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Assessing the Value of eHealth for Bariatric Surgery (BePATIENT)

Primary Purpose

Bariatric Surgery, Obesity, Telemedicine

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Access to online eLearning module
Access to measurement devices
Conventional group
Sponsored by
Catharina Ziekenhuis Eindhoven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bariatric Surgery focused on measuring eHealth, Bariatric surgery, Obesity, Telemedicine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Catharina HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Conventional group

Online group

Device group

Arm Description

Treatment includes: 10 individual and 3 group consultations at the outpatient department by several disciplines in the first postoperative year. Additional visits if necessary No further access to the BePATIENT website

Treatment includes: Added to conventional group: Continuation of access to the BePATIENT website with: eLearning programs Informative videos Patient network Video consulting

Added to Online group:Four wireless devices, which are Weight Scale Blood Pressure Oximeter Activity Tracker

Outcomes

Primary Outcome Measures

Body Mass Index (BMI)
The BMI in kg/m2 at 2 years postoperatively.

Secondary Outcome Measures

Quality of Life
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.
Evolution of obesity related comorbidities
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.
Program commitment
A 6-item questionnaire to assess program commitment (Neubert & Cady 2001).
Technical errors biometric devices
Number of technical issues reported by patients or health care professionals
Length of hospitalization
Length of stay in hospital (days)
Return to work (days)
Number of days patients start working again after operation
Patients' satisfaction
Satisfactory assessment patients (Numeric Rate Scale 0-10)
Health care suppliers' satisfaction
Satisfactory assessment health care professional (Numeric Rate Scale 0-10)

Full Information

First Posted
December 6, 2017
Last Updated
January 10, 2018
Sponsor
Catharina Ziekenhuis Eindhoven
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1. Study Identification

Unique Protocol Identification Number
NCT03394638
Brief Title
Assessing the Value of eHealth for Bariatric Surgery
Acronym
BePATIENT
Official Title
Assessing the Value of eHealth for Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Unknown status
Study Start Date
February 21, 2017 (Actual)
Primary Completion Date
December 15, 2019 (Anticipated)
Study Completion Date
December 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Catharina Ziekenhuis Eindhoven

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bariatric Surgery, Obesity, Telemedicine
Keywords
eHealth, Bariatric surgery, Obesity, Telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
Treatment includes: 10 individual and 3 group consultations at the outpatient department by several disciplines in the first postoperative year. Additional visits if necessary No further access to the BePATIENT website
Arm Title
Online group
Arm Type
Experimental
Arm Description
Treatment includes: Added to conventional group: Continuation of access to the BePATIENT website with: eLearning programs Informative videos Patient network Video consulting
Arm Title
Device group
Arm Type
Experimental
Arm Description
Added to Online group:Four wireless devices, which are Weight Scale Blood Pressure Oximeter Activity Tracker
Intervention Type
Other
Intervention Name(s)
Access to online eLearning module
Intervention Description
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
Intervention Name(s)
Access to measurement devices
Intervention Description
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
Procedure
Intervention Name(s)
Conventional group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
The BMI in kg/m2 at 2 years postoperatively.
Time Frame
2 years after the operation
Secondary Outcome Measure Information:
Title
Quality of Life
Description
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.
Time Frame
At 1 and 2 years after the operation
Title
Evolution of obesity related comorbidities
Description
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.
Time Frame
At 1 and 2 years after the operation
Title
Program commitment
Description
A 6-item questionnaire to assess program commitment (Neubert & Cady 2001).
Time Frame
At 1 and 2 years after the operation
Title
Technical errors biometric devices
Description
Number of technical issues reported by patients or health care professionals
Time Frame
At 2 years after the operation
Title
Length of hospitalization
Description
Length of stay in hospital (days)
Time Frame
At 2 years after the operation
Title
Return to work (days)
Description
Number of days patients start working again after operation
Time Frame
At 1 year after the operation.
Title
Patients' satisfaction
Description
Satisfactory assessment patients (Numeric Rate Scale 0-10)
Time Frame
At 1 and 2 years after the operation
Title
Health care suppliers' satisfaction
Description
Satisfactory assessment health care professional (Numeric Rate Scale 0-10)
Time Frame
At 1 and 2 years after the operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Completed the questionnaire online Having ongoing access to internet Ability to use a model of mobile device (smartphone or tablet) with any version of the Android or iOS platform 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) A primary gastric sleeve or bypass planned Age of 18 years or more Ability to read and write the Dutch language Signed informed consent Exclusion Criteria: 1. Patients not meeting the inclusion criteria
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dirk Versteegden, MD
Phone
003140 239 9850
Email
dirk.versteegden@catharinaziekenhuis.nl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Nienhuijs, MD, PhD
Organizational Affiliation
Department of Surgery, Catharina Hospital Eindhoven
Official's Role
Principal Investigator
Facility Information:
Facility Name
Catharina Hospital
City
Eindhoven
State/Province
Noord Brabant
ZIP/Postal Code
5623EJ
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dirk PA Versteegden, MD
Phone
040 239 9111
Email
dirk.versteegden@catharinaziekenhuis.nl

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Assessing the Value of eHealth for Bariatric Surgery

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