Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000380897
Ethics application status
Approved
Date submitted
2/04/2012
Date registered
3/04/2012
Date last updated
19/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised trial of a novel model of diabetes care for adults in the community through multidisciplinary collaboration and integration across the primary and tertiary interface
Scientific title
Comparison of a novel model of community care versus usual care on glycaemic control in adults with type 2 diabetes: a randomised trial
Secondary ID [1] 280100 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 diabetes 286013 0
Condition category
Condition code
Metabolic and Endocrine 286201 286201 0 0
Diabetes
Public Health 286431 286431 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This intervention is based on a novel concept which incorporates the principle of General Practitioners (GPs) with special interests around a multidisciplinary and coordinated approach to diabetes care in the community. This model of care includes a specialist doctor (endocrinologist), who acts in a consulting capacity to the GP, to endorse the GPs patient management plan. The intervention is delivered face to face with their advanced GP as well as with a diabetes nurse educator. This intervention will include follow up appointments which will be approximately every 6 weeks and will continue until 12 months.
Intervention code [1] 284425 0
Treatment: Other
Comparator / control treatment
Usual care for patients with complex type 2 diabetes is in an endocrinology and diabetes outpatients settings at a secondary or tertiary hospital. Typically patient care is delivered prodominantly by a consultant doctor (an endocrinologist).
Control group
Active

Outcomes
Primary outcome [1] 286675 0
glycaemic control (as measured by HbA1c)
Timepoint [1] 286675 0
6 months
12 months
Secondary outcome [1] 296480 0
blood pressure
Timepoint [1] 296480 0
6 months
12 months
Secondary outcome [2] 296885 0
cholesterol and cholesterol fractions
Timepoint [2] 296885 0
6 months
12 months
Secondary outcome [3] 296886 0
Body mass index
Timepoint [3] 296886 0
6 months
12 months
Secondary outcome [4] 296887 0
proportion of patients ceased smoking, collected by patient self-report on questionnaire
Timepoint [4] 296887 0
6 months
12 months
Secondary outcome [5] 296888 0
foot complications including presence of diabetic ulcers/sores, partial or total foot amputation, charcot joint, delayed healing times for injured skin, neuropathic symptoms, pulses present in right and left foot (determined by assessment from podiatrist)
Timepoint [5] 296888 0
6 months
12 months
Secondary outcome [6] 296889 0
retinopathy complications (determined by patient medical records data)
Timepoint [6] 296889 0
6 months
12 months
Secondary outcome [7] 296890 0
microalbuminuria (determined by urine analysis to calculate albumuria to creatinine ratio and compared to reference range)
Timepoint [7] 296890 0
6 months
12 months
Secondary outcome [8] 296891 0
serum creatinine
Timepoint [8] 296891 0
6 months
12 months
Secondary outcome [9] 296892 0
hospitalisations for diabetic related complications (determined by data linkage to external database Queensland Hospital Admitted Patients Data Collection (QHAPDC))
Timepoint [9] 296892 0
6 months
12 months
Secondary outcome [10] 296893 0
proportion of patients achieving clinical target for HbA1c (at less than or equal to 7%) measured by blood pathology testing
Timepoint [10] 296893 0
6 months
12 months
Secondary outcome [11] 296894 0
proportion of patients achieving clinical target for blood pressure (at less than or equal to 130/80 mm/Hg) measured in seated position with digital sphygmomanometer
Timepoint [11] 296894 0
6 months
12 months
Secondary outcome [12] 296895 0
proportion of patients achieving clinical target for low density lipoprotein (at less than or equal to 2.5 mmol/L) measured by blood pathology testing
Timepoint [12] 296895 0
6 months
12 months

Eligibility
Key inclusion criteria
greater than 18 years
type 2 diabetes
referred to secondary/tertiary hospital diabetes outpatients for care
residing in the geographical area of interest in Brisbane, Australia
able to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
patients without hypoglycaemic awareness
pregnancy
receiving haemodialysis
patients with terminal illness with life expectancy less than 2 years

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)
The person who determines if a patient is eligible to participate is unaware of the allocation group at the time of enrolment. Randomisation to group is conducted after eligibility is confirmed and consent has been provided from the patient.

Allocation to treatment group is done off site by the study statistician who is removed from the screening of participants.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will use a weighted control of 3 intervention to 1 control. The randomisation will be done via web based computer randomisation, which is set up by the study statistician remotely.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
multi site
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2012
Actual
27/11/2012
Date of last participant enrolment
Anticipated
Actual
14/07/2015
Date of last data collection
Anticipated
Actual
31/12/2016
Sample size
Target
400
Accrual to date
Final
352
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 284856 0
Government body
Name [1] 284856 0
National Health and Medical Research Council
Country [1] 284856 0
Australia
Primary sponsor type
Individual
Name
Professor Claire Jackson
Address
Discipline of General Practice
School of Medicine
The University of Queensland
Level 8, Health Science Building
Royal Brisbane and Women's Hospital
Herston QLD 4029
Country
Australia
Secondary sponsor category [1] 283735 0
Individual
Name [1] 283735 0
Associate Professor Anthony Russell
Address [1] 283735 0
Department of Diabetes and Endocrinology
Princess Alexandra Hospital
199 Ipswich Road
Woolloongabba QLD 4102
Country [1] 283735 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287033 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 287033 0
Ethics committee country [1] 287033 0
Date submitted for ethics approval [1] 287033 0
12/04/2012
Approval date [1] 287033 0
31/05/2012
Ethics approval number [1] 287033 0

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

Contacts
Principal investigator
Name 33884 0
Prof Claire Jackson
Address 33884 0
Discipline of General Practice The School of Medicine The University of Queensland Level8, Health Sciences Building Royal Brisbane and Women's Hospital Herston 4029 QLD
Country 33884 0
Australia
Phone 33884 0
+61 7 3365 5381
Fax 33884 0
Email 33884 0
[email protected]
Contact person for public queries
Name 17131 0
Dr Maria Donald
Address 17131 0
Discipline of General Practice
The School of Medicine
The University of Queensland
Level8, Health Sciences Building
Royal Brisbane and Women's Hospital
Herston 4029 QLD
Country 17131 0
Australia
Phone 17131 0
+61 7 3346 5135
Fax 17131 0
+61 7 3346 5178
Email 17131 0
[email protected]
Contact person for scientific queries
Name 8059 0
Professor Claire Jackson
Address 8059 0
Discipline of General Practice
The School of Medicine
The University of Queensland
Level8, Health Sciences Building
Royal Brisbane and Women's Hospital
Herston 4029 QLD
Country 8059 0
Australia
Phone 8059 0
+61 7 3365 5381
Fax 8059 0
+61 7 3346 5178
Email 8059 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
EmbaseClinical outcomes of an integrated primary-secondary model of care for individuals with complex type 2 diabetes: a non-inferiority randomised controlled trial.2019https://dx.doi.org/10.1007/s00125-018-4740-x
N.B. These documents automatically identified may not have been verified by the study sponsor.