Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT06113588 |
| Other study ID # |
2022/ETH02412 |
| Secondary ID |
|
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 9, 2023 |
| Est. completion date |
June 9, 2028 |
Study information
| Verified date |
October 2023 |
| Source |
Northern Sydney and Central Coast Area Health Service |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
This research project seeks to address the question of how to improve the transition of
patients with type 1 diabetes mellitus from the paediatric to the adult health service at
RNSH and Mona Vale Community Health Centre (seeking the perspectives of patients, families,
and staff)?
Description:
There are significant limitations in the literature relating to transition from paediatric to
adult healthcare.
In healthcare, transition describes the purposeful process of planning and moving from
paediatric to adult services and usually occurs in adolescence (in itself a time of rapid
physical, cognitive and psychosocial growth between childhood and adulthood). The available
evidence within the literature to guide this process of transition is often limited and
additional evidence to guide clinical practice is required. Although reports within the
literature vary, it is known that up to 50% of young adults with an endocrine disorder are
lost to follow-up after transition to adult health services. Even if the young person attends
the adult service, they may have poor health outcomes related to inability to self-manage
their condition, particularly if it is a chronic disease requiring significant daily
intervention by the patient, such as in type 1 diabetes mellitus.
Type 1 diabetes mellitus is a life-long condition characterised by autoimmune-mediated
destruction of pancreatic β-cells, almost always resulting in absolute insulin deficiency. As
a result, patients are required to perform lifelong intensive glucose monitoring and insulin
administration. These intensive insulin regimens require an enormous amount of attention and
effort on the part of the young person with diabetes and their family, but dramatically
reduce their rates of micro- and macro-vascular complications, such as blindness, kidney
failure, heart attack and stroke. Evidence for this 'legacy effect' - the long-term clinical
benefits of early intensive insulin treatment - are provided through studies including the
EDIC (Epidemiology of Diabetes Interventions and Complications) study which undertook
long-term follow up of the Diabetes Control and Complications Trial (DCCT). The DCCT,
conducted from 1983-1989, randomised 1441 participants with new or recently-diagnosed type 1
diabetes to receive either intensive insulin therapy or standard therapy. The DCCT/EDIC study
ultimately recommended maintaining patients' glucose levels as close to the normal range as
safely possible, with intensive insulin therapy and monitoring.
Glycaemic control and transition in adolescents with type 1 diabetes mellitus has its own
specific challenges. Across all age groups, adolescents are currently the farthest from
achieving good glycaemic control (a HbA1c goal of <58 mmol/mol or 7.0%). The factors
contributing to this may include hormonal changes during puberty, psycho-social challenges
and decreased adherence to insulin therapy regimens.
Appropriate transition of patients with type 1 diabetes from paediatric to adult health care
thus needs to take a holistic approach to the individual patient which addresses these
factors and which is centred on individual patients' developmental stages and circumstances.
The local transition process at Royal North Shore Hospital has future potential At Royal
North Shore Hospital, there is a structured transition process underpinned by the transition
policy. However, initial analysis indicates that patients are missing appointments and
education, and being lost to follow-up. There is accordingly a pressing need for analysis of
the transition process and its outcomes.
Within the current literature, evaluation measures to assess patients' diabetes
self-management and transition readiness (including glucose monitoring, insulin and food
regulation, exercise, and emergency preparedness) frequently rely on patient self-report and
emphasise knowledge and practical skills in diabetes care.
This research will provide additional insights from the patient's family and from treating
staff as well as explore self-efficacy (the individual's belief in their capacity to execute
behaviours) which are often poorly studied in transition research. It is anticipated that
this will provide a comprehensive picture of areas in which patients' efficacy, transition
readiness, knowledge and diabetes-related distress can have tailored support provided in an
individualised way.
This research project will utilise the following questionnaires, with access for all
participants via a QR code using Northern Sydney Local Health District (NSLHD) REDCap (a
secure, web-based application for building and managing online surveys and databases).
1. A modified READDY tool assessing transition readiness and self-efficacy - with versions
that can be answered separately by the patient, the patient's family member, and the
patient's healthcare professional.
2. Diabetes knowledge questionnaire - with versions that can be answered separately by the
patient and patient's family member
3. Diabetes distress questionnaire - with versions that can be answered separately by the
patient and the patient's family member
4. Evaluation of the transition process - with versions that can be answered separately by
patient, patient's family member and staff member
