Assessing the Value of eHealth for Bariatric Surgery

NCT ID: NCT03394638

Last Updated: 2018-01-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-21
• Study Completion Date: 2019-12-15

Brief Summary

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.

Conditions

Bariatric Surgery; Obesity; Telemedicine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Conventional group

Treatment includes:

1. 10 individual and 3 group consultations at the outpatient department by several disciplines in the first postoperative year.

2. Additional visits if necessary

3. No further access to the BePATIENT website

Group Type: ACTIVE_COMPARATOR

Conventional group

Intervention Type: PROCEDURE

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.

Online group

Treatment includes:

Added to conventional group: Continuation of access to the BePATIENT website with:

1. eLearning programs

2. Informative videos

3. Patient network

4. Video consulting

Group Type: EXPERIMENTAL

Access to online eLearning module

Intervention Type: OTHER

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.

Conventional group

Intervention Type: PROCEDURE

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.

Device group

Added to Online group:Four wireless devices, which are

1. Weight Scale

2. Blood Pressure

3. Oximeter

4. Activity Tracker

Group Type: EXPERIMENTAL

Access to online eLearning module

Intervention Type: OTHER

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.

Access to measurement devices

Intervention Type: OTHER

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.

Conventional group

Intervention Type: PROCEDURE

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.

Interventions

Access to online eLearning module

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.

Intervention Type: OTHER

Access to measurement devices

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.

Intervention Type: OTHER

Conventional group

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Completed the questionnaire online

2. Having ongoing access to internet

3. Ability to use a model of mobile device (smartphone or tablet) with any version of the Android or iOS platform

4. 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)

5. A primary gastric sleeve or bypass planned

6. Age of 18 years or more

7. Ability to read and write the Dutch language

8. Signed informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Catharina Ziekenhuis Eindhoven

OTHER

Sponsor Role: lead

Responsible Party

Dirk Versteegden

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Nienhuijs, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Surgery, Catharina Hospital Eindhoven

Locations

Catharina Hospital

Eindhoven, North Brabant, Netherlands

Site Status: RECRUITING

Countries

Netherlands

Central Contacts

Dirk Versteegden, MD

Role: CONTACT

dirk.versteegden@catharinaziekenhuis.nl

003140 239 9850

Facility Contacts

Dirk PA Versteegden, MD

Role: primary

dirk.versteegden@catharinaziekenhuis.nl

040 239 9111

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Other Identifiers

NL56992.100.16

Identifier Type: -

Identifier Source: org_study_id