Assessing the Value of eHealth for Bariatric Surgery (BePATIENT)

January 10, 2018 updated by: Dirk Versteegden, Catharina Ziekenhuis Eindhoven
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Procedure: 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.
Experimental: 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
Procedure: 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.
Other: 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.
Experimental: Device group

Added to Online group:Four wireless devices, which are

  1. Weight Scale
  2. Blood Pressure
  3. Oximeter
  4. Activity Tracker
Procedure: 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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI)
Time Frame: 2 years after the operation
The BMI in kg/m2 at 2 years postoperatively.
2 years after the operation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Quality of Life
Time Frame: At 1 and 2 years after the operation
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
Time Frame: At 1 and 2 years after the operation
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
Time Frame: At 1 and 2 years after the operation
A 6-item questionnaire to assess program commitment (Neubert & Cady 2001).
At 1 and 2 years after the operation
Technical errors biometric devices
Time Frame: At 2 years after the operation
Number of technical issues reported by patients or health care professionals
At 2 years after the operation
Length of hospitalization
Time Frame: At 2 years after the operation
Length of stay in hospital (days)
At 2 years after the operation
Return to work (days)
Time Frame: At 1 year after the operation.
Number of days patients start working again after operation
At 1 year after the operation.
Patients' satisfaction
Time Frame: At 1 and 2 years after the operation
Satisfactory assessment patients (Numeric Rate Scale 0-10)
At 1 and 2 years after the operation
Health care suppliers' satisfaction
Time Frame: At 1 and 2 years after the operation
Satisfactory assessment health care professional (Numeric Rate Scale 0-10)
At 1 and 2 years after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Catharina Ziekenhuis Eindhoven

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Simon Nienhuijs, MD, PhD, Department of Surgery, Catharina Hospital Eindhoven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 21, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 15, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 3, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 10, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL56992.100.16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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