Trial ID: ISRCTN28944606
Other - Phase Unknown - No longer available
Background and study aims Traditional diabetes care methods may not be the most appropriate for supporting young adults’ self-management of type 1 diabetes (T1D). Previous research has shown that often during this period of transition, young adults are at a high risk of disengaging from services that no longer suit their needs. Since 2014, our research team and the Young Adult Panel (YAP) have worked together to develop a new intervention that can be used in clinic appointments. This intervention is called ‘D1 Now’. The aim of this study is to test if the D1 Now intervention could improve outcomes relating to diabetes and quality of life. Who can participate? Young adults aged 18-25 years who have had a definite diagnosis of T1D for more than 1 year What does the study involve? Intervention (or ‘D1 Now’) hospitals: If your hospital is one of those allocated to the intervention, you will be invited to take part in the D1 Now intervention for 1 year. Usual care hospitals: If your hospital is one of those allocated to usual care, you will continue with your routine diabetes service over 12 months. We will ask you to visit your local clinic lab and provide a blood sample for HBA1c measurement at the beginning and end of the study. We will ask you to fill in questionnaires on the physical, mental and financial aspects of having diabetes at the beginning and end of the study. After 12 months we will ask you to take part in a group or one-to-one interview about your experiences with either using the D1 Now intervention or usual diabetes care. D1 Now has two parts. 1. Agenda Setting Tool - a shared decision-making tool used by young adults and healthcare professionals to identify topics to discuss during clinic visits. 2. Support Worker - an advocate for young adults who is available at every clinic appointment and can be contacted in between appointments. What are the possible benefits and risks of participating? Taking part in this study may help young adults with type 1 diabetes (T1D) feel more supported in managing their condition. If your hospital is in the intervention group, you will have access to the D1 Now intervention, which includes an Agenda Setting Tool to help guide discussions during clinic visits and a Support Worker to offer additional support between appointments. This may improve how you engage with your diabetes care team and help tailor your clinic visits to focus on what matters most to you. Even if your hospital is in the usual care group, your participation will help improve diabetes care for young adults in the future. This study aims to make diabetes care more young-person-centred, and your input will help shape better healthcare experiences for people with T1D in the future. Risks: There are no major risks to taking part in this study. Providing a blood sample for HbA1c measurement is a routine procedure and may cause slight discomfort. Answering questionnaires or participating in interviews may take some time, and some questions about your diabetes experience might feel personal. However, you can skip any questions you are uncomfortable with. Your participation is completely voluntary, and you can withdraw at any time without affecting your diabetes care. Where is the study run from? The study is being run in 12 young adult diabetes clinics across the Island of Ireland. The coordinating centre is in the Clinical Research Facility Galway When is the study starting and how long is it expected to run for? February 2024 to October 2027 Who is funding the study? The Health Research Board (HRB) in Ireland through its Definitive Intervention and Feasibility Award scheme (DIFA-2023-018) Who is the main contact? D1 Now Programme manager (D1now@universityofgalway.ie)
Ollscoil na Gaillimhe – University of Galway
Source: https://www.isrctn.com/