Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000812099
Ethics application status
Approved
Date submitted
22/09/2010
Date registered
29/09/2010
Date last updated
25/02/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Getting better at chronic care in North Queensland: A cluster randomized trial of patient-centred care delivered by Indigenous health professionals to Indigenous clients.
Scientific title
Getting better at chronic care in North Queensland: A cluster randomized trial of patient-centred care delivered by Indigenous health professionals to Indigenous clients.
Secondary ID [1] 252743 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 258241 0
Chronic Obstructive Pulmonary Disease 258242 0
Renal Disease 258243 0
Hypertension 258244 0
Coronary Heart Disease 258245 0
Condition category
Condition code
Cardiovascular 258420 258420 0 0
Coronary heart disease
Diet and Nutrition 258421 258421 0 0
Obesity
Metabolic and Endocrine 258422 258422 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nutrition, lifestyle support, drug management, physical activity support to participants, workshops and focus groups for participants, care planning with each participant. The intervention will involve treatment intensification including with insulin, nutrition coaching with families, and upskilling of health workers in clinical management. The frequency and duration of these sessions will be tailored to the needs of the community and the participants. This will include engaging with families to discuss nutrition, lifestyle support, smoking cessation and physical exercise, self-monitoring of conditions, and appropriate drug management, and using local resources to support effective client self-management. The unit of intervention is the COMMUNITY, via a designated specialist health worker. This means that out of the 12 participating communities, 6 communities will be randomly selected to undertake the intervention in the first 2 years. The remaining 6 communities (the control communities) will not take part in the intervention. Control communities will participate in the intervention in year 3 of the study with one IHW FTE will be recruited for each intervention site, who is eligible at HW Level 004. An Indigenous clinical support team (ICST) will train and mentor community-based IHWs (and the rest of the PHC team) to deliver intensive management for 5 common chronic conditions, with clear clinical and service goals.
Intervention code [1] 257258 0
Other interventions
Intervention code [2] 257259 0
Lifestyle
Intervention code [3] 257260 0
Behaviour
Comparator / control treatment
Control communities receive ‘usual care’ during the intervention phase. They will receive a similar intervention, informed by the trial results and agreed upon by partner organisations, in year 4.
Control group
Active

Outcomes
Primary outcome [1] 259270 0
Primary Outcome 1: reduction in glycated haemoglobin (HbA1c) among adults with diabetes, assessed through blood analysis.
Timepoint [1] 259270 0
Baseline and 18 months
Secondary outcome [1] 265676 0
Secondary Outcome 1: Clinic care processes are improved.

Assessment of this outcome will include checking of weight, waist circumference, HbA1c, blood pressure (BP), lipids, urinary albumin creatinine ratio (UACR) according to care plans (6 monthly and annually) plus vaccinations.
Timepoint [1] 265676 0
12 months after commencement of intervention and 24 months
Secondary outcome [2] 265677 0
Secondary Outcome 2: Intermediate condition specific outcomes (other than HbA1c) eg blood pressure control, avoidable hospitalisations.

Assessment of this outcome will include tests of HbA1c, 6 monthly, and blood pressure six monthly. Hospitalisations 12 monthly.
Timepoint [2] 265677 0
12 months after commencement of intervention and 24 months
Secondary outcome [3] 265678 0
Secondary Outcome 3: Changes in client Quality of Life indicators and service satisfaction from baseline.

Assessment of this outcome will be through the administration of questionnaires such as; assessment of quality of life questionnaires (AQoL) and the SF-36, a health survey questionnaire.
Timepoint [3] 265678 0
12 months after commencement of intervention and 24 months

Eligibility
Key inclusion criteria
Indigenous patients from clinics in rural north Queensland, in the communities listed below, diagnosed at least one year prior to recruitment with diabetes (with HbA1c> 8.5%) and at least one of the four following conditions:

1. Chronic obstructive pulmonary disease
2. Renal disease
3. Hypertension
4. Coronary heart disease.
Communities in rural north Queensland: Bamaga Umagico Seisia New Mapoon Injinoo Badu Island Napranum Old Mapoon Kowanyama Mossman Gorge Yarrabah Mareeba
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Over 65 years of age
Major mental illness
Chronic Renal Failure Stages 4 & 5
Pregnancy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Enrolment is by the health service from the diabetes register. Randomisation is by community. Allocation is concealed because clusters are randomly selected to the intervention group after enrolment of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation. All 12 community (cluster) names are placed into a hat, and the first 6 names removed from the hat receive the intervention.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
This is a cluster trial.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2010
Actual
10/12/2010
Date of last participant enrolment
Anticipated
Actual
11/07/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
360
Accrual to date
Final
213
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment postcode(s) [1] 3283 0
4876
Recruitment postcode(s) [2] 3284 0
4875
Recruitment postcode(s) [3] 3285 0
4874
Recruitment postcode(s) [4] 3286 0
4871
Recruitment postcode(s) [5] 3287 0
4873

Funding & Sponsors
Funding source category [1] 257703 0
Government body
Name [1] 257703 0
National Health and Medical Research Council
Country [1] 257703 0
Australia
Funding source category [2] 257704 0
Government body
Name [2] 257704 0
Queensland Health
Country [2] 257704 0
Australia
Primary sponsor type
Government body
Name
Queensland Health
Address
147-163 Charlotte Street
Brisbane Qld 4000
Country
Australia
Secondary sponsor category [1] 256917 0
Other Collaborative groups
Name [1] 256917 0
Apunipima Cape York Health Council
Address [1] 256917 0
186 McCoombe Street
Bungalow Qld 4870
Country [1] 256917 0
Australia
Secondary sponsor category [2] 256918 0
University
Name [2] 256918 0
University of Queensland
Address [2] 256918 0
Research and Innovation Division
Cumbrae Stewart Building
Brisbane Qld 4072
Country [2] 256918 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259733 0
Cairns Base Health Service District Human Research Ethics Committee
Ethics committee address [1] 259733 0
Ethics committee country [1] 259733 0
Australia
Date submitted for ethics approval [1] 259733 0
Approval date [1] 259733 0
28/04/2010
Ethics approval number [1] 259733 0
HREC/10/QCH/30-654
Ethics committee name [2] 259734 0
University of Queensland, Medical Research Ethics Committee
Ethics committee address [2] 259734 0
Ethics committee country [2] 259734 0
Australia
Date submitted for ethics approval [2] 259734 0
Approval date [2] 259734 0
10/08/2010
Ethics approval number [2] 259734 0
2010001007
Ethics committee name [3] 259735 0
University of South Australia Human Research Ethics Committee
Ethics committee address [3] 259735 0
Ethics committee country [3] 259735 0
Australia
Date submitted for ethics approval [3] 259735 0
Approval date [3] 259735 0
10/09/2010
Ethics approval number [3] 259735 0
P091/10

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 778 778 0 0
/AnzctrAttachments/336002-Getting better at chronic care in north queensland.pdf
Attachments [2] 779 779 0 0
/AnzctrAttachments/336002-Do Indigenous Health Workers Improve Chronic Care for High Risk Adults in Remote Communities.pdf
Attachments [3] 780 780 0 0
/AnzctrAttachments/336002-Johnson 2015 BMC.pdf
Attachments [4] 781 781 0 0
/AnzctrAttachments/336002-Schmidt_et_al-Australian_and_New_Zealand_Journal_of_Public_Health.pdf

Contacts
Principal investigator
Name 31680 0
Prof Robyn McDermott
Address 31680 0
University of South Australia CEA-01, GPO Box 2471 Adelaide SA 5001
Country 31680 0
Australia
Phone 31680 0
+61 8 8302 2922
Fax 31680 0
Email 31680 0
[email protected]
Contact person for public queries
Name 14927 0
Robyn McDermott
Address 14927 0
University of South Australia
CEA-01, GPO Box 2471
Adelaide SA 5001
Country 14927 0
Australia
Phone 14927 0
+61 8 8302 2922
Fax 14927 0
+61 8 8302 2794
Email 14927 0
[email protected]
Contact person for scientific queries
Name 5855 0
Robyn McDermott
Address 5855 0
University of South Australia
CEA-01, GPO Box 2471
Adelaide SA 5001
Country 5855 0
Australia
Phone 5855 0
+61 8 8302 2922
Fax 5855 0
+61 8 8302 2794
Email 5855 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
SourceTitleYear of PublicationDOI
EmbaseCommunity health workers improve diabetes care in remote Australian Indigenous communities: results of a pragmatic cluster randomized controlled trial.2015https://dx.doi.org/10.1186/s12913-015-0695-5
EmbaseEconomic evaluation of indigenous health worker management of poorly controlled type 2 diabetes in north Queensland.2016https://dx.doi.org/10.5694/mja15.00598
N.B. These documents automatically identified may not have been verified by the study sponsor.