Family Factors in Young People With Diabetes: a Qualitative Study

NCT ID: NCT04322071

Last Updated: 2020-03-26

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 16 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-26
• Study Completion Date: 2020-03-31

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.

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Lower risk of long term complications

Young people with diabetes who have HbA1c \<58mmols/mol, and family members.

Interview

Intervention Type: OTHER

Qualitative interviews only

Higher risk of long term complications

Young people with diabetes who have HbA1c ≥75mmols/mol and \<100mmols/mol, and family members.

Interview

Intervention Type: OTHER

Qualitative interviews only

Interventions

Interview

Qualitative interviews only

Intervention Type: OTHER

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

East Kent Hospitals University NHS Foundation Trust

OTHER_GOV

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anitha Kumaran, MBBS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southampton

Locations

East Kent Hospitals University Foundation NHS Trust

Ashford, Kent, United Kingdom

Countries

United Kingdom

Other Identifiers

52030

Identifier Type: -

Identifier Source: org_study_id