Family Factors in Young People With Diabetes: a Qualitative Study

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

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.

Study Overview

• Status: Unknown
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Other: Interview

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 Type: Observational
• Enrollment (Anticipated): 16

Contacts and Locations

Study Locations

• United Kingdom
  • Kent
    • Ashford, Kent, United Kingdom, TN24 0LZ
      • East Kent Hospitals University Foundation NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Lower risk of long term complications; Young people with diabetes who have HbA1c <58mmols/mol, and family members.	Other: Interview; Qualitative interviews only
Higher risk of long term complications; Young people with diabetes who have HbA1c ≥75mmols/mol and <100mmols/mol, and family members.	Other: Interview; Qualitative interviews only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of Southampton
• Collaborators: East Kent Hospitals University NHS Foundation Trust
• Investigators: Principal Investigator: Anitha Kumaran, MBBS, PhD, University of Southampton

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): March 31, 2020

Study Registration Dates

• First Submitted: March 4, 2020
• First Submitted That Met QC Criteria: March 23, 2020
• First Posted (Actual): March 26, 2020

Study Record Updates

• Last Update Posted (Actual): March 26, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Family; Children and young people; Qualitative
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 52030

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No