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Trial registered on ANZCTR


Registration number
ACTRN12611001012965
Ethics application status
Approved
Date submitted
20/09/2011
Date registered
21/09/2011
Date last updated
11/07/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
A randomised control trial of the impact of the implementation of case management compared with usual care in the transition of young adults with type 1 diabetes mellitus from paediatric to adult services
Scientific title
In adolescents with type 1 diabetes mellitus (T1DM) who are undergoing transition from paediatric diabetes services at the Royal Children's Hopsital, Melbourne, Australia to adult diabetes services in the Melbourne Metropolitan area, is a case management programme more effective than standard care as assessed by frequency of clinic attendance at 12 months post transition to adult services?
Secondary ID [1] 263055 0
Nil
Universal Trial Number (UTN)
U1111-1124-6064
Trial acronym
TrACeD (Transition to Adult Care in type 1 Diabetes)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 1 Diabetes Mellitus 270790 0
Condition category
Condition code
Metabolic and Endocrine 270977 270977 0 0
Diabetes
Public Health 271016 271016 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
At recruitment, baseline details on all participants will be documented (demographics, date of diagnosis of diabetes, HbA1c). Each participant will be given instructions on how to access and complete the web-based assessment questionnaire. This will be administered via the Survey Monkey application using clinic-based computers. Included in this survey will be an assessment of; personality (NEO-fFI Five Factor Inventory), mental state (Hospital Anxiety and Depression Scale – HADS) and diabetes-specific ‘readiness to transition’ (ARCh). Together, these tools form 146 questions, and combined these tasks will take approximately 30 minutes to complete using Survey Monkey technology. The ARCh is a novel tool, developed at RCH, and we hope to validate its use as part of the analysis of this trial. The intervention group alone will undergo case management. Each participant in this group will be asked to give their most appropriate contact details to the PI (e.g. mobile phone number, home telephone number, email address). A personalised transition schedule will be given to each member of this group at the final paediatric clinic visit, detailing contact and clinic details (location, contact phone numbers to confirm or reschedule clinic appointments) for the appointed adult centre of referral, as well as details of the first clinic visit (time and date). Each participant in this group will also be given a password protected USB memory stick, with relevant personal medical data (transition referral letter, clinic letters, recent laboratory results, other relevant clinical details). The PI will be the designated contact person for all queries and problems surrounding the transition process, and will give each participant in the intervention group her contact details (office and mobile phone numbers, work email address) in the form of a business card. The PI will assume responsibility for ensuring adult clinic appointment allocation, and will send a reminder SMS text message to remind each participant of the appropriate time and date within 48 hours of the scheduled clinic visit. If participants fail to attend for any of their clinic appointments, the PI will ensure automatic rebooking for the next available appointment, and will contact the participant directly by SMS/phone call to ensure receipt of appointment details.
Intervention code [1] 269403 0
Treatment: Other
Intervention code [2] 269435 0
Prevention
Comparator / control treatment
At recruitment, baseline details on all participants will be documented (demographics, date of diagnosis of diabetes, HbA1c). Each participant will be given instructions on how to access and complete the web-based assessment questionnaire. This will be administered via the Survey Monkey application using clinic-based computers. Included in this survey will be an assessment of; personality (NEO-fFI Five Factor Inventory), mental state (Hospital Anxiety and Depression Scale – HADS) and diabetes-specific ‘readiness to transition’ (ARCh). Together, these tools form 146 questions, and combined these tasks will take approximately 30 minutes to complete using Survey Monkey technology. The ARCh is a novel tool, developed at RCH, and we hope to validate its use as part of the analysis of this trial. Current standard of care for transferring youth with T1DM to adult diabetes services involves a discussion with the youth about possible referral options, with the patient ultimately deciding on the most appropriate adult centre for them. No specific adult clinic details are currently given to our patients, and once a transition referral letter has been sent, essentially youth are considered to have been transitioned. This standard of care practice will continue for the control group. The details of the adult centre that the participant has chosen to attend for ongoing diabetes care will be documented by the PI.
Control group
Active

Outcomes
Primary outcome [1] 279645 0
Mean frequency of attendance at adult diabetes clinic appointments over 12 months post transition from paediatric diabetes services at RCH, thereby assessing the number of participants who disengage from specialist services. The PI will contact the relevant adult centre for each participant after each scheduled visit to document clinic outcome.
Timepoint [1] 279645 0
12 months post transition from the paediatric diabetes service
Secondary outcome [1] 294112 0
Glycaemic control (as judged by HbA1c) at 12 months post transition from paediatric services at RCH. The PI will contact the relevant adult centre for each participant after each scheduled visit to document the HbA1c.
Timepoint [1] 294112 0
12 months post transition from the paediatric diabetes service
Secondary outcome [2] 294113 0
Mean frequency of attendance at adult clinic appointments over 24 months post transition from paediatric diabetes services at RCH. The PI will contact the relevant adult centre for each participant after each scheduled visit to document clinic outcome
Timepoint [2] 294113 0
24 months post transition from the paediatric diabetes service
Secondary outcome [3] 294114 0
To assess how psychological factors such as core personality traits (Neo-Ffi), anxiety and depression levels (HADS) and 'readiness to transition' (ARCh) moderate the effect of case management on the mean frequency of hospital attendance after transition from paediatric to adult services
Timepoint [3] 294114 0
At recruitment and 12 months post transition from the paediatric diabetes service.
Secondary outcome [4] 325558 0
Glycaemic control (in terms of mean HbA1c) over the first and second 12 months post transition
Timepoint [4] 325558 0
12 and 24 months post transition

Eligibility
Key inclusion criteria
1) Youth with T1DM aged 17-19 years regardless of diabetes-related complication status or co-morbidity i.e. nephropathy, retinopathy, coeliac disease, thyroid disease, known mental health issues
2) Youth scheduled for transition to adult diabetes services between January 2012 and March 2013
3) Youth who wish to transition to any of the adult centres in the Melbourne metropolitan area
4) Youth must have the capacity to give informed consent i.e. they must be either greater than or equal to 18 years of age or be deemed to be a ‘mature minor’ by the PI
Minimum age
17 Years
Maximum age
19 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Non-T1DM i.e. Type 2 diabetes mellitus, Cystic fibrosis-related diabetes or steroid-induced diabetes
2) Non-English speaking as follow-up communication will be necessary by telephone and a command of the English language is required to complete the questionnaire assessments
3) The presence of any complex medical background which may affect the frequency of hospital clinic visits. Specifically potential participants will be excluded if they have any complex physical or intellectual disabilities, or any complex medical conditions which require regular in-patient or out-patient contact with non-diabetes hospital departments on an ongoing basis

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e. computerised sequence generation)
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
Completed
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
Recruitment hospital [1] 6147 0
The Royal Childrens Hospital - Parkville

Funding & Sponsors
Funding source category [1] 269871 0
Charities/Societies/Foundations
Name [1] 269871 0
Murdoch Children's Research Institute
Address [1] 269871 0
The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052
Country [1] 269871 0
Australia
Funding source category [2] 294030 0
Charities/Societies/Foundations
Name [2] 294030 0
Australasian Paediatric Endocrine Group (APEG)
Address [2] 294030 0
APEG Secretariat
PO Box 180
Morisset NSW 2264
AUSTRALIA
Country [2] 294030 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Murdoch Children's Research Institute
Address
The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052
Country
Australia
Secondary sponsor category [1] 268890 0
None
Name [1] 268890 0
Address [1] 268890 0
Country [1] 268890 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 271840 0
Royal Children's Hospital HREC
Ethics committee address [1] 271840 0
Human Research Ethics Committee, The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052
Ethics committee country [1] 271840 0
Australia
Date submitted for ethics approval [1] 271840 0
20/12/2010
Approval date [1] 271840 0
30/05/2016
Ethics approval number [1] 271840 0
31215
Ethics committee name [2] 295439 0
Melbourne Health HREC
Ethics committee address [2] 295439 0
Royal Melbourne Hospital,
Grattan Street,
Parkville
Ethics committee country [2] 295439 0
Australia
Date submitted for ethics approval [2] 295439 0
01/01/2012
Approval date [2] 295439 0
23/02/2012
Ethics approval number [2] 295439 0
QA2012019
Ethics committee name [3] 295440 0
Alfred HREC
Ethics committee address [3] 295440 0
Alfred Hospital,
Commercial Road,
Prahran,
Melbourne
Ethics committee country [3] 295440 0
Australia
Date submitted for ethics approval [3] 295440 0
01/01/2012
Approval date [3] 295440 0
08/06/2012
Ethics approval number [3] 295440 0
156/12
Ethics committee name [4] 295441 0
Austin Health HREC
Ethics committee address [4] 295441 0
Austin Hospital, Heidelberg
Ethics committee country [4] 295441 0
Australia
Date submitted for ethics approval [4] 295441 0
01/01/2012
Approval date [4] 295441 0
22/08/2012
Ethics approval number [4] 295441 0
04649
Ethics committee name [5] 295442 0
Eastern Health HREC
Ethics committee address [5] 295442 0
Box Hill Hospital, Box Hill, Melbourne
Ethics committee country [5] 295442 0
Australia
Date submitted for ethics approval [5] 295442 0
01/01/2012
Approval date [5] 295442 0
23/08/2012
Ethics approval number [5] 295442 0
LR97/1112
Ethics committee name [6] 295443 0
Monash Health HREC
Ethics committee address [6] 295443 0
Monash Health, Clayton, Melbourne
Ethics committee country [6] 295443 0
Australia
Date submitted for ethics approval [6] 295443 0
01/01/2012
Approval date [6] 295443 0
25/05/2012
Ethics approval number [6] 295443 0
12164Q
Ethics committee name [7] 295444 0
Northern Health HREC
Ethics committee address [7] 295444 0
Northern Hospital, Epping, Melbourne
Ethics committee country [7] 295444 0
Australia
Date submitted for ethics approval [7] 295444 0
01/01/2012
Approval date [7] 295444 0
17/09/2012
Ethics approval number [7] 295444 0
LR29/12

Summary
Brief summary
The incidence of Type 1 diabetes mellitus (T1DM) has increased over the last several decades, for reasons which are largely unclear. It is an autoimmune process characterised by a lack of insulin. This insulin deficiency leads to elevated blood sugars, which in turn causes damage to the small blood vessels and nerves in the body, leading to problems such as kidney failure, blindness and lack of blood flow to essential organs. The aim of management is to minimise the risk of these potential complications by ensuring that blood sugar levels are maintained as close to normal as possible. Despite increasing medical knowledge and technological advances, this remains a difficult goal to achieve, particularly during adolescence. In addition to the decreasing metabolic control during young adulthood, we know that many young adults with T1DM have difficulty maintaining contact with hospital services after transfer from paediatric to adult services. This lack of engagement with medical professionals often leads to a further deterioration in blood sugar control during this time, putting these vulnerable young adults at significant risk of long term health problems. The issue of transition in T1DM is one with which clinicians struggle with worldwide. Interventions such as continuity of treating physician or continuing attendance at a paediatric centre into the third decade are effective but not practical in most centres. Case management during adolescence has been shown to be effective at improving clinic attendance for teenagers, but to date there is no randomised controlled trial of case management in the transition of youth with T1DM. We hypothesise that a case management programme in this population will lead to improved clinic attendance rates after transfer to the adult services, and is both feasible and reproducible.
Trial website
Trial related presentations / publications
Public notes
Participants were recruited from the Royal Children's Hospital, only after Ethical approval was granted. Due to the complexity of the Ethics process at multiple sites, there were varying delays obtaining approval at external sites. No follow up data was collected from any individual from any site until approval had been granted at that site.

Contacts
Principal investigator
Name 33167 0
Dr Dr Mary White
Address 33167 0
Department of Endocrinology and Diabetes, Murdoch Children's Research Institute at The Royal Children's Hospital, 50 Flemington Road, Parkville, Melbourne, VIC 3168, Australia
Country 33167 0
Australia
Phone 33167 0
+61393455951
Fax 33167 0
Email 33167 0
mary.white@rch.org.au
Contact person for public queries
Name 16414 0
Dr Dr Mary White
Address 16414 0
Department of Endocrinology & Diabetes,
Murdoch Children's Research Institute at The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052
Country 16414 0
Australia
Phone 16414 0
+61393455951
Fax 16414 0
+61393477763
Email 16414 0
mary.white@rch.org.au
Contact person for scientific queries
Name 7342 0
Dr Dr Mary White
Address 7342 0
Department of Endocrinology & Diabetes,
Murdoch Children's Research Institute at The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052
Country 7342 0
Australia
Phone 7342 0
+61393455951
Fax 7342 0
+61393477763
Email 7342 0
mary.white@rch.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary