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Набор скоро начнётся NCT05954377

Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up of an Obesity Program

Без фазы С лечением Obesity

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Quarterly remote motivational interviews.
Кому может быть актуально
Состояния в реестре: Obesity. Базовые параметры: 18 лет — 60 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Prospective, Single-center, Randomized, Open Label Study Assessing the Contribution of Telemedicine Monitoring in Addition to Standard Follow-up, Strengthening an Obesity Program in Berry (FRANCE)

Обзор

STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of telemedicine, in addition to standard follow-up, strengthening an Obesity program in Berry (France). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program

Подробное описание

Obesity became a major public health issue in France. In 2019, obesity represented 5% of annual costs in health and was responsible of a 2.7% lost in France's Gross Domestic Product. In the scop of french health ministry's recommendations for obese patients'care and the territorial healthcare program; Saint-François' hospital set up 3 healthcare programs: "medical obesity"," interventional" and "post surgery". A very few number of studies aim to asse the efficacity of a long-term telemedicine follow-up after a bariatric medical care program. STROBERRY Study is a Prospective, monocentric, randomized, open-label study assessing the contribution of a long term, telemedical, personalized, educative quarterly, follow-up (4 years follow up), in addition to standard follow-up, strengthening an Obesity program in Berry (FRANCE). The principal objective is to study the effectiveness of a follow-up reinforced with telemedicine in addition to the standard multidisciplinary annual follow-up on the rate of patients lost to follow-up after initial or second line management in a multidisciplinary bariatric medical program

Вмешательства

  • Другое Quarterly remote motivational interviews
    Remote motivational interview will be in the form of quarterly telephone call (at 3, 6 and 9 months after the start of annual follow up; the patient is seen again at 12 months as part of the annual follow-up) and this for 4 years. It will be performed by medical staff trained in motivational interviewing and who have completed at least 40 hours training in therapeutic education

Первичные конечные точки

  • Rates of patients lost to follow up [Срок оценки: 4 years]
Вторичные конечные точки (3)
  • The evolution of quality of life, self-esteem and perceived health compared to baseline [Срок оценки: 1,2,3 and 4 years]
  • Rate of patients lost to follow-up will be assessed at standard annual visits at 1, 2 and 3 years after randomization [Срок оценки: 1,2 and 3 years]
  • Change in waist circumference (cm) compared with the baseline measurement will be assessed at standard annual visits at 1, 2, 3 and 4 years after randomization. [Срок оценки: 1,2,3 and 4 years]

Критерии участия

Критерии включения

  • Woman or Male aged from 18 to 60 years old included
  • Patient in obesity (BMI> or = 30)
  • Patient who has completed a multidisciplinary medical program for obesity management, as a first- or second-line intention (after initial obesity management) at the investigating center
  • Affiliation to a social security scheme
  • Patient informed of the study and who had signed the informed consent form

Non Inclusion Criteria:

  • Management of obesity within the framework of an exclusively interventional program, without redirection to a medical program
  • Managing obesity as part of a post-operative program
  • Pregnant or breastfeeding women
  • Patients deprived of liberty
  • Patients under legal protection

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Франция · 1 центр
  • Clinique Saint-François — Châteauroux

Идентификаторы

NCT: NCT05954377 · STROBERRY

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗