a strategy for helping ACCHOs improve screening for diabetes and diabetes care. Existing data such as rates of HbA1c testing and outcomes of these tests will be used to assess whether the strategy is successful
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32613 0
Address 32613 0
Country 32613 0
Phone 32613 0
Fax 32613 0
Email 32613 0
Contact person for public queries
Name 15860 0
Professor Sandra Eades
Address 15860 0
Prof Sandra Eades
Associate Director Preventive Health
Baker IDI Heart and Diabetes Institute
PO Box 6492
St Kilda Rd Central
Melbourne VIC 8008
Country 15860 0
Australia
Phone 15860 0
+61 3 85321535
Fax 15860 0
+61 3 85351100
Email 15860 0
[email protected]
Contact person for scientific queries
Name 6788 0
Dr Chris Paul
Address 6788 0
Room 268
David Maddison Building
Cnr King & Watt Sts
Newcastle NSW 2300
The University of Newcastle
AUSTRALIA
Country 6788 0
Australia
Phone 6788 0
+61 2 49138472
Fax 6788 0
+61 2 49138779
Email 6788 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.