Diversity in diabetes feasibility study

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The feasibility of sites appointing staff and training them to implement the study outcomes:
1. Sites are able to appoint Family Support Worker /Youth Worker (FSW/YW) and complete required training for them to deliver the intervention within a 12-month period
2. Number of Children and Young People with Type 1 diabetes (CYPD) recruited in relation to target recruitment. The aim is for 36 CYPD to be recruited over 8 weeks (approximately 18 from each site)
3. Number of CYPD engaging with the intervention after 6 months. The aim is that at least 80% of participants are still engaged with the intervention at 6 months after commencement. This will be assessed by the FSW/YW who, using an engagement template and activity log (provided by the study team), will class participant engagement as either ‘good’, ‘moderate’, or ‘poor’ (see below), with engagement being considered acceptable if ≥80% of participants are in the ‘good’ and ‘moderate’ categories.
Poor Engagement: Engaged in ≤20% of activities offered
Moderate Engagement: Engaged in 21 to 59% of activities offered
Good Engagement: Engaged in ≥60% of activities offered
4. Number of CYPD and families receiving each component of the intervention package. The aim is that at least 70% of CYPDs and their families received each relevant component of the intervention package (as identified at the outset by the FSW/YW together with CYPD and/or their families) and that at least 70% of CYPDs and their families receive the intervention as intended (measured by intervention delivery by the provider, and intervention engagement by participants, such as through attendance at intervention related activities such as support meetings). These will be recorded on an ongoing log and checked with the CYPD by the FSW/YW at the 3- and 6-month routine visits
5. Potential barriers for completion in the main study, identified by asking participating CYPD to complete the age-appropriate version of the Standard Version of the PedsQL™ - Pediatric Quality of Life Inventory™ Diabetes Module (v3.2). As underpowered, no formal statistical analysis will be undertaken on these data, which will not be carried across to the main trial
6. A selection of CYPD (including those who have withdrawn or declined their invitation to participate in the study), their parents/guardians, those recruiting and the healthcare professionals delivering the intervention and who have given consent to be contacted will be invited to be interviewed by a member of the research team either after they decline their invitation to join the study, or after their 6 months of additional support finishes, so that potential barriers can be identified and addressed prior to rolling out to the main study.

In addition, at the end of the intervention all participating CYPD and families will be given a postcard, displaying that CYPD's trial number. This postcard will display a short open question prompt, inviting free hand-written/drawn responses to the intervention (including drawings, thoughts or comments, and single words). Once completed the postcard will be placed into a provided prepaid envelope and returned directly to the research team.

A ‘digital postcard’ alternative will be offered to all participants who are in mobile phone contact with the Family Support Worker/Youth Worker or direct care team. Should the CYPD prefer this option then they will be invited to respond by text to the Family Support Worker/Youth Worker using a similar short open prompt, inviting short thoughts on/ responses to the intervention. Upon receipt the Family Support Worker/Youth Worker will transcribe the response, annotate it with the CYPD’s trial number and send it to the research team in Bristol via a secure method

Feedback from staff delivering the intervention, participants and carers to refine the intervention, collected using mixed methodology. For participants this will be after they exit the study when their 6 months of additional support finishes and will be undertaken by interview and written feedback via postcards and/or text messages. Staff who delivered the intervention will be interviewed at the end of a 12-month period to determine if they felt they had received sufficient training to deliver the intervention, what they felt about it, and what the barriers were to its delivery and how might these be overcome.