Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12615001138572
Ethics application status
Approved
Date submitted
26/07/2015
Date registered
27/10/2015
Date last updated
27/10/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Implementation and Evaluation of a Systems Navigation Model of Transition and Care for Non-Metropolitan Young Adults with Type 1 Diabetes: Youth OutReach for Diabetes (YOuR Diabetes) – A Cluster Randomised Controlled Trial in Hunter New England
Scientific title
The implementation and evaluation of a Systems Navigation Model of Transition and Care on the use of planned, routine services for preventive, educative and monitoring care among Non-Metropolitan Young Adults with Type 1 Diabetes - A Cluster Randomised Controlled Trial in Hunter New England
Secondary ID [1] 287147 0
Nil
Universal Trial Number (UTN)
U1111-1172-5733
Trial acronym
YOuR-Diabetes
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes 295700 0
Public Health 295766 0
Condition category
Condition code
Metabolic and Endocrine 295986 295986 0 0
Diabetes
Public Health 296049 296049 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A Systems Navigation Model of Transitional Care comprising:
a) a transition preparation educational programme initiated and delivered on a combination of 1:1 and group basis by diabetes nurses educators employed by the local public health paediatric services, tailored to individual need (ie number of sessions will depend on assessment outcomes) within an agreed topic framework. The topic framework entails and records delivery of:
Age 14 years: Assessment of diabetes knowledge, dietary and social work review, mental health assessment. Education covered: diabetes ‘Sick Day’ management; Insulin therapy and insulin adjustment; school issues and school camp; management of ‘hypos’; effects of puberty on diabetes; exercise and diabetes; diabetes complication screening; diabetes control; parental support and ‘letting go’; job rights at work.
Age 15 years: options for adult care discussed with the young person; dietary and social work review and mental health assessment. Education delivered at this time: alcohol and related issues; diabetes and sexuality; feelings and emotions – burn out; confidentiality; Government allowances; smoking and recreational drugs; getting a driver’s licence; obtaining a Medicare card; getting a job – rights at work; what to expect from a medical consultation; parental support and ‘letting go’.
Age 16-17 years: Re-assessment of diabetes knowledge and skills based on previous years’ content. Discuss options for adult care with the young person and their family; dietary and social work review and mental health assessment; referrals made to the ACI Transition Care Coordinator, the Diabetes Care Coordinator and Connecting Care service care coordinator; Education delivered/ discussed at this time: alcohol and related issues; HSC and school stress; smoking and recreational drugs; getting a driver’s licence; tertiary study; parental support and ‘letting go’; getting a job-rights at work; diabetes and travel; public health care system and costs; diabetes and sexuality; NDSS; obtaining a Medicare card; diabetes and ‘schoolies’ week; feelings and emotions – burn out; how to actively participate in a medical consultation. A Transition Clinic visit is arranged and letter sent to the GP discussing transition; joint or alternating visits may occur with paediatric and adult teams.
Age 18+ years: Prior to transfer: re-assess diabetes knowledge and skills/ address any knowledge deficits; dietary and social work review and mental health review; arrange appropriate supplies, medications and prescriptions; make referral/ arrange discharge summary to adult diabetes service/doctor, GP and Transition Coordinator.
Session frequency and duration will be recorded - the aim is for each participant to achieve knowledge and skills for self-management in line with the framework established for each age band. We are not aiming to simply spend a pre-set amount of time with participants, but to deliver the learning required for each individual. We will record duration and staff involved with every contact so we can estimate 'dosage' in relation to outcomes.

b) a searchable clinical database of young people, their service contacts and outcomes, allowing clinicians easy access to monitor individual patient contacts and clinical data;

c) a ‘Systems Navigation’ coordinator with a directory and comprehensive knowledge of and links to local service providers, who will conduct a needs assessment and liaise between patients and service providers, and function as a single point of contact for healthcare professionals, young people and families;

d) an educational programme for rural healthcare practitioners on care planning for support and management of T1DM in young people, offering a minimum of 1 session attendance face to face with an endocrinologist, diabetes nurse educator, dietitian and social worker; at least one session delivered in each location every year; attendees free to attend in line with personal preference - multiple attendances acceptable if preferred; these will be group sessions, with a register of attendance, and content addressing the full range of clinical needs for care of young people with type 1 diabetes, with each session tailored to local preference.

e) a locally tailored consumer-led programme of educational, social and peer support activities for young people, to be developed in response to locally-identified needs and preferences canvassed through a local survey/ interviews/ website, managed by a joint consumer/ healthcare professional management group.
Overall intervention duration 2 years.
Intervention code [1] 292414 0
Treatment: Other
Intervention code [2] 292473 0
Behaviour
Intervention code [3] 292474 0
Lifestyle
Comparator / control treatment
Current practice, which principally comprises whatever services and support local GPs are able to offer, supplemented by contact with (principally) physicians in larger towns, where patients are able to travel to access this. Our prior publications have shown this varies between GP practices and locations but mainly comprises 1:1 support from a GP/ practice staff.
Control group
Active

Outcomes
Primary outcome [1] 295656 0
Use of planned, routine services for preventive, educative and monitoring care, as recorded in the local service providers' databases.
Timepoint [1] 295656 0
At 12months and 24 months from recruitment
Primary outcome [2] 295716 0
Consumer-rated service satisfaction, of paediatric services compared to adult services measured using a Visual Analogue Scale and the Diabetes Treatment Satisfaction questionnaire.
Timepoint [2] 295716 0
Paediatric services rated at point of transfer compared to adult services rated at the end of the first year.
Primary outcome [3] 295717 0
Costs of all diabetes-related services provided to these young people from the provider (HNEH) perspective, comparing current versus new models, costs adjusted to 2012 values. Data utilised will be volume and unit costs of routine services, available from the public health provider.
Timepoint [3] 295717 0
At 12 months and 24 months.
Secondary outcome [1] 316126 0
HbA1c measurements, extracted from routine healthcare records
Timepoint [1] 316126 0
At 12 and 24 months
Secondary outcome [2] 316299 0
Process evaluation: content analysis and narrative synthesis will identify key elements and uptake of the implementation processes.
Timepoint [2] 316299 0
Throughout, and up to 24 months

Eligibility
Key inclusion criteria
Young people (aged 18 to 30 years) with T1DM
maintained as young adults by Hunter New England Local Health District services
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Not type 1 diabetes

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Cluster randomized controlled trial; 8 service clusters to be randomized to either intervention or control with outcomes assessed at the patient level. Individuals will be recruited in line with eligibility criteria and allocated in line with the allocation of the cluster in which they reside.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation of clusters occurs at service centre level by random number generation and sealed envelopes; individuals are not allocated.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed on intention to treat basis and the analysis population will be all young people with T1DM transitioning from paediatric to adult services and maintained as young adults by HNEH.
As this is a clustered RCT all analyses will be conducted within a generalised estimating equation (GEE) framework to take account of clustering of patients within service clusters. A Poisson regression model will be used to determine if there is a statistically significant difference between the mean
number of services used per person in the intervention and control groups. The outcome in the Poisson regression model will be the number of services used by the subject, the predictor variable of interest will be treatment group (intervention or control) and the clustering unit would be the service unit.
The sample size calculation is based on the primary outcome measure being analysed using Poisson regression with an over dispersion parameter of 1.2. Assuming recruitment of an average of 19 subjects per cluster and an intra cluster correlation coefficient of 0.05, study design effect will be 1.9. Therefore 152 subjects (76 per treatment arm) will give the study 80% power to detect an improvement in the use of planned services from a mean of 1.3 in the control group to a mean of 3 per year in the treatment group. We assume that increasing average service contacts by young people from 1.3 to 3 per year (i.e. to meet guideline recommendations) is a significant improvement. With approximately 80 people transitioning from paediatric to adult services each year and recruitment for 30 months 200 people would be available for recruitment, which would allow for a 24% non-response rate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2015
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 291716 0
Government body
Name [1] 291716 0
NHMRC Partnership Grant
Country [1] 291716 0
Australia
Primary sponsor type
University
Name
University of Newcastle
Address
University Drive
Callaghan NSW 2308
Australia
Country
Australia
Secondary sponsor category [1] 290388 0
Government body
Name [1] 290388 0
Hunter New England Local Health District
Address [1] 290388 0
Lookout Rd, New Lambton NSW 2305
Country [1] 290388 0
Australia
Other collaborator category [1] 278549 0
Charities/Societies/Foundations
Name [1] 278549 0
Diabetes NSW
Address [1] 278549 0
26 Arundel Street
Glebe, NSW 2037
Country [1] 278549 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293237 0
Hunter New England HREC
Ethics committee address [1] 293237 0
Ethics committee country [1] 293237 0
Australia
Date submitted for ethics approval [1] 293237 0
Approval date [1] 293237 0
09/10/2007
Ethics approval number [1] 293237 0
07/09/19/4.01
Ethics committee name [2] 293238 0
University of Newcastle HREC
Ethics committee address [2] 293238 0
Ethics committee country [2] 293238 0
Australia
Date submitted for ethics approval [2] 293238 0
Approval date [2] 293238 0
Ethics approval number [2] 293238 0
H-634-1107

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

Contacts
Principal investigator
Name 59014 0
Prof Lin Perry
Address 59014 0
Prince of Wales Hospital
Barker St.,
Randwick
NSW 2031
Country 59014 0
Australia
Phone 59014 0
0061 2 9382 4709
Fax 59014 0
Email 59014 0
[email protected]
Contact person for public queries
Name 59015 0
Lin Perry
Address 59015 0
Prince of Wales Hospital
Barker St.,
Randwick
NSW 2031
Country 59015 0
Australia
Phone 59015 0
0061 2 9382 4709
Fax 59015 0
Email 59015 0
[email protected]
Contact person for scientific queries
Name 59016 0
Lin Perry
Address 59016 0
Prince of Wales Hospital
Barker St.,
Randwick
NSW 2031
Country 59016 0
Australia
Phone 59016 0
0061 2 9382 4709
Fax 59016 0
Email 59016 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
No additional documents have been identified.