Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000086864
Ethics application status
Approved
Date submitted
17/01/2012
Date registered
17/01/2012
Date last updated
31/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Townsville Diabetes Home Monitoring Project
Scientific title
Among patients with poorly controlled Type II diabetes will remote access to clinical care supported by the National Broadband Network (NBN) telehealth technologies, compared with usual diabetes care lead to improved diabetes control
Secondary ID [1] 279740 0
Nil
Universal Trial Number (UTN)
U1111-1127-2155
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type II diabetes 285596 0
Condition category
Condition code
Metabolic and Endocrine 285793 285793 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is 12 months in duration. Using NBN telehealth technologies patients will receive online diabetes care from a doiabetes educator nurse (DEN) via an in-home broadband monitoring and communication device that can prompt the capture of clinical measures including: regular blood pressure monitoring (at least once a week depending on patient); regular blood glucose monitoring (at least once a week depending on patient) ; 6 monthly participation in monitored online health questionnaires to reinforce diabetes self management and assist early detection of complications; participation in clinical video conferencing sessions as required with diabetes educator nurse and GP (on a case by case basis).
Intervention code [1] 284045 0
Treatment: Devices
Intervention code [2] 284047 0
Other interventions
Intervention code [3] 284048 0
Lifestyle
Comparator / control treatment
The control group will receive usual clinical diabetic care as determined by their own GP and participate in the clincial measurement of health assessment components of the evaluation. The trial does not seek to alter the care of this group in anyway, apart from the collection of data required for comparison with the intervention group. Guidelines encourage GPs and practices to adopt a systematic approach to diabetes care.
Control group
Active

Outcomes
Primary outcome [1] 286303 0
With 210 completing participants (105 in each arm) we will be able to detect intervention effects over usual care effects of at least a 0.4% reduction in HbA1c. This will be assessed by measuring HbA1c from patients' blood analysis.
Timepoint [1] 286303 0
Baseline, 3months, 6months, 9months and 12months after intervention commencement
Secondary outcome [1] 295564 0
Improved biomedical outcomes (Cholesterol) which will be assessed by blood analysis of patients' cholesterol levels
Timepoint [1] 295564 0
Baseline and 12months after intervention
Secondary outcome [2] 295565 0
Improved biomedical outcome (Renal function) which will be assessed by measuring serum creatine/eGFR via analysis of patients' blood
Timepoint [2] 295565 0
Baseline and 12 months after intervention
Secondary outcome [3] 295566 0
Improved biomedical outcomes (blood pressure-systolic and diastolic) which will be assessed via patients' blood pressure meaurement using a blood pressure monitor
Timepoint [3] 295566 0
Baseline, 3months, 6months, 9months and 12months after intervention commencement
Secondary outcome [4] 295567 0
Improved biomedical outcomes (Weight and waist circumference). Patients' weight and waist circumference will be assesed via clinical assessment.
Timepoint [4] 295567 0
Baseline and monthly until end of intervention at 12 months
Secondary outcome [5] 295568 0
Incidence of diabetes related complications (derived from clinical record audit data)
Timepoint [5] 295568 0
12 months after intervention commencement
Secondary outcome [6] 295569 0
Quality of life measures (quality of life questionnaire; Patient assessment of chronic illness care questionnaire; clinical depression and mental health questionnaire)
Timepoint [6] 295569 0
Baseline, 6 months and 12months after intervention commencement
Secondary outcome [7] 295570 0
Improved experience of care derived from questionnaires administered to both patients and care providers
Timepoint [7] 295570 0
Baseline, 3 months, 6 months and 12months after intervention commencement
Secondary outcome [8] 295571 0
Utilisation of technology derived from questionnaires administerd to intervention patients and care givers
Timepoint [8] 295571 0
3 months, 6 months and 12months after intervention commencement
Secondary outcome [9] 295572 0
Improved service utilisation and efficiency of healthcare workforce assessed via data on health care utilisation by patients for primary care services and admissions to public hospitals. The intervention arm will also incur the costs of intervention including set up (home monitors) and operating costs (diabetes educator nurse)
Timepoint [9] 295572 0
Monthly until end of intervention at 12 months

Eligibility
Key inclusion criteria
For a patient to be included in the trial:
Have a regular GP providing primary care
The practice should have a diabetes register (using Canning data extractor tool or equivalent)
Patients should:
Be diagnosed with type 2 Diabetes (not type 1)
Live in a National Broadband Network (NBN) connected area in their home (not a residential aged care facility) & be willing to connect to NBN at no cost
Be an adult, aged 18 years or over
Have recorded a HbA1c greater than or equal to 7.5 % at any time in the previous 12 months (or if no result available, HbA1c greater than or equal to 7.5 % when tested)
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients should be excluded if they have any of the following conditions or characteristics:
Pregnancy
Cancer (except non-melanotic skin cancer) diagnosed in the previous 12 months
Palliative care
Intellectual and mental impairment (that would preclude use of technology)
Dementia (that would preclude use of technology)
Primary language other than English
Chronic kidney disease and on dialysis or likely to be on dialysis within the timeframe of the trial
Severe vision impairment (if deemed unable to use technology)
Severe unstable co-morbidities as assessed by GP as unlikely to survive for the 12 month period of the trial
Current enrolment in another health intervention trial

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)
People will be recruited based on having type 2 diabetes and living in a geographically defined area with access to the National Broadband Network. They must be under the care of a GP in the same geographic area and provide written consent to participate.
A letter will be sent by their GP advising that they are eligible for the trial. Information about the trial and phone contact details of the trial team,will be enclosed with the letter, as will a consent form. Information meetings for potential participants will also be arranged by the trial team and details included in the GP letter.
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using procedures like coin tossing and dice rolling
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
Not yet recruiting
Date of first participant enrolment
Anticipated
30/01/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
210
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 4856 0
4812
Recruitment postcode(s) [2] 4855 0
4814

Funding & Sponsors
Funding source category [1] 284523 0
Government body
Name [1] 284523 0
Department of Broadband, Communications and Digital Economy under the Digital Regions Initiatives National Partnership Agreement
Country [1] 284523 0
Australia
Funding source category [2] 284524 0
Government body
Name [2] 284524 0
Queensland Health
Country [2] 284524 0
Australia
Primary sponsor type
Other
Name
Townsville Mackay Medicare Local (TMML)
Address
UNIT 3/106 DALRYMPLE SERVICE ROAD CURRAJONG Q 4812
Country
Australia
Secondary sponsor category [1] 283450 0
None
Name [1] 283450 0
Address [1] 283450 0
Country [1] 283450 0
Other collaborator category [1] 260453 0
Individual
Name [1] 260453 0
Professor Paul Scuffham
Address [1] 260453 0
L03 2.43 School of Medicine
Logan Campus
Griffith University
Meadowbrook QLD 4131
Griffith University
Country [1] 260453 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286506 0
RACGP National Research and Evaluation Ethics Commitee
Ethics committee address [1] 286506 0
College House, 1 Palmerston Crescent, South Melbourne Vic 3205
Ethics committee country [1] 286506 0
Australia
Date submitted for ethics approval [1] 286506 0
Approval date [1] 286506 0
31/10/2011
Ethics approval number [1] 286506 0
NREEC 11-006

Summary
Brief summary
This randomised controlled trial will explore whether remote access to clinical care, supported by telehealth technologies over high speed broadband, leads to improved diabetes control in a way that benefits patients, carers and clinicians, and improves the overall health system. People with poorly controlled type 2 diabetes mellitus who reside in the suburbs connected to the national broadband network will be recruited from general practices (GP). People in the intervention arm of the trial will receive additional diabetes care from a diabetes educator nurse via an in-home broadband communication device that can capture clinical measures, provide regular health assessments and videoconference with other health professionals when required. The GPs will continue to manage their patients’ care in partnership with the diabetes educator nurse (DEN). The intervention period is 12 months. Each care plan will include frequency for remote monitoring of clinical measures and patient health assessments, and protocols for managing changes in the clinical status of the patient. The DEN will be in close communication with the GPs throughout the trial. Patients in the control arm of the trial will receive usual care from their GP and participate in the clinical measurement and quality of life components of the evaluation. On completion of the trial, the control patients will be offered remote DEN care for a three month period. The trial evaluation will include biomedical, psychological, self management and quality of life measures. Data on utilisation rates and satisfaction with the technology will be collected, and cost -effectiveness analyses undertaken. The role of this technology on health care reform will be explored.
The trial aims to answer the following specific questions about remote telehealth monitoring:
Does it improve health outcomes?
Does it improve the experience of care for patients , their carers and clinicians?
Does it improve primary care capacity and integration of care?
Does it improve service utilisation and efficiency of the healthcare workforce?
How well does it utilize the high speed broadband network?
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33639 0
Address 33639 0
Country 33639 0
Phone 33639 0
Fax 33639 0
Email 33639 0
Contact person for public queries
Name 16886 0
Robin Warren
Address 16886 0
Unit 3/106 Dalrymple Service Road Currajong QLD 4812, PO Box 7780 Garbutt BC QLD 4814
Country 16886 0
Australia
Phone 16886 0
+61 7 4725 8915
Fax 16886 0
+61 7 4725 8921
Email 16886 0
rwarren@tmml.com.au
Contact person for scientific queries
Name 7814 0
Robin Warren
Address 7814 0
Unit 3/106 Dalrymple Service Road Currajong QLD 4812, PO Box 7780 Garbutt BC QLD 4814
Country 7814 0
Australia
Phone 7814 0
+61 7 4725 8915
Fax 7814 0
+61 7 4725 8921
Email 7814 0
rwarren@tmml.com.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
No additional documents have been identified.