Type 1 diabetes (children and young people) Nutritional, Metabolic, Endocrine
Conditions
Interventions
A bespoke package of interventions including:
1. Peer support
2. Life-coaching
3. Family support worker or Youth Worker input
4. Enhanced supportive ethos from the children’s diabetes clinic
Those
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Carer willing to consent and participant to assent (if the participant is aged under 16 completed years or lacks the capacity to consent themselves) or participant willing and able to consent (aged 16 years and over) AND If white UK ethnicity: 1. Clinical diagnosis of type 1 diabetes of more than 12 months 2. Age 5-19 completed years at the time of commencement of the enrollment 3. Resident in index of multiple deprivation area deciles 1 and 2 4. Recipient of free school meals OR If UK minority ethnicity, other than white: 1, Clinical diagnosis of type 1 diabetes of more than 12 months 2. Age 5-19 completed years at the time of commencement of the intervention
Exclusion criteria
Exclusion criteria: 1. Diagnosis of other forms of diabetes (type 2, monogenic, secondary diabetes) 2. Psychiatric disorder that in the opinion of the local investigator might affect compliance with study procedures 3. Significant other chronic illness in addition to diabetes that may confound the results of the intervention 4. Participated in diabetes treatment trials in the 12 months prior to collection of baseline data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
England, United Kingdom
Contacts
Public ContactTim Barrett
Outcome results
None listed