Family Factors in Young People With Diabetes: a Qualitative Study

• Conditions: Type 1 Diabetes
• Interventions: Other: Interview

• Registration Number: NCT04322071
• Lead Sponsor: University of Southampton

Brief Summary

8 young people (aged 12-15yrs) with type 1 diabetes will be interviewed along with their families during this qualitative study. The interviews will explore factors identified by the young people and their families as important in diabetes management. Comparison of these factors will then be made between the young people with higher and lower HbA1c levels.

Detailed Description

Family is an important factor in the self-management of type 1 diabetes by children and young people. Existing research has explored the experience of living with diabetes, considered from the perspective of children and parents, but has not provided children's diabetes teams with the information they need to support young people with higher blood glucose levels, and therefore higher risks of long term complications related to their diabetes.

During this qualitative study the researcher will meet with young people (aged 12-15yrs) and their families for a joint interview, held in the family home, exploring the factors which they consider important in diabetes self-management.

One interview will be held with each family. Recruitment of 8 families is planned.

The interviews will be recorded and transcribed to allow thematic analysis, allowing identification of common factors considered to be important by families.

The HbA1c of young people with diabetes is checked regularly in clinic and provides an assessment of blood glucose levels over the preceding months. Higher HbA1c levels are associated with higher risk of long term complications.

The index young people will be recruited in 2 groups: one group will have lower risk of long term complications (identified by an HbA1c level of \<58mmol/mol). The other will have higher risk (HbA1c 75-100mmol/mol). A comparison will be made between the families in each group, to identify which themes are more common in the lower or higher risk groups.

Study Timeline

• Study Start: 2020-02-26
• Status Verified: 2020-03
• Study First Submitted: 2020-03-04
• Study First Submitted QC: 2020-03-23
• Last Update Submitted: 2020-03-23
• Study First Posted: 2020-03-26
• Last Update Posted: 2020-03-26
• Primary Completion: 2020-03-31
• Study Completion: 2020-03-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Age 12 - 15 years (between their 12th and 16th birthday at recruitment)
• Type 1 diabetes diagnosed for at least 6 months
• Group 1: HbA1c <58mmols/mol on last known test
• Group 2: HbA1c ≥75mmols/mol and <100mmols/mol on last known test
• Willing to participate in group interview with at least one parent/carer

Exclusion Criteria

• Family currently identified as not suitable for lone visits
• Participants with inadequate English to take part in a semi-structured interview conducted in English
• Children and Young people for whom the last HbA1c incongruent with their previous results will be excluded

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Higher risk of long term complications	Interview	Young people with diabetes who have HbA1c ≥75mmols/mol and \<100mmols/mol, and family members.
Lower risk of long term complications	Interview	Young people with diabetes who have HbA1c \<58mmols/mol, and family members.

Primary Outcome Measures

Name	Time	Method
Thematic Analysis	Interviews of up to 90mins conducted during the study period (a period of 5 weeks ending on the 31st of March 2020)	Themes identified against the primary question: what factors do families identify as important in self-management of a young person's Type 1 diabetes

Trial Locations

Locations (1)

East Kent Hospitals University Foundation NHS Trust; 🇬🇧 Ashford, Kent, United Kingdom