The Role of Home Telemonitoring in the Evaluation of Patients With Severe Obesity After a Period of Residential Metabolic Rehabilitation.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- + dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up.
研究概览
简要总结
The goal of this clinical trial is to compare, in a population of severely obese patients, two different kinds of follow-up after discharge from in-hospital rehabilitation programme.
The main questions addressed are:
- primary outcome: comparing the dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up.
- secondary outcome: comparing the amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.
Participants are given a set of instruments (scale, activity tracker, automatic blood pressure monitor, oxymeter, and glucometer) and asked to measure vital parameters following a predetermined schedule for one year. Subjects are asked to engage in regular physical activity and follow the nutritional guidelines received at the moment of discharge from hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 38-60 kg/m2,
- •age between 18 and 65 years,
- •patient residing in Piedmont, Lombardy
- •Recent admission to San Giuseppe Hospital in Piancavallo for a period of residential rehabilitation.
- •Patient with wi-fi and/or mobile data connection at home.
排除标准
- •illiteracy
- •inability to engage in physical activity
- •psychiatric illnesses capable of impairing the proper use of the devices provided by telemonitoring
- •cognitive impairment, mental retardation
- •predictability of long periods of stay abroad
- •anticipation or planning of pregnancy during the year following discharge
- •legal protection
结局指标
主要结局
+ dropout rate at month 11 of patients followed-up by a telemedicine methodology with that of a traditional outpatient visit follow-up.
时间窗: 12 months
Percentage of patients still in care at month 11 after discharge in each of the two subgroups.
次要结局
- amount of weight loss at month 11 in patients followed-up by telemedicine with that registered in patients followed-up by traditional outpatient visits.(12 months)