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)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Rates of patients lost to follow up
研究概览
简要总结
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
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- 未提供
研究组 & 干预措施
Standard multidisciplinary follow-up reinforced with telemedicine
Standard annual multidisciplinary follow-up, reinforced with telemedicine (remote quarterly motivational interviews)
干预措施: Quarterly remote motivational interviews (Other)
Standard multidisciplinary follow up
Standard annual multidisciplinary follow-up without telemedicine follow up
结局指标
主要结局
Rates of patients lost to follow up
时间窗: 4 years
Rates of patients lost to follow up measured in both arms and compared 4 years after randomization
次要结局
- The evolution of quality of life, self-esteem and perceived health compared to baseline(1,2,3 and 4 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.(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(1,2 and 3 years)