Family Factors in Young People With Diabetes: a Qualitative Study

NCT04322071 | Unknown

• 1 other identifier: 52030
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Children and young people; Family; Qualitative

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Lower risk of long term complications

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

Other: Interview

Higher risk of long term complications

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

Other: Interview

Interventions

Interview OTHER

Qualitative interviews only

Higher risk of long term complications; Lower risk of long term complications

Eligibility Criteria

• Age: 12 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southampton: lead
• East Kent Hospitals University NHS Foundation Trust: collaborator

Study Sites (1)

East Kent Hospitals University Foundation NHS Trust

Ashford, Kent, TN24 0LZ, United Kingdom

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Interviews as Topic

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Anitha Kumaran, MBBS, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2020
• First Posted: March 26, 2020
• Study Start: February 26, 2020
• Primary Completion: March 31, 2020
• Study Completion: March 31, 2020
• Last Updated: March 26, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)