Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000477123
Ethics application status
Approved
Date submitted
4/12/2018
Date registered
22/03/2019
Date last updated
12/03/2021
Date data sharing statement initially provided
22/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
A Comparison of Two Different Models of Care for People with Diabetes in the Yarra Ranges.
Scientific title
A Comparison of Two Different Models of Care for People with Diabetes in the Yarra Ranges.
Secondary ID [1] 296775 0
None
Universal Trial Number (UTN)
Trial acronym
TDM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes 310667 0
Condition category
Condition code
Metabolic and Endocrine 309370 309370 0 0
Diabetes

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
6
Target follow-up type
Months
Description of intervention(s) / exposure
1. The new model of care will include a range of community based allied health services to manage diabetes incorporating a broad and comprehensive general assessment, endocrinology consultations, education and programs to support lifestyle and behaviour change based within a community setting. The main difference in the new model of care compared to the existing model is that there is an endocrinologist consulting and contact with key health workers can occur at the one appointment.
2. This project involves for participants the opportunity to potentially benefit from greater satisfaction in their treatment for their diabetes in the IDEAS clinic via improved processes and am improved model of care for diabetes. The overall time commitment will be the 90minutes of their scheduled appointment time when they attend either the INSPIRO clinic or the IDEAS clinic over a period of 6months, i.e. at baseline, 3months and 6months
Intervention code [1] 313081 0
Early Detection / Screening
Comparator / control treatment
The existing model of care within INSPIRO incorporates one appointment at a time with a key health worker/health professional Referrals are then made for another appointment with another health professional for a later date.The control is to compare a range of diabetes related outcomes related to participation in the existing model of care for people with diabetes within Inspiro Community Health v the new model of diabetes care in the IDEAS clinic. The main difference in the new model of care compared to the existing model is that there is an endocrinologist consulting and contact with key health workers can occur at the one appointment.
Control group
Active

Outcomes
Primary outcome [1] 308329 0
% of attendance to the Inspiro Diabetes clinic is the primary outcome to be assessed.
Instrument to be used in the assessment will be the appointment making program "Trak", via data linkage to medical records which records attendance/failure to attend.
Timepoint [1] 308329 0
Timepoint: at baseline (i.e. first visit to clinic); 3m and 6m. post enrolment
Primary outcome [2] 319503 0
% of attendance to the IDEAS diabetes clinic is the second primary outcome to be assessed.
Instrument to be used in the assessment will be the appointment making program "Trak", via data linkage to medical records which records attendance/failure to attend.
Timepoint [2] 319503 0
Timepoint: at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement
Secondary outcome [1] 354621 0
Secondary outcome
1. Assessment of HbA1c using a measure of glycated hemoglobin as reported in patient records.
Timepoint [1] 354621 0
Timepoint: at baseline (i.e. first visit to clinic); 3m and 6m. post enrolment
Secondary outcome [2] 368338 0
Secondary outcome
2. Assessment of waist circumference using standardised circumference measurement tape as reported in patient records.
Timepoint [2] 368338 0
Timepoint: at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement
Secondary outcome [3] 368339 0
Secondary outcome :
3. Assessment of macrovascular measures, including presence of cardiovascular disease using the Inspiro and IDEAS Initial Assessment forms as reported in patient records.
Timepoint [3] 368339 0
Timepoint: at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement
Secondary outcome [4] 368340 0
Secondary outcome :
4. Mental health symptoms data (assessed by Diabetes Anxiety Depression Scale (DADS),
Timepoint [4] 368340 0
Timepoint: at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement
Secondary outcome [5] 368341 0
Secondary outcome :
5. Self efficacy data ( assessed by Problem Areas in Diabetes scale (PAID)
Timepoint [5] 368341 0
Timepoint: :at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement
Secondary outcome [6] 368342 0
Secondary outcome :
6. Patient reported outcome measures (assessed by PROMS - in DADS, questions 10-13)
Timepoint [6] 368342 0
Timepoint: :at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement
Secondary outcome [7] 368501 0
Secondary outcome :
7. Assessment of macrovascular measures, including presence of ischaemic heart disease using the Inspiro and IDEAS Initial Assessment forms as reported in patient records.
Timepoint [7] 368501 0
Timepoint: :at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement
Secondary outcome [8] 368502 0
Assessment of macrovascular measures including peripheral vascular disease using the Inspiro and IDEAS Initial Assessment forms as reported in patient records.
Timepoint [8] 368502 0
Timepoint: :at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement.
Secondary outcome [9] 368503 0
Assessment of microvascular measures, including presence of retinopathy using the Inspiro and IDEAS Initial Assessment forms as reported in patient records.
Timepoint [9] 368503 0
Timepoint: :at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement.
Secondary outcome [10] 368504 0
Assessment of microvascular measures, including presence of nephropathy using the Inspiro and IDEAS Initial Assessment forms as reported in patient records.
Timepoint [10] 368504 0
Timepoint: :at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement.
Secondary outcome [11] 368505 0
Assessment of microvascular measures, including presence of peripheral neuropathy using the Inspiro and IDEAS Initial Assessment forms as reported in patient records.
Timepoint [11] 368505 0
Timepoint: :at baseline (i.e. first visit to clinic); 3m and 6m. post enrolement.

Eligibility
Key inclusion criteria
The eligibility criteria extends to people with diabetes within INSPIRO's catchment area in the Yarra Ranges Shire who have been referred to the service.
All participants will be people with diabetes, >18 years of age, able to communicated fluently in verbal and written English, and have the capacity 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
Exclusion criteria that would be considered includes severe diabetes-related complications, pregnancy, severe mental illness, cognitive impairment.

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Case control
Timing
Prospective
Statistical methods / analysis
This project is a pilot feasibility trial being conducted over 6months. We therefore believe it is appropriate to recruit 50 participants for each group. Fifty participants is a purposeful convenience sample not based on power calculations. The complete available sample within the specific local community setting of people with diabetes will be invited to participate. There are likely to be 64 potential participants over a 6month time period, hence 50 is used as being a goal to allow for attrition and those not willing to participate.


Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
27/03/2019
Actual
10/04/2019
Date of last participant enrolment
Anticipated
18/12/2019
Actual
12/12/2019
Date of last data collection
Anticipated
18/06/2020
Actual
13/05/2020
Sample size
Target
50
Accrual to date
Final
75
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 25050 0
3140 - Lilydale

Funding & Sponsors
Funding source category [1] 301351 0
Charities/Societies/Foundations
Name [1] 301351 0
INSPIRO
Country [1] 301351 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
1 Kingsbury Drive
Bundoora, Victoria 3086, Australia
Country
Australia
Secondary sponsor category [1] 301026 0
None
Name [1] 301026 0
Address [1] 301026 0
Country [1] 301026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302095 0
La Trobe University SHE College Human Ethics Committee
Ethics committee address [1] 302095 0
Ethics committee country [1] 302095 0
Australia
Date submitted for ethics approval [1] 302095 0
04/12/2018
Approval date [1] 302095 0
13/12/2018
Ethics approval number [1] 302095 0

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

Contacts
Principal investigator
Name 89090 0
Dr Adrienne Forsyth
Address 89090 0
Dr Adrienne Forsyth MSc MEd PhD
Senior Lecturer, Dietetics & Human Nutrition
Course Coordinator, Bachelor of Human Nutrition
Department of Rehabilitation, Nutrition and Sport
College of Science, Health and Engineering | La Trobe University | Bundoora 3086
Victoria
Country 89090 0
Australia
Phone 89090 0
61 3 9479 6059
Fax 89090 0
Email 89090 0
[email protected]
Contact person for public queries
Name 89091 0
Adrienne Forsyth
Address 89091 0
Dr Adrienne Forsyth MSc MEd PhD
Senior Lecturer, Dietetics & Human Nutrition
Course Coordinator, Bachelor of Human Nutrition
Department of Rehabilitation, Nutrition and Sport
College of Science, Health and Engineering | La Trobe University | Bundoora 3086
Victoria
Country 89091 0
Australia
Phone 89091 0
61 3 9479 6059
Fax 89091 0
Email 89091 0
[email protected]
Contact person for scientific queries
Name 89092 0
Adrienne Forsyth
Address 89092 0
Dr Adrienne Forsyth MSc MEd PhD
Senior Lecturer, Dietetics & Human Nutrition
Course Coordinator, Bachelor of Human Nutrition
Department of Rehabilitation, Nutrition and Sport
College of Science, Health and Engineering | La Trobe University | Bundoora 3086
Victoria
Country 89092 0
Australia
Phone 89092 0
61 3 9479 6059
Fax 89092 0
Email 89092 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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.