Type 1 DiabetesNCT02422043
Description of Socio-cognitive and Clinic Changes for Type 1 Diabetes Adolescents Cohort With Therapeutic Patient Education Program
A study testing Questionnaires and audio-tape interviews in people with Type 1 Diabetes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
The patient education programs (TPEs) for the type 1 diabetic adolescents are designed to make the teenager to self manage their disease and its treatment. Based on social cognitive theory Bandura, the effects of educational activities for TVE should lead to the strengthening of self-efficacy, coupled with other… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Questionnaires and audio-tape interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2015to 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 12 and 17 inclusive; Type 1 diabetes diagnosis confirmed by a physician according to the diagnostic criteria (IDF \& ISPAD, 2011); Length of more than 6 months in the disease; Treatment with insulin for at least 6 months before the educational intervention; Inclusion in a TPE program "Pediatric Diabetes" allowed by the Regional Health Agency Mastery of the French language in written form (elementary level); Mastery of speaking the French language (elementary level); Consent signed by the holders of parental authority and adolescents.
Who cannot join
- Adolescents considered treatment failure, addressed to the SSR for intensive TPE inpatient program over a period of more than a month; Pregnant women, breast-feeding mothers (art L.1121-5 CSP). Persons deprived of their liberty by a judicial or administrative decision, those hospitalized without consent under Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research (art. L.1121-6 CSP) Major persons under a legal protection measure or unable to consent (Article L.1121-8 CSP).
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
The patient education programs (TPEs) for the type 1 diabetic adolescents are designed to make the teenager to self manage their disease and its treatment. Based on social cognitive theory Bandura, the effects of educational activities for TVE should lead to the strengthening of self-efficacy, coupled with other socio-cognitive factors favoring adherence of teenager and a better quality of life. However, socio-cognitive determinants and mechanisms to achieve this, implemented by adolescents during and after the ETP program, are not sufficiently documented.
Read the detailed description
Therapeutic patient education programs (TPE) to type 1 diabetic adolescents are designed to make the teenager to self manage their disease and their treatment. Based on Bandura's social cognitive theory, effects of educational activities for TPE should lead to the strengthening of self-efficacy, coupled with other socio-cognitive factors favoring adherence and a better quality of life for teenager. However, socio-cognitive determinants and mechanisms to achieve this, implemented by adolescents during and after the TPE program, are not sufficiently documented and French assessment tools are missing.
Objectives: The main objective of the research is to validate self-efficacy and adherence tools in French for type 1 diabetic teenagers, and secondarily, to describe evolution of a 3-month cohort of type 1 diabetes adolescents who took a TPE program on self-efficacy, quality of life, adherence, glycated hemoglobin (HbA1c) and socio-cognitive factors as Bandura's social cognitive theory and the study of possible links between these endpoints.
The participants of the prospective cohort of adolescents will be 12 to 17 years of age, type 1 diabetics with insulin, included in TPE program in one of two study areas. The number of subjects required was estimated to 80 patients. The process of cross-cultural adaptation tools will be through a linguistic and metrological validation. An integrated mixed method was used, consisting of three components:
- A quantitative before-after study: Collection and analysis of changes over 3 months of self-efficacy, adherence, quality of life and HbA1c (Student t test);
- A longitudinal qualitative study: interviews with 24 participants M0, M1 and M3 on the socio-cognitive factors according to Bandura (analysis continues theming)
- An integrative component: exploratory data analysis methods in order to link the evolution of treatment adherence and quality of life, with the evolution of self-efficacy and additional socio-cognitive factors.
Outcomes: This pilot research should validate the assessment tools and improve educational sessions for existing and future TPE programs, to type 1 diabetic teenagers to enhance their particular self-efficacy and to promote their independence and quality of life.
- Conditions
- Type 1 Diabetes
- Being tested
- Questionnaires and audio-tape interviews
- Keywords
- adolescence
- 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.
Questionnaires and audio-tape interviewsOther
therapeutic patient education programs (TPE) to type 1 diabetic adolescents are designed to make the teenager to self manage their disease and their treatment. Based on Bandura's social cognitive theory, effects of educational activities for TPE should lead to the strengthening of self-efficacy
| Study group | Role | What they receive |
|---|---|---|
| type 1 diabetes adolescents cohort | Experimental | The participants of the prospective cohort of adolescents will be 12 to 17 years of age, type 1 diabetics with insulin, included in TPE program Receives: Other: Questionnaires and audio-tape interviews |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-efficacy (Self-efficacy of Diabetes Management)
a10-items tools self-passation at M0-J2-M1 and M3
Measured: 3 months
Secondary outcomes (4)
Quality of life (KIDSCREEN-27)
a 27-items tools self-passation at M0-M1 and M3
Measured: 3 months
Adherence (Diabetes Self-Management Profile)
a 35-items tools, completed during interview with health professional at M0-J2-M1 and M3
Measured: 3 months
glycated hemoglobin (HbA1c)
Description: biological at M0 and M3
Measured: 3 months
socio-cognitive profile
interviews at M0-M1 and M3
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study start28 Jan 2015
- Primary completion15 Nov 2022
- 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 DiabetesStudies 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422043
- Sponsor's protocol ID
- 2014-28
- Status last verified
- Nov 2022
- First submitted
- 16 Apr 2015
- Last updated
- 17 Nov 2022
- Results posted
- No
- Data monitoring committee
- 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
- Description of Socio-cognitive and Clinic Changes for Type 1 Diabetes Adolescents Cohort With Therapeutic Patient Education Program
- ClinicalTrials.gov ID
- NCT02422043
- Acronym / sponsor ID
- 2014-28
- Conditions
- Type 1 Diabetes
- Keywords
- adolescence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 28 Jan 2015 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 21 Apr 2015 (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.
The patient education programs (TPEs) for the type 1 diabetic adolescents are designed to make the teenager to self manage their disease and its treatment. Based on social cognitive theory Bandura, the effects of educational activities for TVE should lead to the strengthening of self-efficacy, coupled with other socio-cognitive factors favoring adherence of teenager and a better quality of life. However, socio-cognitive determinants and mechanisms to achieve this, implemented by adolescents during and after the ETP program, are not sufficiently documented.
Detailed description
Therapeutic patient education programs (TPE) to type 1 diabetic adolescents are designed to make the teenager to self manage their disease and their treatment. Based on Bandura's social cognitive theory, effects of educational activities for TPE should lead to the strengthening of self-efficacy, coupled with other socio-cognitive factors favoring adherence and a better quality of life for teenager. However, socio-cognitive determinants and mechanisms to achieve this, implemented by adolescents during and after the TPE program, are not sufficiently documented and French assessment tools are missing.
Objectives: The main objective of the research is to validate self-efficacy and adherence tools in French for type 1 diabetic teenagers, and secondarily, to describe evolution of a 3-month cohort of type 1 diabetes adolescents who took a TPE program on self-efficacy, quality of life, adherence, glycated hemoglobin (HbA1c) and socio-cognitive factors as Bandura's social cognitive theory and the study of possible links between these endpoints.
The participants of the prospective cohort of adolescents will be 12 to 17 years of age, type 1 diabetics with insulin, included in TPE program in one of two study areas. The number of subjects required was estimated to 80 patients. The process of cross-cultural adaptation tools will be through a linguistic and metrological validation. An integrated mixed method was used, consisting of three components:
- A quantitative before-after study: Collection and analysis of changes over 3 months of self-efficacy, adherence, quality of life and HbA1c (Student t test);
- A longitudinal qualitative study: interviews with 24 participants M0, M1 and M3 on the socio-cognitive factors according to Bandura (analysis continues theming)
- An integrative component: exploratory data analysis methods in order to link the evolution of treatment adherence and quality of life, with the evolution of self-efficacy and additional socio-cognitive factors.
Outcomes: This pilot research should validate the assessment tools and improve educational sessions for existing and future TPE programs, to type 1 diabetic teenagers to enhance their particular self-efficacy and to promote their independence and quality of life.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| type 1 diabetes adolescents cohort | Experimental | Other: Questionnaires and audio-tape interviewsThe participants of the prospective cohort of adolescents will be 12 to 17 years of age, type 1 diabetics with insulin, included in TPE program |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Aged between 12 and 17 inclusive; Type 1 diabetes diagnosis confirmed by a physician according to the diagnostic criteria (IDF \& ISPAD, 2011); Length of more than 6 months in the disease; Treatment with insulin for at least 6 months before the educational intervention; Inclusion in a TPE program "Pediatric Diabetes" allowed by the Regional Health Agency Mastery of the French language in written form (elementary level); Mastery of speaking the French language (elementary level); Consent signed by the holders of parental authority and adolescents.
Key exclusion criteria (1 listed)
- Adolescents considered treatment failure, addressed to the SSR for intensive TPE inpatient program over a period of more than a month; Pregnant women, breast-feeding mothers (art L.1121-5 CSP). Persons deprived of their liberty by a judicial or administrative decision, those hospitalized without consent under Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8 and persons admitted to a health or social establishment for purposes other than research (art. L.1121-6 CSP) Major persons under a legal protection measure or unable to consent (Article L.1121-8 CSP).
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 |
|---|---|---|
| Questionnaires and audio-tape interviewstherapeutic patient education programs (TPE) to type 1 diabetic adolescents are designed to make the teenager to self manage their disease and their treatment. Based on Bandura's social cognitive theory, effects of educational activities for TPE should lead to the strengthening of self-efficacy | Other | type 1 diabetes adolescents cohort |
Primary outcome
self-efficacy (Self-efficacy of Diabetes Management)
Time frame: 3 months
a10-items tools self-passation at M0-J2-M1 and M3
4 secondary outcomes
Quality of life (KIDSCREEN-27)
Time frame: 3 months
Adherence (Diabetes Self-Management Profile)
Time frame: 3 months
glycated hemoglobin (HbA1c)
Time frame: 3 months
socio-cognitive profile
Time frame: 3 months
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.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaires and audio-tape interviews in people with Type 1 Diabetes, 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 1 inclusion and 1 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?
self-efficacy (Self-efficacy of Diabetes Management) (time frame: 3 months). 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.