None listed
Conditions
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.
Interventions
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-sp
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.
Sponsors
Murdoch Children's Research Institute
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
17 Years to 19 Years
Healthy volunteers
No
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
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
Outcome results
None listed