Type 1 DiabetesNCT04322071
Family Factors in Young People With Diabetes: a Qualitative Study
An observational study of Type 1 Diabetes, run by University of Southampton at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 12 to 15 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Interview
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 26 Feb 2020to 31 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 15 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
East Kent Hospitals University Foundation NHS Trust
Ashford, Kent, TN24 0LZ
About this study
Official title: 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.
Read the 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
- Being tested
- Interview
- Keywords
- Children and young people, Family, Qualitative
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterviewOther
Qualitative interviews only
| Study group | Role | What they receive |
|---|---|---|
| Lower risk of long term complications | Young people with diabetes who have HbA1c <58mmols/mol, and family members. Receives: Other: Interview | |
| Higher risk of long term complications | Young people with diabetes who have HbA1c ≥75mmols/mol and <100mmols/mol, and family members. Receives: Other: Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Interviews of up to 90mins conducted during the study period (a period of 5 weeks ending on the 31st of March 2020)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2020
- Study start26 Feb 2020
- Primary completion31 Mar 2020 (estimated)
- Study completion31 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- East Kent Hospitals University NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Anitha Kumaran, MBBS, PhD, Principal investigator, University of Southampton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04322071
- Sponsor's protocol ID
- 52030
- Status last verified
- Mar 2020
- First submitted
- 4 Mar 2020
- Last updated
- 26 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Diabetes Self-management in Young People and Their Families: a Qualitative Study
- ClinicalTrials.gov ID
- NCT04322071
- Acronym / sponsor ID
- 52030
- Conditions
- Type 1 Diabetes
- Keywords
- Children and young people, Family, Qualitative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- East Kent Hospitals University NHS Foundation Trust
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 31 Mar 2020 (estimated)
- Study completion
- 31 Mar 2020 (estimated)
- First posted
- 26 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower risk of long term complications | – | Other: InterviewYoung people with diabetes who have HbA1c <58mmols/mol, and family members. |
| Higher risk of long term complications | – | Other: InterviewYoung people with diabetes who have HbA1c ≥75mmols/mol and <100mmols/mol, and family members. |
Who may qualify
- Ages
- 12 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterviewQualitative interviews only | Other | Higher risk of long term complications, Lower risk of long term complications |
Primary outcome
Thematic Analysis
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anitha Kumaran, MBBS, PhD principal investigator
University of Southampton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by University of Southampton at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thematic Analysis (time frame: Interviews of up to 90mins conducted during the study period (a period of 5 weeks ending on the 31st of March 2020)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2020.