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BePatient trial and eHealth

BePatient trial: the value of eHealth on bariatric surgery outcomes

Does an eHealth platform increase weight loss after bariatric surgery?
Does providing patients with electronical wireless monitoring devices lead to more weight loss?

Researchers from the Department of Surgery, Catharina Hospital, Eindhoven, the Netherlands, are carrying out the BePatient trial to determine whether patients benefit from different degrees of eHealth and self-monitoring. The researchers hypothesised that the more eHealth is provided, the higher post-operative weight loss will be, the less likely additional contacts/visits will be consumed, the higher the patients’ satisfaction will be, and the more benefits in co-morbidity will be found.

The addition of eHealth provides the patients more self-control, which could result in better commitment to the follow-up programme. The primary study hypothesis is that the benefit of adding eHealth to a bariatric care programme would lead to a larger reduction in BMI two years after the procedure compared to standard care.

Two main research questions are addressed:

  • Does an eHealth platform increase weight loss after bariatric surgery?
  • Does providing patients with electronical wireless monitoring devices lead to more weight loss?

The paper describing the trial protocol, ‘Assessing the value of eHealth for bariatric surgery (BePatient trial): study protocol for a randomized controlled trial’, was published in Trials, a Springer Nature journal. It is hoped this research will contribute to the still small body of evidence around the value of eHealth.

In total, 200 adult patients with a BMI≥40 or ≥35 with obesity-related co-morbidity, undergoing sleeve gastrectomy or gastric bypass will be enrolled in this randomised controlled trial. Patients will be randomly assigned to one of the groups: receiving standard care (control group, n=100); have access to an online eHealth platform in addition to the previous group (online group, n=50); or receive wireless monitoring devices in addition to previous groups (device group, n=50). The total follow-up period is two years post-operatively. Primary outcome is weight loss in terms of BMI. Secondary outcomes include: quality of life; return-to-work time; co-morbidity reduction; additional contacts; and ease of use of devices. Figure 1 shows a flowchart illustrating the recruitment and allocation process in this trial.

Figure 1: Flowchart illustrating the recruitment and allocation process in this trial

The inclusion criteria to participate in this study are:

  • Completed the mandatory questionnaire online;
  • Having ongoing access to the Internet;
  • Ability to use a model of mobile device (smartphone or tablet);
  • A BMI>40 or >35 with related co-morbidity (hypertension, diabetes type 2, hyperlipidaemia, obstructive sleep apnoea syndrome, or arthralgia of lower limbs;
  • A primary gastric sleeve or bypass planned;
  • Age ≥ 18 years;
  • Ability to read and write the Dutch language; and
  • Signed informed consent.

Those who did not met the abovementioned inclusion criteria were excluded.

All patients will receive standard care which consists of a five-year follow-up scheme after the bariatric procedure. The first year consists of around 10 individual and three group consultations. These follow-up visits are usually at around one, three, six, eight, nine, ten, 12, 16, 20, and 24 months post-operatively and include consultations with their surgeon, dieticians, physiotherapists, and obesity nurses. After the first year, visits become less frequent. If deemed necessary, additional contact can be made. During the total follow-up time, blood markers are frequently assessed.

BePatient website

In addition to the standard care, patients in the online and device groups will have continued access to the patient platform. The Catharina BePatient website is a bariatric online module developed by BePatient, personalized to the hospital’s standard. Since the start of 2015, all new patients receive registration details to create a personal account. After patients register, they are asked to sign the user agreement, which includes gathering of data and providing access to these data by the medical team. A variety of content can be found on the platform, including: dietary tips; how to use medication; frequently asked questions; obesity-related facts; instruction videos of several physical exercises; and more. Users can also make a list of their eating habits which they can bring to the next appointment. The information is revised by healthcare professionals of the Catharina Hospital to make sure information is up-to-date. Furthermore, new information and lectures are added frequently.

eHealth platform

In addition to standard care and access to the eHealth platform, patients in the device group also have access to four wireless telemonitoring devices: a weighing scale; a blood pressure meter; oxygen saturation meter; and an activity bracelet. All devices are connectable with most smartphones and tablets using Bluetooth. By doing this, they can view their measurements on dedicated mobile applications. This can be displayed as a list of measurements or in a graph. By doing this they can track their progress in, for instance, weight loss. Patients can also set goals to achieve, for instance, a total number of steps or distances walked. These measurements are also visible on their platform accounts once they synchronize the devices to their BePatient accounts. This gives the research team insight in the frequency of use of the devices.

“A dedicated eHealth platform can aid or support communication towards patients. However, the value of eHealth is not yet established. Reviews on the efficacy of eHealth interventions for weight loss and weight loss maintenance show promising effects,” the authors noted. “This trial is the first randomised research that evaluates the effects of different levels of eHealth compared to a control group after bariatric surgery.”

The recruitment of participants started in February 2017 and the trial is ongoing. Outcomes are planned to be published in a peer-reviewed journal upon completion.

To access this paper, please click here

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