Clinical trial NCT04322071: Family Factors in Young People With Diabetes: a Qualitative Study
Official title: Factors Affecting Diabetes Self-management in Young People and Their Families: a Qualitative Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Type 1 Diabetes
Keywords: Children and young people
Family
Qualitative
Lead sponsor: University of Southampton
Sponsor class: OTHER
Collaborators: name: East Kent Hospitals University NHS Foundation Trust
First posted: 2020-03-26
Enrollment: 16
Sex: ALL
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young people aged 12-15yrs with HbA1c in one of the two groups (4 from each group) will be identified from the caseload of the East Kent Children's Diabetes Team. They will be invited to participate in interviews along with at least one parent/carer, and up to 4 other people (including children) which they identify as important in their diabetes management.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Thematic Analysis
timeFrame: Interviews of up to 90mins conducted during the study period (a period of 5 weeks ending on the 31st of March 2020)
Secondary outcomes:
Other outcomes:
Locations:
city: Ashford
country: United Kingdom
facility: East Kent Hospitals University Foundation NHS Trust
state: Kent
Study officials:
affiliation: University of Southampton
name: Anitha Kumaran, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References: