NCT03394638: BePATIENT

Assessing the Value of eHealth for Bariatric Surgery

Status unknown NA Last updated 11 January 2018

What this trial tests

NA trial testing Access to online eLearning module in Bariatric Surgery in 200 participants. Status unknown.

Timeline

21 February 2017

Primary endpoint
15 December 2019

15 December 2019

Quick facts

Lead sponsor	Catharina Ziekenhuis Eindhoven
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	200
Start date	21 February 2017
Primary completion	15 December 2019
Estimated completion	15 December 2019
Sites	1 location across Netherlands

Drugs / interventions tested

• Access to online eLearning module
• Access to measurement devices
• Conventional group — full drug profile →

Conditions studied

• Bariatric Surgery — all drugs for Bariatric Surgery →
• Obesity — all drugs for Obesity →
• Telemedicine — all drugs for Telemedicine →

Sponsor

Catharina Ziekenhuis Eindhoven — full company profile →

Who can join

18 and older, any sex, with Bariatric Surgery or Obesity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Assessing the value of eHealth for bariatric surgery (BePatient trial): study protocol for a randomized controlled trial.
   Versteegden DPA, Van Himbeeck MJJ, Nienhuijs SW. · · 2018 · cited 4× · PMID 30428902 · DOI 10.1186/s13063-018-3020-x
2. A randomized clinical trial evaluating eHealth in bariatric surgery.
   Versteegden DPA, Van Himbeeck MJJ, Luyer MD, van Montfort G, et al · · 2023 · cited 1× · PMID 37474829 · DOI 10.1007/s00464-023-10211-w