ANZCTR - Registration

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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]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Diabetes

Chronic Obstructive Pulmonary Disease

Renal Disease

Hypertension

Coronary Heart Disease

Condition category

Condition code

Cardiovascular

Coronary heart disease

Diet and Nutrition

Obesity

Metabolic and Endocrine

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]

Other interventions

Intervention code [2]

Lifestyle

Intervention code [3]

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]

Primary Outcome 1: reduction in glycated haemoglobin (HbA1c) among adults with diabetes, assessed through blood analysis.

Timepoint [1]

Baseline and 18 months

Secondary outcome [1]

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]

12 months after commencement of intervention and 24 months

Secondary outcome [2]

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]

12 months after commencement of intervention and 24 months

Secondary outcome [3]

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]

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?

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]

4876

Recruitment postcode(s) [2]

4875

Recruitment postcode(s) [3]

4874

Recruitment postcode(s) [4]

4871

Recruitment postcode(s) [5]

4873

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

National Health and Medical Research Council

Address [1]

GPO Box 1421
Canberra ACT 2601

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

Queensland Health

Address [2]

147-163 Charlotte Street
Brisbane Qld 4000

Country [2]

Australia

Primary sponsor type

Government body

Name

Queensland Health

Address

147-163 Charlotte Street
Brisbane Qld 4000

Country

Australia

Secondary sponsor category [1]

Other Collaborative groups

Name [1]

Apunipima Cape York Health Council

Address [1]

186 McCoombe Street
Bungalow Qld 4870

Country [1]

Australia

Secondary sponsor category [2]

University

Name [2]

University of Queensland

Address [2]

Research and Innovation Division
Cumbrae Stewart Building
Brisbane Qld 4072

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Cairns Base Health Service District Human Research Ethics Committee

Ethics committee address [1]

PO Box 902
Cairns Qld 4870

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

28/04/2010

Ethics approval number [1]

HREC/10/QCH/30-654

Ethics committee name [2]

University of Queensland, Medical Research Ethics Committee

Ethics committee address [2]

Research and Innovation Division
Cumbrae Stewart Building
Brisbane Qld 4072

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

Approval date [2]

10/08/2010

Ethics approval number [2]

2010001007

Ethics committee name [3]

University of South Australia Human Research Ethics Committee

Ethics committee address [3]

GPO Box 2471
Adelaide SA 5001

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

Approval date [3]

10/09/2010

Ethics approval number [3]

P091/10

Summary

Brief summary

The life expectancy gap for Indigenous people in Australia is 13 years and most of this gap is due to preventable chronic disease (diabetes, heart, lung and renal problems) in adults. Once people have these conditions, many complications can be prevented with good primary-level chronic care.  This project aims to introduce and evaluate a new strategy for integrated community-based, intensive chronic condition management in rural and remote Indigenous primary care services:  Diabetes, hypertension, coronary heart disease (CHD), renal disease and chronic obstructive pulmonary disease (COPD).

Proposed strategy: An intervention in 3 phases over 5 years:

1.  A trial of intensive locally delivered chronic care in 6 out of 12 participating sites in FNQ with clear clinical and quality-of-life outcomes;
2.  Review of lessons learned in the first phase trial, modified as necessary to reflect findings, a discussion about generalisability to the “control” sites in the trial, with an implementation plan and the development of a curriculum package for the program and;
3.  In collaboration with the trial partners(QH, Apunipima CYHC and local AMS where relevant), a more general system rollout of lessons learned, with potential regional implications of a patient-centred service delivery model, including workforce and funding applications.

Trial website

None

Trial related presentations / publications

Publications
1. Schmidt B, Wenitong M, Esterman A, Hoy W, Segal L, Taylor S, et al. Getting better at chronic care in remote communities: study protocol for a pragmatic cluster randomised controlled of community based management. BMC Public Health. 2012;12(1):1017. 

2.Johnson J, McDermott R, Clifton P, D’Onise K, Taylor S, Preece C, et al. Characteristics of Indigenous adults with poorly controlled diabetes in north Queensland: implications for services. . BMC Public Health. 2015.

3. McDermott R, Schmidt B, Preece C, Owens  V, Taylor  S, Li M, et al. Community health workers improve diabetes care in remote Australian Indigenous communities: results of a pragmatic cluster randomized controlled trial. BMC Health Serv Res. 2015;15(68).

4. Schmidt B, Campbell S, McDermott R. Community health workers as chronic care coordinators: evaluation of an Australian Indigenous primary health care program. Australian and New Zealand Journal of Public Health. 2015:n/a-n/a.

5. McDermott R, Schmidt B, Wenitong M, Sinha A, Hoy W, Owens V, et al. Do Indigenous Health Workers improve chronic care for high risk adults in remote communities: lessons from a cluster randomised and implications for service delivery. Australian Diabetes Educator. 2015;18(3).

Poster presentations
2013 	PHCRIS Conference
Integrated community based/family-centred management of chronic conditions by Indigenous Health Workers for Indigenous clients in rural and remote Queensland: a cluster randomised controlled trial

2014	NT Chronic Disease conference
Getting Better at Chronic Care in North Queensland: Improving Health literacy for high risk Aboriginal and Torres Strait clients: the answer is in the community

2014       AITHM Conference Cairns
Improving health literacy for high risk Aboriginal and Torres Strait Islander clients: The answer is in the community. 

2015	PHCRIS Conference
Community Health Workers reduce avoidable acute hospitalisations for diabetes: a cluster randomised trial in far north Queensland Indigenous communities

2015	PHCRIS conference
Getting Better at Chronic Care in North Queensland Measuring implementation fidelity: Assessment of a chronic disease case management model delivered by Indigenous Health Workers in remote communities

Conference presentations
2013  PHA - Social determinants of Health - Canberra - Barbara Schmidt & Frank Hollingsworth:  Chronic Care Coordination by Indigenous Health Workers – A solution for better care?

2014  PHCRIS conference - Canberra - Dr Robyn McDermott: Getting Better at Chronic Care (GBACC) in North Queensland: a cluster RCT of community health worker care co-ordination in remote FNQ settings

2014  PHCRIS conference - Barbara Schmidt: Community Health Workers as chronic care coordinators: A mixed methods evaluation of Indigenous primary health care services in far north Queensland

2015 AITHM Conference, Cairns - Barbara Schmidt-Improving health literacy for high risk Aboriginal and Torres Strait Islander clients: The answer is in the community. 

2015 Queensland Health Chronic Disease conference - Dr Robyn McDermott

Public notes

Attachments [1]

/AnzctrAttachments/336002-Getting better at chronic care in north queensland.pdf

Attachments [2]

/AnzctrAttachments/336002-Do Indigenous Health Workers Improve Chronic Care for High Risk Adults in Remote Communities.pdf

Attachments [3]

/AnzctrAttachments/336002-Johnson 2015 BMC.pdf

Attachments [4]

/AnzctrAttachments/336002-Schmidt_et_al-Australian_and_New_Zealand_Journal_of_Public_Health.pdf

Contacts

Principal investigator

Name

Prof Robyn McDermott

Address

University of South Australia CEA-01, GPO Box 2471 Adelaide SA 5001

Country

Australia

Phone

+61 8 8302 2922

Fax

robyn.mcdermott@unisa.edu.au

Contact person for public queries

Name

Robyn McDermott

Address

University of South Australia
CEA-01, GPO Box 2471
Adelaide SA 5001

Country

Australia

Phone

+61 8 8302 2922

Fax

+61 8 8302 2794

robyn.mcdermott@unisa.edu.au

Contact person for scientific queries

Name

Robyn McDermott

Address

University of South Australia
CEA-01, GPO Box 2471
Adelaide SA 5001

Country

Australia

Phone

+61 8 8302 2922

Fax

+61 8 8302 2794

robyn.mcdermott@unisa.edu.au

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

Source	Title	Year of Publication	DOI
Embase	Community health workers improve diabetes care in remote Australian Indigenous communities: results of a pragmatic cluster randomized controlled trial.	2015	https://dx.doi.org/10.1186/s12913-015-0695-5
Embase	Economic evaluation of indigenous health worker management of poorly controlled type 2 diabetes in north Queensland.	2016	https://dx.doi.org/10.5694/mja15.00598

N.B. These documents automatically identified may not have been verified by the study sponsor.

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Documents added manually

Documents added automatically