Monitoring the Weight Evolution Using a Connected Scale
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: Control Group, Intervention Group.
- Кому может быть актуально
- Состояния в реестре: Bariatric Surgery, Long Term Follow-Up, Weight Regain. Базовые параметры: от 18 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
Evaluation of a Personalized Care Path After Bariatric Surgery Based on Monitoring the Weight Evolution Using a Connected Scale
Обзор
Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation. This study will assess a new care pathway in which the patients are follow-up according to the weight evolution measured by the patient using a connected scale.
Подробное описание
Bariatric surgery is developing rapidly. In France, the number of annual interventions increased threefold between 2001 and 2015, from 16,000 to 50,000 per year. This rapid development is explained by the well-demonstrated benefits of surgery: spectacular improvement in the quality of life, reduction in co-morbidities (diabetes, cardiovascular diseases, and steatohepatitis), and significant reduction in mortality linked to severe obesity. However, the benefits of surgery may decrease over time and may be associated with side effects.
Current guideline recommend yearly multidisciplinary postoperative follow-up after bariatric surgery. However, practices remain very heterogeneous, and only a fraction of patients are still follow-up beyond two years after the operation. The current recommendations therefore do not seem adapted to clinical reality. They do not prevent the regain of weight in many patients, which frequently leads to re-operations. Even more worrying is the possible occurrence of late complications, sometimes serious and life-threatening.
This study will assess a new care pathway in which the patients are follow-up according to weight evolution measured by the patient using a connected scale.
Вмешательства
- Другое Control Group
Clinical visits conducted by a multidisciplinary team every year - Другое Intervention Group
Clinical visits are triggered by weight evolution measured by connected balance
Первичные конечные точки
- Evaluate the efficacy of new care pathway [Срок оценки: 3 years]
Вторичные конечные точки (12)
- Cost-effectiveness of new care pathway [Срок оценки: 3 years]
- Number of visits made by the multidisciplinary team [Срок оценки: 3 years]
- Number of postoperative surgical and / or medical complications [Срок оценки: 3 years]
- Change of nutritional parameters in the blood of vitamines [Срок оценки: 3 years]
- Change of nutritional parameters in the blood of minerals [Срок оценки: 3 years]
- Change of nutritional parameters in the blood of protein [Срок оценки: 3 years]
- Dutch Eating Behavior Questionnaire (DEBQ) [Срок оценки: 3 years]
- Frequency of Food Consumption Questionnaire [Срок оценки: 3 years]
- Anxiety and depression by Hospital Anxiety and Depression Scale questionnaire (HAD) [Срок оценки: 3 years]
- Ricci-Gagnon score [Срок оценки: 3 years]
- Quality of life of SF36 [Срок оценки: 3 years]
- Quality of life of questionnaire EQ-5D-5L [Срок оценки: 3 years]
Критерии участия
Критерии включения
Patients aged> = at 18 years old Patients who have benefited from a Roux-en-Y Gastric By-Pass or Sleeve Gastrectomy bariatric surgery 2 years ago Preoperative Body Mass Index between 35 kg/m2 and 59 kg/m2 Access to the wired network at home. Social insured patient Patient who signed the informed consent
Критерии исключения
Lack of autonomy for the use of remote monitoring equipment or psychological or psychiatric disorders making it difficult to optimally use the remote monitoring equipment
Administrative reasons: inability to receive informed consent information, inability to participate in the entire study, lack of social security coverage, refusal to sign consent, patient under guardianship or justice system.
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
- Профилактика
Центры проведения
Франция · 2 центра
- Ch Boulogne-Sur-Mer - Boulogne Sur Mer — Boulogne-sur-Mer
- Hop Claude Huriez Chu Lille — Lille
Идентификаторы
NCT: NCT04639778 · 2017_78 · 2018-A01946-49