Family Factors in Young People With Diabetes: a Qualitative Study

Type 1 Diabetes Clinical Trial

Official title:

Factors Affecting Diabetes Self-management in Young People and Their Families: a Qualitative Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04322071
• Other study ID #: 52030
• Status: Enrolling by invitation
• Start date: February 26, 2020
• Est. completion date: March 31, 2020

Study information

• Verified date: March 2020
• Source: University of Southampton
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 16
• Est. completion date: March 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Type 1 Diabetes

Intervention

Other:
• Interview
Qualitative interviews only

Locations

Country	Name	City	State
United Kingdom	East Kent Hospitals University Foundation NHS Trust	Ashford	Kent

Sponsors (2)

Lead Sponsor	Collaborator
University of Southampton	East Kent Hospitals University NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

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