Background
Young adults living with type 1 diabetes (T1D) are at risk of lower engagement with self-management and poorer clinical and psychosocial outcomes in comparison to younger and older people with diabetes. Young adulthood is a challenging time in the lifecourse, with many pressures and changing roles and responsibilities. Balancing the management of a complex chronic condition with the demands and unpredictability of young adulthood can be difficult.
Since 2014 our multi-disciplinary team (including our PPI panel of young adults living with diabetes called the Young Adult Panel or YAP) has been working to develop, refine, feasibility test and pilot a complex intervention called D1 Now. Results from the pilot trial confirm that a definitive randomised controlled trial (RCT) is feasible and that a modified version of the intervention is feasible and acceptable to patients and healthcare professionals. The current D1 Now intervention is delivered alongside usual care and consists of two components: a Support Worker and an Agenda Setting Tool.
Aim
To determine whether the D1 Now intervention, when compared to usual care is effective and cost-effective in improving patient outcomes (HbA1c, episodes of ketoacidosis, episodes of severe hypoglycaemia, clinic attendance, diabetes distress, diabetes self-management, perceived level of control over diabetes and diabetes related quality of life).
Methods
We will deliver a cluster RCT of the D1 Now intervention. The primary outcome will be change in HbA1c between baseline and 12 follow-up. We estimate that we need a sample size of 250 patients from 10 centres to detect a minimum clinically important difference between arms of 5.0 mmol/mol using an ANCOVA mixed model and 90% power. To allow for attrition of one centre per arm, we will recruit 12 centres into the trial, 6 each in the intervention and control arms. To allow for 15% attrition in young adult participants, we will recruit 348 young adults (29 in each of 12 centres). We will embed a qualitative study, an economic analysis, fidelity assessment and SWAT into the study protocol.
Dissemination and impact
We will develop a YAP-led dissemination strategy to ensure translation of findings into practice and policy.
