Assessing the Value of eHealth for Bariatric Surgery
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
Bariatric surgery is the only treatment with long standing effect of morbid obesity. The key elements to success are the patient-selection, an experienced bariatric team and a completed follow-up program. Follow-up programs can consist of, for example, providing social support in support groups, teaching psychological skills, such as coping with the body change or teaching self-regulation of body weight. Furthermore, follow-up is important for dietary and sports counselling. The experience of the team members and coaching skills are essential in indicating the suitable procedure if necessary and guide the patients through the process. Various studies showed a significant positive effect of a completed follow-up program after bariatric surgery on maintaining weight loss. There is a burden for this on site provided care as organizational and financial resources are not unlimited. Especially as the follow-up period is an obligatory 5 years or if possible life long. Even if this aftercare is provided, not all patients complete the complete program. Various reasons are possible for an increasing no-show-rate, the loss of enthusiasm for onsite visits could be one of them. Analogue to other chronic diseases, the addition of telehealth could be useful. Telehealth is the delivery of health-related services and information via telecommunications technologies. It encompasses preventative, promotive and curative aspects. Examples are exchanging health services or education via videoconference, transmission of medical data for disease management (remote monitoring) and advice on prevention of diseases and promotion of good health by patient monitoring and follow-up. The participation of eHealth has been investigated and considered useful in the treatment of obesity. In a systematic review self-measured blood pressure monitoring was associated with better control of hypertension at least in the first year. Its value in a bariatric tract has not been investigated. It can be hypothesized that self-control by eHealth could enhance clinical outcome as more weight loss and comorbidity reduction. Long-term realistic goals setting, consistent use of routines and self-monitoring has been proven effective for weight loss maintenance. Patients with higher self-control are more certain regarding their abilities, which cause higher commitment and adherence to the program. This eventually leads to more weight loss. For this purpose an online monitoring program was designed for our Obesity Centre (BePATIENT) to provide preoperative information as well as aids in the post-bariatric phase by self-control wireless devices for registration of biometric outcomes, teleconference opportunities and access to additional information. In a prospective trial the implementation in several degrees is evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Completed the questionnaire online
- •Having ongoing access to internet
- •Ability to use a model of mobile device (smartphone or tablet) with any version of the Android or iOS platform
- •A body mass index above 40 kg/m2 or above 35 kg/m2 with related comorbidity (hypertension, diabetes type 2, hyperlipidaemia, obstructive sleep apnea syndrome or joint arthritis of lower limbs)
- •A primary gastric sleeve or bypass planned
- •Age of 18 years or more
- •Ability to read and write the Dutch language
- •Signed informed consent
排除标准
- •Patients not meeting the inclusion criteria
研究组 & 干预措施
Conventional group
Treatment includes:
- 10 individual and 3 group consultations at the outpatient department by several disciplines in the first postoperative year.
- Additional visits if necessary
- No further access to the BePATIENT website
干预措施: Conventional group (Procedure)
Online group
Treatment includes:
Added to conventional group: Continuation of access to the BePATIENT website with:
- eLearning programs
- Informative videos
- Patient network
- Video consulting
干预措施: Access to online eLearning module (Other)
Online group
Treatment includes:
Added to conventional group: Continuation of access to the BePATIENT website with:
- eLearning programs
- Informative videos
- Patient network
- Video consulting
干预措施: Conventional group (Procedure)
Device group
Added to Online group:Four wireless devices, which are
- Weight Scale
- Blood Pressure
- Oximeter
- Activity Tracker
干预措施: Access to online eLearning module (Other)
Device group
Added to Online group:Four wireless devices, which are
- Weight Scale
- Blood Pressure
- Oximeter
- Activity Tracker
干预措施: Access to measurement devices (Other)
Device group
Added to Online group:Four wireless devices, which are
- Weight Scale
- Blood Pressure
- Oximeter
- Activity Tracker
干预措施: Conventional group (Procedure)
结局指标
主要结局
Body Mass Index (BMI)
时间窗: 2 years after the operation
The BMI in kg/m2 at 2 years postoperatively.
次要结局
- Technical errors biometric devices(At 2 years after the operation)
- Quality of Life(At 1 and 2 years after the operation)
- Evolution of obesity related comorbidities(At 1 and 2 years after the operation)
- Program commitment(At 1 and 2 years after the operation)
- Length of hospitalization(At 2 years after the operation)
- Return to work (days)(At 1 year after the operation.)
- Patients' satisfaction(At 1 and 2 years after the operation)
- Health care suppliers' satisfaction(At 1 and 2 years after the operation)
研究者
Dirk Versteegden
MD
Catharina Ziekenhuis Eindhoven
