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Trial registered on ANZCTR


Registration number
ACTRN12617000350325
Ethics application status
Approved
Date submitted
28/02/2017
Date registered
8/03/2017
Date last updated
10/12/2018
Date data sharing statement initially provided
10/12/2018
Date results information initially provided
10/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Safety and feasibility of a specialised diabetes team for the individualised management of older adults with type 2 diabetes
Scientific title
Older People with Type 2 diabetes - Individualising Management wIth a SpecialisEd community team: Safety and feasibility study
Secondary ID [1] 291276 0
None
Universal Trial Number (UTN)
Trial acronym
OPTIMISES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 302224 0
Condition category
Condition code
Metabolic and Endocrine 301822 301822 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will assess older clients newly registered to a community home nursing organisation that have been referred for diabetes management, and will identify each persons current management, including medications and community supports, and whether these are aligned with best practice (The McKellar Guidelines for Managing Older People with Diabetes in Residential and Other Care Settings; IDF Global Guideline for Managing Older People with Type 2 Diabetes; RACGP Guideline - General Practice Management of Type 2 Diabetes). We will ascertain the capacity of older participants for self-management and risk management, and a person-centred, individualised management plan will be developed by a Diabetes Team, consisting of a credentialled diabetes educator (CDE) and endocrinologist, working together with the older community member. The individualised management plan will take into account factors such as an individual’s glycaemic control, the functional status of the person, presence of comorbidities, and associated medical treatments. Participants will be reviewed by the endocrinologist via video-conferencing in the participant’s home with the participant and the CDE at baseline (week 2) and at 20 weeks after recruitment. It is anticipated the duration of each video-conference will be 30 minutes. Blood glucose management will be ascertained through the use of flash glucose monitoring, where data will be gathered for two weeks after recruitment into the study (week 0-2), and then two weeks after the 16-week intervention period (week 18-20). At 20 weeks the Diabetes Team will undertake the final review and we will review the impact of the intervention on measures important to community members, that is, quality of life, wellbeing, psychological distress and treatment satisfaction as well as biomedical markers, such as time spent outside optimum blood glucose target levels, hypoglycaemia episodes, HbA1c and safety, such as hospitalisations, recurrent infections and falls. Three months after the final review (approx. week 32), HbA1c will be collected.
Intervention code [1] 297290 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 301236 0
Primary safety outcome measure:
Primary safety outcome will be defined as participants having:
* BGLs which are:
>20 mmol/L less than 30% of the time.
<4 mmol/L less than 5% of the time.
* Do not have any of the following adverse events:
1 or more hospitalisations associated with diabetes.
Death associated with diabetes intervention.

The components of the composite primary safety outcome measure are:
* Percentage time clients are outside of safe BGLs of <4mmol/L and >20mmol/L.
* Hospitalisation associated with diabetes management.
* Mortality associated with diabetes management.
Timepoint [1] 301236 0
Post intervention (20 weeks)
Primary outcome [2] 301237 0
Primary feasibility outcome measure:
The intervention will be deemed “feasible” when:
* 80% participants recruited in to the study, agree to proceed with the intervention.
* 60% of participants complete the intervention.
The components of the primary feasibility outcome measure are:
* Number of participants recruited into the study and agreed to the intervention.
* Number who completed the intervention.
Timepoint [2] 301237 0
Post intervention (20 weeks)
Secondary outcome [1] 332084 0
Change in the number of hypoglycaemic events (assessed via flash glucose monitoring) pre and post Diabetes Team management.
Timepoint [1] 332084 0
Post intervention (20 weeks)
Secondary outcome [2] 332085 0
Proportion of participants achieving their target HbA1c post intervention (assessed using blood sample).
Timepoint [2] 332085 0
Post intervention (20 weeks)
Secondary outcome [3] 332086 0
Percentage change from baseline HbA1c
Timepoint [3] 332086 0
Post intervention (20 weeks)
Secondary outcome [4] 332087 0
Changes in psychological distress (K6) from baseline.
Timepoint [4] 332087 0
Post intervention (20 weeks)
Secondary outcome [5] 332088 0
Proportion of participants who need ongoing support from community nursing organisation after the four month intervention for injectable-related requirements. Assessed via service data
Timepoint [5] 332088 0
Post intervention (20 weeks)
Secondary outcome [6] 332089 0
Incidence of falls (patient self-report)
Timepoint [6] 332089 0
Post intervention (20 weeks)
Secondary outcome [7] 332090 0
Number of visits/phone calls by community nursing organisation to implement management program. Assessed using service data.
Timepoint [7] 332090 0
Post intervention (20 weeks)
Secondary outcome [8] 332361 0
Change in wellbeing (WHO-5) from baseline,
Timepoint [8] 332361 0
Post intervention (20 weeks)
Secondary outcome [9] 332362 0
Change in health status (EQ5D-5L) from baseline.
Timepoint [9] 332362 0
Post intervention (20 weeks)
Secondary outcome [10] 332363 0
Change in diabetes-dependent quality of life (ADDQoL 19) from baseline.
Timepoint [10] 332363 0
Post intervention (20 weeks)
Secondary outcome [11] 332364 0
Change in diabetes treatment satisfaction (DTSQ) from baseline.
Timepoint [11] 332364 0
Post intervention (20 weeks)
Secondary outcome [12] 332365 0
Proportion of participants who need ongoing support from community nursing organisation after the four month intervention for other diabetes management. Assessed using service data.
Timepoint [12] 332365 0
Post intervention (20 weeks)
Secondary outcome [13] 332366 0
Proportion of participants who need ongoing support from community nursing organisation after the four month intervention for other medication-related requirements. Assessed using service data.
Timepoint [13] 332366 0
Post intervention (20 weeks)
Secondary outcome [14] 332367 0
Incidence of infections (patient self-report)
Timepoint [14] 332367 0
Post intervention (20 weeks)
Secondary outcome [15] 332369 0
Incidence of hospitalisations or admissions where diabetes is coded as a comorbidity (combination of patient self-report and service data).
Timepoint [15] 332369 0
Post intervention (20 weeks)
Secondary outcome [16] 332370 0
Incidence of death (service data)
Timepoint [16] 332370 0
Post-intervention (20 weeks)
Secondary outcome [17] 332371 0
Duration of visits. Assessed using service data.
Timepoint [17] 332371 0
Post intervention (20 weeks)
Secondary outcome [18] 332372 0
Average time taken to discharge participant from diabetes team. Assessed using service data.
Timepoint [18] 332372 0
Post intervention (20 weeks)
Secondary outcome [19] 354818 0
Change in HbA1c. Assessed using serum assay.
Timepoint [19] 354818 0
post intervention (32 weeks)

Eligibility
Key inclusion criteria
All newly registered clients to a community nursing organisation who:
* are 65 years or older
* have been diagnosed with type 2 diabetes
* have been referred to the community nursing organisation for diabetes management
* can speak and understand English
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Are unable to consent, or don’t have a carer who is able to provide support for management of diabetes.
* Are under the care of an Endocrinologist, and who have been seen by the endocrinologist in the last six months.
* Do not currently have an acute infection, wound or recent change in condition that is affecting blood sugars
* Have been referred to the community nursing organisation for assistance commencing an injectable diabetes medication.
* Do not fit the inclusion criteria.

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)
Not applicable
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Simon’s two stage design will be used (Simon, 1989). The null hypothesis that the true proportion of patients without safety event is 0.6 (i.e. 60%) will be tested against a one-sided alternative. In the first stage, 11 patients will be accrued. If 7 or fewer patients in these 11 patients do not have a safety event (i.e. 4 or more patients do have a safety event), the study will be stopped. Otherwise, 32 additional patients will be accrued for a total of 43. The null hypothesis will be rejected if 31 or more patients do not have a safety event (i.e. 12 or less patients do have a safety event) in the total of 43 patients. This design yields a type I error rate of 0.05 and power of 0.8 when the true proportion of patients without a safety event is 0.8 (i.e. true proportion of patients with safety event is 0.2).
Baseline data will be descriptive, outlining the current status of older people seen by the community nursing organization, and their diabetes management. Quantitative data will be presented as proportions, means (standard deviations) or, for variables that did not conform to a normal or log-normal distribution, medians (interquartile range). Comparison of paired data will be by paired t-tests, McNemar’s test, or the Wilcoxon signed-rank test as appropriate. Statistical analysis will be performed using SPSS (version 21, IBM Armonk, New York, USA).

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 295741 0
Charities/Societies/Foundations
Name [1] 295741 0
RDNS Charitable Trust
Address [1] 295741 0
31 Alma Road, St Kilda VIC 3182
Country [1] 295741 0
Australia
Funding source category [2] 295752 0
Charities/Societies/Foundations
Name [2] 295752 0
H & L Hecht Trust
Address [2] 295752 0
Perpetual Trustees Australia Limited
GPO Box 4172, Sydney NSW 2001
Country [2] 295752 0
Australia
Funding source category [3] 295753 0
Commercial sector/Industry
Name [3] 295753 0
Sanofi Australia & New Zealand
Address [3] 295753 0
220 Coventry Street
South Melbourne VIC 3205
Country [3] 295753 0
Australia
Primary sponsor type
Individual
Name
Dr Rajna Ogrin
Address
Bolton Clarke Research Institute, Suite 1.01, 973 Nepean Highway, Bentleigh, VIC 3204
Country
Australia
Secondary sponsor category [1] 294582 0
Individual
Name [1] 294582 0
Dr Elif Ekinci
Address [1] 294582 0
Austin Health, 145 Studley Road, Heidelberg, VIC 3084
Country [1] 294582 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297041 0
Bolton Clarke Human Research Ethics Committee
Ethics committee address [1] 297041 0
Level 1, 347 Burwood Highway, Forest Hill, VIC 3131
Ethics committee country [1] 297041 0
Australia
Date submitted for ethics approval [1] 297041 0
Approval date [1] 297041 0
23/02/2017
Ethics approval number [1] 297041 0
183
Ethics committee name [2] 297053 0
Austin Health Human Research Ethics Committee
Ethics committee address [2] 297053 0
PO Box 5555, Heidelberg, VIC 3084
Ethics committee country [2] 297053 0
Australia
Date submitted for ethics approval [2] 297053 0
Approval date [2] 297053 0
20/02/2017
Ethics approval number [2] 297053 0
HREC/16/Austin/496

Summary
Brief summary
In this study, 43 people with diabetes referred to a community nursing organisation which visits patients in their home will be recruited in a prospective study. The current diabetes management of this group will be described. Participants’ individual needs will be assessed by a Diabetes Team, consisting of an endocrinologist linked to an in-home credentialled diabetes educator (CDE) through video-conferencing. The impact of individualised management on outcomes important to older people, that is, quality of life, wellbeing, treatment satisfaction, as well as biomedical markers will then determine the resources needed to undertake the assessments and management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 72782 0
Dr Rajna Ogrin
Address 72782 0
Bolton Clarke, Suite 1.01, 973 Nepean Highway, Bentleigh, Victoria 3204
Country 72782 0
Australia
Phone 72782 0
+61 3 9536 5245
Fax 72782 0
+61 3 9537 0282
Email 72782 0
rogrin@boltonclarke.com.au
Contact person for public queries
Name 72783 0
Dr Rajna Ogrin
Address 72783 0
Bolton Clarke, Suite 1.01, 973 Nepean Highway, Bentleigh, Victoria 3204
Country 72783 0
Australia
Phone 72783 0
+61 3 9536 5245
Fax 72783 0
+61 3 9537 0282
Email 72783 0
rogrin@boltonclarke.com.au
Contact person for scientific queries
Name 72784 0
Dr Rajna Ogrin
Address 72784 0
Bolton Clarke, Suite 1.01, 973 Nepean Highway, Bentleigh, Victoria 3204
Country 72784 0
Australia
Phone 72784 0
+61 3 9536 5245
Fax 72784 0
+61 3 9537 0282
Email 72784 0
rogrin@boltonclarke.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Undecided
No/undecided IPD sharing reason/comment
Will need to discuss with the team
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary