Assessing the Value of eHealth for Bariatric Surgery

Study Overview
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Brief Summary
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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.

Official Title
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Assessing the Value of eHealth for Bariatric Surgery

Conditions
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Bariatric Surgery, Obesity, Telemedicine

Intervention / Treatment
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* Other: Access to online eLearning module
* Other: Access to measurement devices
* Procedure: Conventional group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 1. Patients not meeting the inclusion criteria

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Conventional group<br>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 | Procedure: Conventional group<br>* All patients undergo the standard of care which included: the bariatric procedure and several outpatient visits including consultation with their surgeon, obesity nurses, dieticians and (if indicated) psychologists.<br>|
| Experimental: Online group<br>Treatment includes: Added to conventional group: Continuation of access to the BePATIENT website with: eLearning programs Informative videos Patient network Video consulting | Other: Access to online eLearning module<br>* Patients enrolled in the Online group have access to an online platform called BePatient. Patients are given the ability to access the platform and do eLearnings; watch videos about the operation and recovery; do quizzes, see dietary advices; see news about obesity and our department; read patients' stories. They are also able to chat with other patients.<br>Procedure: Conventional group<br>* All patients undergo the standard of care which included: the bariatric procedure and several outpatient visits including consultation with their surgeon, obesity nurses, dieticians and (if indicated) psychologists.<br>|
| Experimental: Device group<br>Added to Online group:Four wireless devices, which are Weight Scale Blood Pressure Oximeter Activity Tracker | Other: Access to online eLearning module<br>* Patients enrolled in the Online group have access to an online platform called BePatient. Patients are given the ability to access the platform and do eLearnings; watch videos about the operation and recovery; do quizzes, see dietary advices; see news about obesity and our department; read patients' stories. They are also able to chat with other patients.<br>Other: Access to measurement devices<br>* Patients in the device group have, in addition to patients in the Online group, access to 4 measuring devices, including: weight scale, oximeter, activity bracelet and blood pressure device. Those devices are connectable to their mobile phones where patients can view their own progress.<br>Procedure: Conventional group<br>* All patients undergo the standard of care which included: the bariatric procedure and several outpatient visits including consultation with their surgeon, obesity nurses, dieticians and (if indicated) psychologists.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Mass Index (BMI) | The BMI in kg/m2 at 2 years postoperatively. | 2 years after the operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life | Quality of Life assessment using the RAND36-questionnaire. The RAND36 questionnaire consists of 36 questions about health related quality of life. The RAND36 scores are divided in 9 subscales: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, mental health and health change. Scores for each subscale are transformed to a linear 0 - 100 score. A higher score indicates a better quality of life in that domain. | At 1 and 2 years after the operation | 
| Evolution of obesity related comorbidities | Status of comorbidities are recorded at 1 and 2 years postoperatively and classified as either: cured (no medication and no complaints), improved (less medication needed and/or less complaints), unchanged (no alterations in medication use and no change in complaints), worsened (more medication needed and/or more complaints) or de novo (development of a comorbidity which was not present at inclusion). The reviewed comorbidities include: hypertension, diabetes mellitus, Arthralgia, obstructive sleep apnea syndrome, dyslipidemia and gastro-esophageal reflux disease. | At 1 and 2 years after the operation | 
| Program commitment | A 6-item questionnaire to assess program commitment (Neubert & Cady 2001). | At 1 and 2 years after the operation | 
| Technical errors biometric devices | Number of technical issues reported by patients or health care professionals | At 2 years after the operation | 
| Length of hospitalization | Length of stay in hospital (days) | At 2 years after the operation | 
| Return to work (days) | Number of days patients start working again after operation | At 1 year after the operation. | 
| Patients' satisfaction | Satisfactory assessment patients (Numeric Rate Scale 0-10) | At 1 and 2 years after the operation | 
| Health care suppliers' satisfaction | Satisfactory assessment health care professional (Numeric Rate Scale 0-10) | At 1 and 2 years after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eHealth, Bariatric surgery, Obesity, Telemedicine