Type 1 Pediatric DiabetesETPACAPNCT02859818
Description of the Evolution of a Cohort of Adolescents With Type 1 Diabetes Following Their Participation in Therapeutic Education Program Based on Social Cognitive Theory: Socio-cognitive Profile, Physiological Behaviour of Therapeutic Adherence and Quality of Life
A study testing therapeutic education program in people with Type 1 Pediatric Diabetes, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
Introduction: Therapeutic Patient Education (TPE) is the key of the interdisciplinary management of type 1 diabetes for adolescents, favoring their adherence and improving their quality of life and metabolic control. Read more about this study
- Who is it for?
- Ages 11 to 17 years
- Conditions the study is for
- Type 1 Pediatric Diabetes
- What is being tested?
- therapeutic education program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2016to May 2020
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Aged between 11 and 17 years inclusive;
- Type 1 diabetes diagnosis confirmed by a doctor according to the diagnostic criteria;
- More than 6 months in the disease;
- Treatment with insulin for at least 6 months before the educational intervention;
- Mastery of the French language written (elementary level)
- Fluency in speaking the French language (elementary level)
- Consent signed by the holders of parental authority and adolescents.
Who cannot join
- Pregnant women, parturient women or breastfeeding mothers (Article L.1121-5 of the Code of Public Health.)
- 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 of the Code of Public Health
Trial locations and contacts
1 site in 1 country.
France1 site
Assistance Publique Hôpitaux de Marseille
Marseille, 13354
Sébastien COLSON, 0491383267, sebastien.colson@ap-hm.fr
About this study
Introduction: Therapeutic Patient Education (TPE) is the key of the interdisciplinary management of type 1 diabetes for adolescents, favoring their adherence and improving their quality of life and metabolic control. Six pediatric diabetes teams have engaged in action research to build a regional ETP program based on social cognitive theory of Bandura, assuming that the learning strategies of theory, applied in ETP program, should strengthen self-efficacy of adolescents with type 1 diabetes, which could induce an improvement behaviors adherence, quality of life and physiological profile of participants about 6 months post-inclusion in the program.
Aims: The main objective is to describe the evolution over 6 months of self-efficacy in a cohort of adolescents with type 1 diabetes who followed a therapeutic education program based on social cognitive theory of Bandura in region PACA (ETPACAP program). Secondary objectives are to describe the evolution of 6 months of glycemic control, behavior of adherence, quality of life and other components of social cognitive theory for this population, to explore the effects of socio-cognitive profile on adherence, quality of life and glycemic control among adolescents with type 1 diabetes followed this program.
Read more
Method: A prospective multicenter cohort study of adolescents with type 1 diabetes who participated in ETPACAP program, consisting of three components:
- A quantitative component: collection and analysis of changes over 6 months of self-efficacy, adherence, quality of life and HbA1c levels (ANOVA repeated measures);
- A qualitative component: interviews with 32 participants at M0, M3 and M6 on the socio-cognitive factors according to Bandura (analysis continues theming);
- An integrative component, exploring the effects of the components of social cognitive theory on adherence, glycemic control and quality of life of adolescents with type 1 diabetes cohort.
Expected results: This research is expected to bring new knowledge about the ETP programs and the adolescent cohort studied to make an improvement and adjustment of educational sessions relevant to the needs and expectations of this population.
- Conditions
- Type 1 Pediatric Diabetes
- Being tested
- therapeutic education program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic education programOther
| Study group | Role | What they receive |
|---|---|---|
| adolescents with type 1 diabetes | Other | adolescents with type 1 diabetes following their participation in therapeutic education program Receives: Other: therapeutic education program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy evaluated with the 10 items-SEDM
The self-efficacy will be evaluated with the 10 items-SEDM (Iannotti et al., 2006), translated into French by an adaptation process cross-cultural (linguistic validation and metrology)
Measured: 6 months
Secondary outcomes (4)
Adherence will be evaluated using 'the Diabetes Self-Management Profile "tool (DSMP)
Adherence will be evaluated using 'the Diabetes Self-Management Profile "tool (DSMP) (Schneider et al., 2007; Iannotti et al, 2006, Harris et al, 2000), translated into french through a process of adaptation-cultural (linguistic and metrological validation)
Measured: 6 months
Quality of life will be assessed using the KIDSCREEN-27
The quality of life will be assessed using the KIDSCREEN-27 (v 8-18 years) (Robitail et al., 2007). The KIDSCREEN is a self-administered generic questionnaire developed and validated as part of a European research project with children and adolescents (Kidscreen Group, 2006)
Measured: 6 months
Glycemic control: glycated hemoglobin (HbA1c)
The glycated hemoglobin (HbA1c) in rising every medical visit (ISPAD, 2011)
Measured: 6 months
Outcome expectations, socio-structural factors and personal goals
An individual semi-structured interview and audio-recorded will be led by a social health psychologist. The duration will not exceed 45 minutes. Identification of the participant in the qualitative component will link data from the interview with the collected quantitative data.
Measured: 6 months
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 startDec 2016
- Primary completionDec 2019 (estimated)
- Study completionMay 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 Pediatric 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 168 participants (estimated)
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
- NCT02859818
- Sponsor's protocol ID
- RCAPHM15_0120
- Acronym
- ETPACAP
- Status last verified
- Aug 2016
- First submitted
- 1 Aug 2016
- Last updated
- 9 Aug 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Description of the Evolution of a Cohort of Adolescents With Type 1 Diabetes Following Their Participation in Therapeutic Education Program Based on Social Cognitive Theory: Socio-cognitive Profile, Physiological Behaviour of Therapeutic Adherence and Quality of Life
- ClinicalTrials.gov ID
- NCT02859818
- Acronym / sponsor ID
- ETPACAP / RCAPHM15_0120
- Conditions
- Type 1 Pediatric Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2019 (estimated)
- Study completion
- May 2020 (estimated)
- 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.
Introduction: Therapeutic Patient Education (TPE) is the key of the interdisciplinary management of type 1 diabetes for adolescents, favoring their adherence and improving their quality of life and metabolic control. Six pediatric diabetes teams have engaged in action research to build a regional ETP program based on social cognitive theory of Bandura, assuming that the learning strategies of theory, applied in ETP program, should strengthen self-efficacy of adolescents with type 1 diabetes, which could induce an improvement behaviors adherence, quality of life and physiological profile of participants about 6 months post-inclusion in the program.
Aims: The main objective is to describe the evolution over 6 months of self-efficacy in a cohort of adolescents with type 1 diabetes who followed a therapeutic education program based on social cognitive theory of Bandura in region PACA (ETPACAP program). Secondary objectives are to describe the evolution of 6 months of glycemic control, behavior of adherence, quality of life and other components of social cognitive theory for this population, to explore the effects of socio-cognitive profile on adherence, quality of life and glycemic control among adolescents with type 1 diabetes followed this program.
Method: A prospective multicenter cohort study of adolescents with type 1 diabetes who participated in ETPACAP program, consisting of three components:
- A quantitative component: collection and analysis of changes over 6 months of self-efficacy, adherence, quality of life and HbA1c levels (ANOVA repeated measures);
- A qualitative component: interviews with 32 participants at M0, M3 and M6 on the socio-cognitive factors according to Bandura (analysis continues theming);
- An integrative component, exploring the effects of the components of social cognitive theory on adherence, glycemic control and quality of life of adolescents with type 1 diabetes cohort.
Expected results: This research is expected to bring new knowledge about the ETP programs and the adolescent cohort studied to make an improvement and adjustment of educational sessions relevant to the needs and expectations of this population.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adolescents with type 1 diabetes | Other | Other: therapeutic education programadolescents with type 1 diabetes following their participation in therapeutic education program |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Aged between 11 and 17 years inclusive;
- Type 1 diabetes diagnosis confirmed by a doctor according to the diagnostic criteria;
- More than 6 months in the disease;
- Treatment with insulin for at least 6 months before the educational intervention;
- Mastery of the French language written (elementary level)
Key exclusion criteria (2 listed)
- Pregnant women, parturient women or breastfeeding mothers (Article L.1121-5 of the Code of Public Health.)
- 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 of the Code of Public Health
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 |
|---|---|---|
| therapeutic education program | Other | adolescents with type 1 diabetes |
Primary outcome
Self-efficacy evaluated with the 10 items-SEDM
Time frame: 6 months
The self-efficacy will be evaluated with the 10 items-SEDM (Iannotti et al., 2006), translated into French by an adaptation process cross-cultural (linguistic validation and metrology)
4 secondary outcomes
Adherence will be evaluated using 'the Diabetes Self-Management Profile "tool (DSMP)
Time frame: 6 months
Quality of life will be assessed using the KIDSCREEN-27
Time frame: 6 months
Glycemic control: glycated hemoglobin (HbA1c)
Time frame: 6 months
Outcome expectations, socio-structural factors and personal goals
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2016.
Related trials for Type 1 Pediatric Diabetes
Not yet recruiting
A Novel Miniature Equine-Assisted Diabetes Education Program for Youth: Evaluating the Diabetes Equine Empowerment Program (DEEP).
Diabetes (Insulin-requiring, Type 1 or Type 2), Pediatric Diabetes
Enrolling by invitationObservational study
Universal Type 1 Diabetes Screening in Pediatrics
Type 1 Diabetes (T1D)
Recruiting
The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment
Type 1 Diabetes
RecruitingPhase 2
Efficacy and Safety of Teplizumab in Japanese Participants With Stage 2 Type 1 Diabetes
Type 1 Diabetes Mellitus
Active, not recruiting
Support-t Online Training in Youth Living With Type 1 Diabetes Transitioning to Adult Care
Diabetes Mellitus, Diabetes Mellitus, Type 1
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 therapeutic education program in people with Type 1 Pediatric 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 7 inclusion and 2 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 9 Aug 2016. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sébastien COLSON (0491383267, sebastien.colson@ap-hm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy evaluated with the 10 items-SEDM (time frame: 6 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 9 Aug 2016.