Type 1 Diabetes in AdolescenceBADETNCT02859779
Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions
A study testing education programs in people with Type 1 Diabetes in Adolescence, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Background: In type 1 diabetes, adolescence is often associated with deterioration in glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to insulin. Read more about this study
- Who is it for?
- Ages 11 to 16 years
- Conditions the study is for
- Type 1 Diabetes in Adolescence
- What is being tested?
- education programs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2017to 15 Nov 2022
- Phase
- Interventional
- 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 11 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 11 and 16 years inclusive
- Type 1 diabetes diagnosis confirmed by a physician according to the diagnostic criteria
- Monitoring in the institutions participating in the research
- Speaking the French language (elementary level)
- Consent signed by the holders of the exercise of parental authority and the participant
Who cannot join
- Pregnant women, parturient women or breastfeeding mothers
- Persons deprived of liberty by a judicial or administrative decision
- Those hospitalized without consent under articles L. 3212-1 and L. 3213-1 that do not fall under the provisions of Article L. 1121-8
- Persons admitted in a health or social institution for purposes other than research (art. L.1121-6 health public code)
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital de la Timone Assistance Publique Hôpitaux de Marseille
Marseille, 13354
About this study
Official title: Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions: A Qualitative Study
Background: In type 1 diabetes, adolescence is often associated with deterioration in glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to insulin. Therapeutic patient education (TPE) is the key to successful management of the disease and treatment for adolescents with type 1 diabetes. Ten TPE programs exist in the Mediterranean region in France, and the care teams implementing them wish to promote joint reflection with sick teenagers and families to identify needs and expectations of everyone on priority skills to develop, to promote better management of the disease and improved quality of life.
Aim: To study the needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions, to promote self-management of their disease and their treatment.
Read more
Method: Four audio-recorded focus groups will be organized in all 10 clinical settings (adolescents, parents and health professionals). Thematic analysis will be carried out from the transcript of the focus groups.
Expected results: The results will allow a joint reflection involving the participation of young patients, families, health professionals and the research team to build and implement new educational sessions that meet the identified needs. This action resulting from the research is expected to pool resources in different health facilities providing therapeutic education programs and to harmonize practices.
- Conditions
- Type 1 Diabetes in Adolescence
- Being tested
- education programs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
education programsBehavioural
Four audio-recorded discussion groups will be organized in each of the 10 clinical settings
| Study group | Role | What they receive |
|---|---|---|
| mediterranean adolescents with type 1 diabetes | Other | Not described Receives: Behavioral: education programs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions
An interview guide was developed from the regulatory framework of therapeutic education in France, the theoretical framework of psychosocial skills in social psychology of health and from a previous experiment in the UK with diabetic children and their parents, to develop communication skills of health professionals (Hawthorne et al., 2011)
Measured: one day
Secondary outcomes (1)
Needs and expectations of parents of adolescents with type 1 diabetes for skills to be developed during the educational sessions
An interview guide was developed from the regulatory framework of therapeutic education in France, the theoretical framework of psychosocial skills in social psychology of health and from a previous experiment in the UK with diabetic children and their parents, to develop communication skills of health professionals (Hawthorne et al., 2011)
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2016 (estimated)
- Study start4 Feb 2017
- Primary completion12 Apr 2017
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes in AdolescenceStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02859779
- Sponsor's protocol ID
- 2015-36
- Acronym
- BADET
- Status last verified
- Nov 2022
- First submitted
- 1 Aug 2016
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Needs Assessment of Mediterranean Adolescents With Type 1 Diabetes About Therapeutic Education Sessions: A Qualitative Study
- ClinicalTrials.gov ID
- NCT02859779
- Acronym / sponsor ID
- BADET / 2015-36
- Conditions
- Type 1 Diabetes in Adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 4 Feb 2017 (actual)
- Primary completion
- 12 Apr 2017 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 9 Aug 2016 (estimated)
- 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.
Background: In type 1 diabetes, adolescence is often associated with deterioration in glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to insulin. Therapeutic patient education (TPE) is the key to successful management of the disease and treatment for adolescents with type 1 diabetes. Ten TPE programs exist in the Mediterranean region in France, and the care teams implementing them wish to promote joint reflection with sick teenagers and families to identify needs and expectations of everyone on priority skills to develop, to promote better management of the disease and improved quality of life.
Aim: To study the needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions, to promote self-management of their disease and their treatment.
Method: Four audio-recorded focus groups will be organized in all 10 clinical settings (adolescents, parents and health professionals). Thematic analysis will be carried out from the transcript of the focus groups.
Expected results: The results will allow a joint reflection involving the participation of young patients, families, health professionals and the research team to build and implement new educational sessions that meet the identified needs. This action resulting from the research is expected to pool resources in different health facilities providing therapeutic education programs and to harmonize practices.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| mediterranean adolescents with type 1 diabetes | Other | Behavioral: education programs |
Who may qualify
- Ages
- 11 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged between 11 and 16 years inclusive
- Type 1 diabetes diagnosis confirmed by a physician according to the diagnostic criteria
- Monitoring in the institutions participating in the research
- Speaking the French language (elementary level)
- Consent signed by the holders of the exercise of parental authority and the participant
Key exclusion criteria (4 listed)
- Pregnant women, parturient women or breastfeeding mothers
- Persons deprived of liberty by a judicial or administrative decision
- Those hospitalized without consent under articles L. 3212-1 and L. 3213-1 that do not fall under the provisions of Article L. 1121-8
- Persons admitted in a health or social institution for purposes other than research (art. L.1121-6 health public code)
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 |
|---|---|---|
| education programsFour audio-recorded discussion groups will be organized in each of the 10 clinical settings | Behavioural | mediterranean adolescents with type 1 diabetes |
Primary outcome
Needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions
Time frame: one day
An interview guide was developed from the regulatory framework of therapeutic education in France, the theoretical framework of psychosocial skills in social psychology of health and from a previous experiment in the UK with diabetic children and their parents, to develop communication skills of health professionals (Hawthorne et al., 2011)
1 secondary outcome
Needs and expectations of parents of adolescents with type 1 diabetes for skills to be developed during the educational sessions
Time frame: one day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing education programs in people with Type 1 Diabetes in Adolescence, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
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 4 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: finished, as of the sponsor's last update on 17 Nov 2022. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions (time frame: one day). 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 17 Nov 2022.