Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000370404
Ethics application status
Approved
Date submitted
15/03/2016
Date registered
22/03/2016
Date last updated
24/02/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The evaluation of telehealth technologies to facilitate clinical outcomes improvements in eye care, diabetes and cardiovascular disease management for Indigenous Australians.
Scientific title
An Evaluation of Telehealth in the Facilitation of Diabetes and Cardiovascular Care for improving disease management in three Aboriginal-Controlled Community Health Organisations in the Northern Territory, Australia
Secondary ID [1] 288714 0
Nil
Universal Trial Number (UTN)
Trial acronym
TEAMSnet (Telehealth Eye and Associated Medical Services network)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 297942 0
Cardiovascular 297943 0
Diabetic retinopathy 297944 0
Condition category
Condition code
Cardiovascular 298106 298106 0 0
Hypertension
Eye 298107 298107 0 0
Diseases / disorders of the eye
Metabolic and Endocrine 298209 298209 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Telehealth technology is implemented in a primary care environment to facilitate delivery of eye care and diabetes and cardiovascular health services. Three separate technologies will be used as follows:
1. Use of non-mydriatic retinal fundus cameras to acquire retinal images in the primary care environment. The retinal images are transmitted to a central site (Centre for Eye Research Australia) for retinopathy assessment. The resultant retinopathy reports are transmitted back to the originating site for subsequent eye care management. Patients are encouraged to view their own retinal images and discuss diabetes and eye care with the on-site retinal imager.
2. We will develop a software application, interfaced to Communicare, the Electronic Health Record (EHR) system, to provide cardiovascular risk assessment, and diabetes and cardiovascular electronic decision support based on current laboratory values, medications and conditions. The medical data required to generate the risk calculation and electronic decision support (EDS) is electronically pulled from the Communicare EHR system. The results of the EDS is a series of recommendations based on the Central Australian Rural Practitioners Association (CARPA) clinical guidelines.
3. We will develop a mobile tablet application, primarily for use by Aboriginal Health Workers to support lifestyle decision support and self-management coaching in diabetes and heart disease.
The retinal imaging will be performed annually as required by usual care. The software EDS module will be used by the GP as part of their regularly scheduled clinic visit with the patient. The mobile tablet application is primarily envisioned to be used by the nurse or Aboriginal Health Worker in the clinic waiting room while the patient is waiting to see their doctor.
The retinal imaging will be performed by trained retinal imagers under the supervision of the clinic GPs and will be an adjunct to the regular visiting optometry programme. The GP will use the Electronic Decision Support software application. The clinic, nurse, diabetes educator or Aboriginal Health Worker will use the mobile tablet application under the supervision of the GP.
The mobile tablet application has the capability of archiving educational material. The educational material is the standard educational material used by the clinic for their patients but converted to electronic files so that they can be delivered using the mobile tablet application.
All the clinical decision support and lifestyle support are derived from the Central Australia Rural Practitioners Association (CARPA) Standard Treatment Manual (Version 6) which has a specific focus on the unique requirements of Indigenous health service provision.
Intervention code [1] 294186 0
Treatment: Other
Comparator / control treatment
No Control Group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297657 0
Adherence to scheduled eye care referrals and scheduled clinic visits. I
Timepoint [1] 297657 0
Two years post implementation of the eye care telehealth intervention and 1 year post implementation of the Electronic Decision Support and mobile tablet Lifestyle support applications.
Secondary outcome [1] 321730 0
Blood Glucose control derived from standard care laboratory Haemoglobin A1c values
Timepoint [1] 321730 0
1 year post electronic decision support implementation
Secondary outcome [2] 322023 0
Blood pressure obtained from regularly schedule clinic visits
Timepoint [2] 322023 0
1 year post electronic decision support implemenation
Secondary outcome [3] 322024 0
Lipid levels derived from standard care laboratory values
Timepoint [3] 322024 0
1 year post electronic decision support implementation

Eligibility
Key inclusion criteria
Over the age of 18 years
Confirmed clinical diagnosis of type 1 or type 2 diabetes mellitus at least 6 months prior to consent
Willingness to sit through a retinal imaging session
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Under the age of 18
History of laser photocoagulation
Current vitreous bleeding or haemorrhage
Inability to obtain adequate retinal images (as assessed by the study retinal imager due to media opacity (cataract) or if the patient is unable to have the imaging assessments performed or is unable to engage in the proposed follow up schedule

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis
The sample size calculation was powered on adherence to subsequent scheduled eye examinations
For a conservative adherence differential to subsequent eye care of 15%, with 80% power, the minimum sample size was determined to be 490 patients. ,
Given attrition and drop out, a recruitment goal for 600 patients was set

Descriptive statistics, univariate and multivariate analyses [regression and principal component analyses] of descriptive data for CVD and diabetes risk factors, diabetic retinopathy and clinical encounters in the pre-post study setting. Quantitative evaluation of survey data for lifestyle risk factors [smoking, nutrition, alcohol, physical activity and emotional wellbeing. Qualitative evaluation of development and implementation of technologies for retinopathy screening, CVD risk assessment, analysis and decision support, electronic lifestyle surveys, and mobile tablet as a clinical and patient education tool.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
26/11/2013
Date of last participant enrolment
Anticipated
31/12/2015
Actual
31/12/2015
Date of last data collection
Anticipated
Actual
30/06/2016
Sample size
Target
600
Accrual to date
Final
600
Recruitment in Australia
Recruitment state(s)
NT
Recruitment postcode(s) [1] 12931 0
0871 - Alice Springs
Recruitment postcode(s) [2] 12932 0
0851 - Katherine
Recruitment postcode(s) [3] 12933 0
0880 - Gove

Funding & Sponsors
Funding source category [1] 293104 0
Government body
Name [1] 293104 0
National Health and Medical Research Council
Country [1] 293104 0
Australia
Funding source category [2] 293129 0
Charities/Societies/Foundations
Name [2] 293129 0
The Fred Hollows Foundation
Country [2] 293129 0
Australia
Primary sponsor type
University
Name
University of Sydney, NHMRC Clinical Trials Centre
Address
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 291894 0
Charities/Societies/Foundations
Name [1] 291894 0
The Fred Hollows Foundation
Address [1] 291894 0
Locked Bag 5021
Alexandria NSW 2015
Country [1] 291894 0
Australia
Other collaborator category [1] 278887 0
University
Name [1] 278887 0
University of Melbourne
Address [1] 278887 0
Parkville
VIC 3010
Country [1] 278887 0
Australia
Other collaborator category [2] 278888 0
Other Collaborative groups
Name [2] 278888 0
Aboriginal Medical Services Alliance Northern Territory
Address [2] 278888 0
GPO Box 1624
Darwin NT 0801
Country [2] 278888 0
Australia
Other collaborator category [3] 278889 0
Other
Name [3] 278889 0
South Australia Health and Medical Research Institute
Address [3] 278889 0
North Terrace
Adelaide SA 5000
Country [3] 278889 0
Australia
Other collaborator category [4] 278891 0
University
Name [4] 278891 0
The University of Sydney
Address [4] 278891 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [4] 278891 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294628 0
Central Australian Human Research Ethics Committee
Ethics committee address [1] 294628 0
PO Box 4066
Alice Springs
NT Australia 0871
Ethics committee country [1] 294628 0
Australia
Date submitted for ethics approval [1] 294628 0
10/01/2013
Approval date [1] 294628 0
22/03/2013
Ethics approval number [1] 294628 0
HREC-13-119
Ethics committee name [2] 294629 0
Human Ethics Committee of the Northern Territory Department of Health
Ethics committee address [2] 294629 0
Menzies School of Health Research
PO Box 41096,
Casuarina NT 0811.
Ethics committee country [2] 294629 0
Australia
Date submitted for ethics approval [2] 294629 0
14/01/2013
Approval date [2] 294629 0
18/04/2013
Ethics approval number [2] 294629 0
HoMER12-1923

Summary
Brief summary
The TEAMSnet study is a research project which aims to improve diabetes and cardiovascular healthcare in Aboriginal and Torres Strait Islander communities. The project is developing and testing the use of internet and mobile technologies to provide diabetic retinopathy screening and coordinated diabetes and CVD care in three Aboriginal communities in remote and very remote parts of the Northern Territory.
The primary hypothesis is that participation in a culturally appropriate retinal imaging programme that includes education, care coordination and management will improve clinical outcomes, adherence to eye care and clinical visits, reduce hospitalizations and patient stress in dealing with self-management and that additional analyses of the retinal images will add value in indicating potential care plans that may impact on decreasing the risk for diabetic retinopathy progression.
Thus, in collaboration with Northern Territory Indigenous communities and their health care providers, we propose the overall goal of implementing and evaluating a telemedicine-supported diabetes and CVD assessment and care program to facilitate optimal healthcare delivery for Indigenous Australians. The project plans to implement an established primary care-based teleretinal eye assessment programme that acquires digital images of the retina, assesses visual acuity, and transmits, via secure telecommunication links, the data to a grading centre (at the Centre for Eye Research Australia [CERA]) for assessment of clinical retinopathy.
The project will also implement a telecommunications infrastructure that supports health information exchange between participating sites, CERA retinal grading centre and investigators. This includes a web-based telehealth Chronic Disease Management Program (CDMP), a clinical data repository that incorporates eye diagnoses and management recommendations, and a telehealth program for diabetes and CVD prevention and management.
The potential benefits include increased rates of timely eye screening for diabetic eye disease, the development an eye screening software technology that integrates within the primary care environment through integration with software based electronic decision support for facilitating optimal diabetes, cardiovascular disease and lifestyle management with the ultimate improvement in clinical outcomes such as blood glucose control (Haemoglobin A1c), lipid levels and blood pressure.
Trial website
Trial related presentations / publications
1. Telehealth Eye and Associated Medical Services Network [Presentation by L Brazionis CARPA conference, Alice Springs 2013]
2. Teleretinal Surveillance and Telehealth in Primary Care [Presentation by SE Bursell ATA conference, 2013]
3. Retinopathy and Novel Telemedicine Solutions in Indigenous Peoples: Telehealth Eye and Associated Medical Services Netowrk (TEAMSnet) [Presented by SE Bursell Internatiomnal Diabetes Federation conference, 2013]
4. TEAMSnet study [Presentation by L Brazionis International Diabetes Epidemiology Group conference, Melbourne Baker IDI 2014]
5. Combining Tele-ophthalmology and Electronic Decision Support (EDS) to Assist Chronic Disease Management in Remote Indigenous Communities. [Presented by SE Bursell at the Australasian Telehealth Society Conference, 2014]
6. Chronic Disease Management And Telehealth Research In Remote And Very Remote Australia [Presentation by L Brazionis ACTA 2015 International Clinical Trials Symposium Sydney October 2015]
7. MobileHealth RCT-An oxymoron?. {Presented by SE Bursell ACTA 2015 International Clinical Trials Symposium Sydney October 2015]
Public notes

Contacts
Principal investigator
Name 64226 0
Prof Sven-Erik Bursell
Address 64226 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77, Camperdown NSW 2050
Country 64226 0
Australia
Phone 64226 0
+61 2 8036 5241
Fax 64226 0
+61 2 0565 1863
Email 64226 0
[email protected]
Contact person for public queries
Name 64227 0
Laima Brazionis
Address 64227 0
Department of Medicine
The University of Melbourne
St Vincent's Hospital
Level 4 Clinical Sciences Building
29 Regent Street (corner of Princes and Regent Streets)
Fitzroy, Melbourne, VIC 3065
Australia
Country 64227 0
Australia
Phone 64227 0
+61 (0)417160043
Fax 64227 0
Email 64227 0
[email protected]
Contact person for scientific queries
Name 64228 0
Sven-Erik Bursell
Address 64228 0
NHMRC Clinical Trials Centre
University of Sydney
Locked Bag 77, Camperdown NSW 2050
Country 64228 0
Australia
Phone 64228 0
+61 2 8036 5241
Fax 64228 0
+61 2 0565 1863
Email 64228 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
EmbaseAn evaluation of the telehealth facilitation of diabetes and cardiovascular care in remote Australian Indigenous communities: - protocol for the telehealth eye and associated medical services network [TEAMSnet] project, a pre-post study design.2017https://dx.doi.org/10.1186/s12913-016-1967-4
EmbaseDiabetic retinopathy in a remote Indigenous primary healthcare population: a Central Australian diabetic retinopathy screening study in the Telehealth Eye and Associated Medical Services Network project.2018https://dx.doi.org/10.1111/dme.13596
EmbaseAssociations with sight-threatening diabetic macular oedema among Indigenous adults with type 2 diabetes attending an Indigenous primary care clinic in remote Australia: A Centre of Research Excellence in Diabetic Retinopathy and Telehealth Eye and Associated Medical Services Network study.2021https://dx.doi.org/10.1136/bmjophth-2020-000559
N.B. These documents automatically identified may not have been verified by the study sponsor.