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Assessing the Value of eHealth for Bariatric Surgery (BePATIENT)

Catharina Hospital logo

Catharina Hospital

Status

Unknown

Conditions

Bariatric Surgery
Obesity
Telemedicine

Treatments

Other: Access to online eLearning module
Procedure: Conventional group
Other: Access to measurement devices

Study type

Interventional

Funder types

Other

Identifiers

NCT03394638
NL56992.100.16

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Exclusion criteria

  1. Patients not meeting the inclusion criteria

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 3 patient groups

Conventional group
Active Comparator group
Description:
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
Treatment:
Procedure: Conventional group
Online group
Experimental group
Description:
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
Treatment:
Procedure: Conventional group
Other: Access to online eLearning module
Device group
Experimental group
Description:
Added to Online group:Four wireless devices, which are 1. Weight Scale 2. Blood Pressure 3. Oximeter 4. Activity Tracker
Treatment:
Other: Access to measurement devices
Procedure: Conventional group
Other: Access to online eLearning module

Trial contacts and locations

1

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Central trial contact

Dirk Versteegden, MD

Data sourced from clinicaltrials.gov

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