Family Factors in Young People With Diabetes: a Qualitative Study

Sponsor
University of Southampton (Other)
Overall Status
Unknown status
CT.gov ID
NCT04322071
Collaborator
East Kent Hospitals University NHS Foundation Trust (Other)
16
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1.1
14.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
16 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Factors Affecting Diabetes Self-management in Young People and Their Families: a Qualitative Study
Actual Study Start Date :
Feb 26, 2020
Anticipated Primary Completion Date :
Mar 31, 2020
Anticipated Study Completion Date :
Mar 31, 2020

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
12 Years to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 East Kent Hospitals University Foundation NHS Trust Ashford Kent United Kingdom TN24 0LZ

Sponsors and Collaborators

  • University of Southampton
  • East Kent Hospitals University NHS Foundation Trust

Investigators

  • Principal Investigator: Anitha Kumaran, MBBS, PhD, University of Southampton

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Southampton
ClinicalTrials.gov Identifier:
NCT04322071
Other Study ID Numbers:
  • 52030
First Posted:
Mar 26, 2020
Last Update Posted:
Mar 26, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by University of Southampton
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 26, 2020