ANZCTR - Registration

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]

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

Condition category

Condition code

Metabolic and Endocrine

Diabetes

Public Health

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]

Treatment: Other

Intervention code [2]

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]

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]

12 months post transition from the paediatric diabetes service

Secondary outcome [1]

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]

12 months post transition from the paediatric diabetes service

Secondary outcome [2]

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]

24 months post transition from the paediatric diabetes service

Secondary outcome [3]

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]

At recruitment and 12 months post transition from the paediatric diabetes service.

Secondary outcome [4]

Glycaemic control (in terms of mean HbA1c) over the first and second 12 months post transition

Timepoint [4]

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

Sex

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

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/01/2012

Actual

4/01/2012

Date of last participant enrolment

Anticipated

31/12/2014

Actual

26/11/2014

Date of last data collection

Anticipated

Actual

31/12/2015

Sample size

Target

120

Accrual to date

Final

120

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Royal Childrens Hospital - Parkville

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Murdoch Children's Research Institute

Country [1]

Australia

Funding source category [2]

Charities/Societies/Foundations

Name [2]

Australasian Paediatric Endocrine Group (APEG)

Country [2]

Australia

Primary sponsor type

Charities/Societies/Foundations

Name

Murdoch Children's Research Institute

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Children's Hospital HREC

Ethics committee address [1]

Human Research Ethics Committee, The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

20/12/2010

Approval date [1]

30/05/2016

Ethics approval number [1]

31215

Ethics committee name [2]

Melbourne Health HREC

Ethics committee address [2]

Royal Melbourne Hospital,
Grattan Street,
Parkville

Ethics committee country [2]

Australia

Date submitted for ethics approval [2]

01/01/2012

Approval date [2]

23/02/2012

Ethics approval number [2]

QA2012019

Ethics committee name [3]

Alfred HREC

Ethics committee address [3]

Alfred Hospital,
Commercial Road,
Prahran,
Melbourne

Ethics committee country [3]

Australia

Date submitted for ethics approval [3]

01/01/2012

Approval date [3]

08/06/2012

Ethics approval number [3]

156/12

Ethics committee name [4]

Austin Health HREC

Ethics committee address [4]

Austin Hospital, Heidelberg

Ethics committee country [4]

Australia

Date submitted for ethics approval [4]

01/01/2012

Approval date [4]

22/08/2012

Ethics approval number [4]

04649

Ethics committee name [5]

Eastern Health HREC

Ethics committee address [5]

Box Hill Hospital, Box Hill, Melbourne

Ethics committee country [5]

Australia

Date submitted for ethics approval [5]

01/01/2012

Approval date [5]

23/08/2012

Ethics approval number [5]

LR97/1112

Ethics committee name [6]

Monash Health HREC

Ethics committee address [6]

Monash Health, Clayton, Melbourne

Ethics committee country [6]

Australia

Date submitted for ethics approval [6]

01/01/2012

Approval date [6]

25/05/2012

Ethics approval number [6]

12164Q

Ethics committee name [7]

Northern Health HREC

Ethics committee address [7]

Northern Hospital, Epping, Melbourne

Ethics committee country [7]

Australia

Date submitted for ethics approval [7]

01/01/2012

Approval date [7]

17/09/2012

Ethics approval number [7]

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

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

Dr Dr Mary White

Address

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

Australia

Phone

+61393455951

Email

[email protected]

Contact person for public queries

Name

Dr Mary White

Address

Department of Endocrinology & Diabetes,
Murdoch Children's Research Institute at The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052

Country

Australia

Phone

+61393455951

Email

[email protected]

Contact person for scientific queries

Name

Dr Mary White

Address

Department of Endocrinology & Diabetes,
Murdoch Children's Research Institute at The Royal Children's Hospital,
50 Flemington Road,
Parkville,
VIC 3052

Country

Australia

Phone

+61393455951

Email

[email protected]

Trial Review

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