Účinnost televýživy pro léčbu pacientů s nadváhou a obezitou a/nebo vysokým kardiometabolickým rizikem (TOOLBAR)
Účinnost televýživy (OBE-COACH) pro léčbu pacientů s nadváhou a obezitou a/nebo vysokým kardiometabolickým rizikem
The OBE-COACH program is an automated online nutritional coaching service that was evaluated in its first version (MXS-CARE program) in a clinical trial coordinated by our team, in type 2 diabetic patients with abdominal obesity. Results have confirmed the efficiency of the program to improve lifestyle habits, including the 4-month diet, and to reduce weight and HbA1c levels.
Based on our experience and the scientific literature, the investigators assume that adherence to the program may diminish in the long term to the point of calling into question its efficiency. So IRIADE compagny developed an enhanced program called OBE-COACH. The OBE-COACH program has been specifically designed to facilitate long-term user adherence. The OBE-COACH program, integrates a bidirectional interactive link between the patient and an automated support system (IRIADE-MED system) associated with an inexpensive remote human support.
In the TOOLBAR study, the investigators will evaluate the efficiency of the OBE-COACH solution in a population of obese patients or overweight persons with at least one cardiometabolic risk factor.
A group of patients will have access to the OBE-COACH program. It will be compared to a control group which will receive an e-learning program with free access to advice sheets via the web, to a menu generator, videos and a catalog of physical activity, (resources made available by the web site www.mangerbouger.fr (public health France, ministry in charge of health) . Indeed, the investigators judged that the loss of patients during follow-up would be greater if e-learning was not offered in the control group.
Přehled studie
Postavení
Podmínky
Detailní popis
The management of patients in the TOOLBAR study will be in accordance with French recommendations: a patient who is overweight should benefit from a dietary, physical activity, psychological assistance and medical monitoring advices which can be provided by a general practitioner. In the control group, subjects have access to an e-learning program, including free access via the web to a nutritional information portal and to automated tools providing information and advice for adopting a balanced, low-carb diet and to practice physical activity in line with the guidelines of the national health nutrition plan (PNNS). However, this group will not have access to the OBE-COACH program. The usual follow-up with the attending doctor will be continued.
Patients will be assessed at baseline, 6 months and 12 months. In an ancillary study they could be also assessed at 24 months.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Paris, Francie, 75013
- Hôpital La Pitié Salpêtrière
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Men or women 18 to 75 years
- Obesity defined by a body mass index > 30 kg / m2 or a BMI> 25 kg / m2 with the presence of at least one major cardiometabolic risk factors among the followings: dyslipidemia, hypertension, diabetes, prediabetes
- Stable weight in the last six months (weight variation < 4 kg peak-to-peak)
- Access and current use of internet, possession of an email address and a smartphone.
- Understanding and reading French
- Patient not currently following a nutritional monitoring and not having planned to be engaged in a nutritional monitoring during the coming year
Exclusion Criteria:
- Excessive alcohol consumption > 30 g / day -Pregnant or breastfeeding woman
- symptomatic cardiovascular disease : angina, lower extremity arterial occlusive disease, stroke or myocardial infarction dating of less than 6 months.
- Uncontrolled psychiatric illness
- Patients receiving or about to receive during the study period a systemic or local treatment susceptible to interfere with the evaluation of the primary criteria (corticosteroids, antipsychotics, tricyclic antidepressants) except if these treatments have been stable for at least 6 months without a plan to modify the dose during the 12 months of the study
- Adhering to a prescribed diet for weight loss, in the past 3 months
- Person with a severe eating disorder: bulimia, binge eating disorder according to DSM-V criteria - Presence of celiac disease, Crohn's disease or other metabolic disorder or condition affecting nutritional needs such as allergies or food intolerances (except partial lactose intolerance)
- Anticipated difficulties in following the patient
- Lack of social coverage in France
- Lack of written or electronic informed consent
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: OBE-COACH program
The OBE-COACH experimental group: access to the complete OBE-COACH program |
OBE-COACH works through private exchanges between the user and an automatic generator of recommendations, advice and messages of encouragement. Web focus groups are propoposed by specialist to respond to the questions of the participants and a tele-interview at 6 months with a dietetician to encourage and assist the patient to make the best use of the program. The program is divided into missions to perform. These missions are grouped into 10 families. The completion of each mission and the correct answers to the quiz offer points and bonuses. To promote better adherence to the program, missions are not repetitive. They are proposed to surprise the user and constantly renew his desire to connect to the program and achieve goals. The intensity level of the program is selected by the user at any time. Connected devices provide to patient are auto-tensiometer and balance. These devices will not be connected to the OBE-COACH program. The auto-tensiometer (Tensio-screen, Terraillon) is a connected tensiometer allowing the patient to measure by himself with an armband his systolic and diastolic blood pressure and his heart rate. The balance (Web coach premium, Terraillon) is a connected scale to collect body weight. The Activity Tracer (activi-T band, Terraillon) is a a wristband connected activity tracer worn on the wrist that tracks the patient's physical activity and calculates the number of steps, distance traveled and calories burned. The Activity Tracer will not be connected to the OBE-COACH program. |
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Aktivní komparátor: e-learning program
The control group: access to an e-learning program with free access via the web to advice sheets, a menu generator and a catalog of physical activity (resources made available by the site www.mangerbouger.fr ; Public Health France, Ministry of Health) and provision of connected devices (auto-tensiometer and balance). |
Connected devices provide to patient are auto-tensiometer and balance. These devices will not be connected to the OBE-COACH program. The auto-tensiometer (Tensio-screen, Terraillon) is a connected tensiometer allowing the patient to measure by himself with an armband his systolic and diastolic blood pressure and his heart rate. The balance (Web coach premium, Terraillon) is a connected scale to collect body weight. The Activity Tracer (activi-T band, Terraillon) is a a wristband connected activity tracer worn on the wrist that tracks the patient's physical activity and calculates the number of steps, distance traveled and calories burned. The Activity Tracer will not be connected to the OBE-COACH program. e-learning program with free access via the web to advice sheets, a menu generator and a catalog of physical activity (resources made available by the site www.mangerbouger.fr ; Public Health France, Ministry of Health) |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Weight reduction of at least 5% between 0 and 12 months.
Časové okno: 12 months
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Weight reduction of at least 5% between 0 and 12 months. The weight, in Kg, will be measured in a state of fastness ≥ 8h, in participants wearing light clothing without shoes on the same scales calibrated at inclusion and 12 months of follow-up. |
12 months
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Změna mezi 0 a 12 měsíci příjmu bílkovin v g/den, hodnocená validovaným dotazníkem NAQA
Časové okno: 12 měsíců
|
12 měsíců
|
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Změna mezi 0 a 12 měsíci příjmu sacharózy v g/den, hodnocená validovaným dotazníkem NAQA
Časové okno: 12 měsíců
|
12 měsíců
|
|
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Změna mezi 0 a 12 měsíci příjmu lipidů v g/den, hodnocená validovaným dotazníkem NAQA
Časové okno: 12 měsíců
|
12 měsíců
|
|
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Změna mezi 0 a 12 měsíci příjmu vápníku v mg/den, hodnocená validovaným dotazníkem NAQA
Časové okno: 12 měsíců
|
12 měsíců
|
|
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Změna mezi 0 a 12 měsíci spotřeby slazených nápojů v počtu sklenic/den
Časové okno: 12 měsíců
|
12 měsíců
|
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Změna mezi 0 a 12 měsíci konzumace alkoholických nápojů v počtu sklenic/den
Časové okno: 12 měsíců
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12 měsíců
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Změna mezi 0 a 6 měsíci spotřeby slazených nápojů v počtu sklenic/den
Časové okno: 6 měsíců
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6 měsíců
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Změna mezi 0 a 6 měsíci konzumace alkoholických nápojů v počtu sklenic/den
Časové okno: 6 měsíců
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6 měsíců
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Změna mezi 0 a 12 měsíci spotřeby tabáku v počtu cigaret/den
Časové okno: 12 měsíců
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12 měsíců
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Změna mezi 0 a 6 měsíci spotřeby tabáku v počtu cigaret/den
Časové okno: 6 měsíců
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6 měsíců
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Změna mezi 0 a 12 měsíci Dodržování doporučení WHO pro fyzickou aktivitu, měřeno v Metabolic Equivalent of Task, MET, hodnoceno pomocí dotazníku GPAQ.
Časové okno: 12 měsíců
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12 měsíců
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Změna mezi 0 a 6 měsíci Dodržování doporučení WHO pro fyzickou aktivitu, měřeno v Metabolic Equivalent of Task, MET, hodnoceno pomocí dotazníku GPAQ.
Časové okno: 6 měsíců
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6 měsíců
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Dodržování programu OBE-COACH po 12 měsících, hodnoceno průměrným procentem otázek (zaslaných IRIADE) s odpověďmi od subjektu za týden během předchozího měsíce.
Časové okno: 12 měsíců
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12 měsíců
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Dodržování programu OBE-COACH po 12 měsících, hodnoceno podle počtu účastí ve webových fokusních skupinách za posledních 6 měsíců.
Časové okno: 12 měsíců
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12 měsíců
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Dodržování programu OBE-COACH po 6 měsících, hodnoceno průměrným procentem otázek (zaslaných IRIADE) s odpověďmi od subjektu za týden během předchozího měsíce.
Časové okno: 6 měsíců
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6 měsíců
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Dodržování programu OBE-COACH po 6 měsících, hodnoceno podle počtu účastí ve webových fokusních skupinách za posledních 6 měsíců.
Časové okno: 6 měsíců
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6 měsíců
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Změna mezi 0 a 12 měsíci potravinové impulzivity hodnocená dotazníkem TFEQ21
Časové okno: 12 měsíců
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12 měsíců
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Změna mezi 0 a 6 měsíci potravinové impulzivity hodnocená dotazníkem TFEQ21
Časové okno: 6 měsíců
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6 měsíců
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Vývoj symptomů úzkosti mezi 0 a 12 měsíci, měřeno pomocí dotazníku HAD (skóre 0 až 21)
Časové okno: 12 měsíců
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12 měsíců
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Weight reduction of at least 5% between 0 and 6 months.
Časové okno: 6 months
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Weight, in Kg, measured in the same conditon at baseline and 6 months. |
6 months
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Weight change between 0 and 6 months
Časové okno: 6 months
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Weight, in Kg, measured in the same conditon at baseline and 6 months. |
6 months
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Weight change between 0 and 12 months
Časové okno: 12 months
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Weight, in Kg, measured in the same conditon at baseline and 12 months. |
12 months
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Waist change between 0 and 6 months
Časové okno: 6 months
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Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest |
6 months
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Waist change between 0 and 12 months
Časové okno: 12 months
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Waist, in cm, measured midway between the last ribs and the anterior superior iliac crest |
12 months
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Triglycerids change between 0 and 12 months
Časové okno: 12 months
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Plasma fasting levels of triglycerides in g/L |
12 months
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HDL cholesterol change between 0 and 12 months
Časové okno: 12 months
|
Plasma fasting levels of HDL cholesterol in g/L |
12 months
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LDL cholesterol change between 0 and 12 months
Časové okno: 12 months
|
Plasma fasting levels of LDL cholesterol in g/L |
12 months
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non-HDL cholesterol change between 0 and 12 months
Časové okno: 12 months
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Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C) |
12 months
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Blood glucose change between 0 and 12 months
Časové okno: 12 months
|
Plasma fasting levels of glucose in g/L |
12 months
|
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HbA1c change between 0 and 12 months
Časové okno: 12 months
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Plasma fasting levels of HbA1c in percentage |
12 months
|
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Systolic blood pressure change between 0 and 12 months
Časové okno: 12 months
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Systolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
12 months
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Diastolic blood pressure change between 0 and 12 months
Časové okno: 12 months
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Diastolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
12 months
|
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Triglycerids change between 0 and 6 months
Časové okno: 6 months
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Plasma fasting levels of triglycerides in g/L |
6 months
|
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HDL cholesterol change between 0 and 6 months
Časové okno: 6 months
|
Plasma fasting levels of HDL cholesterol in g/L |
6 months
|
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LDL cholesterol change between 0 and 6 months
Časové okno: 6 months
|
Plasma fasting levels of LDL cholesterol in g/L |
6 months
|
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non-HDL cholesterol change between 0 and 6 months
Časové okno: 6 months
|
Plasma fasting levels of non-HDL cholesterol in g/L (total cholesterol less HDL-C) |
6 months
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Blood glucose change between 0 and 6 months
Časové okno: 6 months
|
Plasma fasting levels of glucose in g/L |
6 months
|
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HbA1c change between 0 and 6 months
Časové okno: 6 months
|
Plasma fasting levels of HbA1c in percentage |
6 months
|
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Systolic blood pressure change between 0 and 6 months
Časové okno: 6 months
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Systolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
6 months
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Diastolic blood pressure change between 0 and 6 months
Časové okno: 6 months
|
Diastolic blood pressure in mmHg as the average of the last 2 automatic measurements out of 3 taken at the level of one arm and spaced about 2 min in the cabinet or by the patient with the auto-tensiometer |
6 months
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Change in adherence to the Mediterranean diet : Score PREDIMED
Časové okno: 12 months
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Change between 0 and 12 months of adherence to mediterranean diet,evaluated by the dietetic score PREDIMED (validated checklist of 14 items). Higher scores indicate greater adherence to the diet assigned |
12 months
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Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Časové okno: 12 months
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Change between 0 and 12 months in terms of perrcentage of consumption of fruits and vegetables on the recommended 400 g/day |
12 months
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Change in adherence to the Mediterranean diet : Score PREDIMED
Časové okno: 6 months
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Change between 0 and 6 months of adherence to mediterranean diet,evaluated by the dietetic score PREDIMED (validated checklist of 14 items). Higher scores indicate greater adherence to the diet assigned |
6 months
|
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Change in adherence to the Mediterranean diet : fruits and vegetables consumption
Časové okno: 6 months
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Change between 0 and 6 months in terms of percentage of consumption of fruits and vegetables on the recommended 400 g/day |
6 months
|
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Change between 0 and 12 months of Energy intake
Časové okno: 12 months
|
Energy intake, in Kcal/day, evaluated with the validated NAQA questionnaire |
12 months
|
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Change between 0 and 12 months of cholesterol intake
Časové okno: 12 months
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Cholesterol intake, in mg/day, evaluated with the validated NAQA questionnaire |
12 months
|
Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Marylou Para, MD, PhD, Assistance Publique - Hôpitaux de Paris
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- K160908J
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
Data are available upon reasonable request. The procedures carried out with the French data privacy authority (CNIL, Commission nationale de l'informatique et des libertés) do not provide for the transmission of the database, nor do the information and consent documents signed by the patients.
Consultation by the editorial board or interested researchers of individual participant data that underlie the results reported in the article after deidentification may nevertheless be considered, subject to prior determination of the terms and conditions of such consultation and in respect for compliance with the applicable regulations.
Časový rámec sdílení IPD
Beginning 3 months and ending 3 years following article publication. Requests out of these time frame can also be submitted to the sponsor
Kritéria přístupu pro sdílení IPD
Researchers who provide a methodologically sound proposal
Typ podpůrných informací pro sdílení IPD
- PROTOKOL STUDY
- MÍZA
- ICF
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