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BePATIENT-trial


- candidate number28232
- NTR NumberNTR6827
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-nov-2017
- Secondary IDsNL56992.100.16 
- Public TitleBePATIENT-trial
- Scientific TitleBePATIENT-trial
Assessing the value of eHealth for bariatric surgery
- ACRONYMn/a
- hypothesisAssessing the value of online education with and without remote monitoring added to standard perioperative bariatric care
- Healt Condition(s) or Problem(s) studiedBariatric surgery, Morbid obesity
- Inclusion criteria1. Completed the bariatric screening 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 apnoea syndrome, gastroesophageal reflux disease or joint arthritis of lower limbs)
5. A primary bariatric procedure planned (Gastric sleeve / Gastric bypass)
6. Age of 18 years or more
7. Ability to read and write the Dutch language
8. Signed informed consent
- Exclusion criteriaNot fulfilling the selection criteria
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2017
- planned closingdate31-dec-2020
- Target number of participants200
- InterventionseHealth program by BePATIENT containing

1. Online education module
- eLearning programs
- Videos
- Patient network
- Video consulting

2. Remote monitoring
- Weighing scale
- Blood pressure
- Activity tracker
- Oximeter


200 subjects will be allocated to receive in a 2:1:1 distribution into
1. standard perioperative bariatric care versus
2. added online education versus
3. added online education and remote monitoring
- Primary outcomeThe Body Mass Index at 2 years postoperatively
- Secondary outcome1. Quality of Life (RAND36)
2. Evolution related comorbidities (treatment severity)
3. Program commitment (Neubert & Cady 2001)
4. Additional contacts/visits (n)
5. Technical errors biometric devices (n)
6. Length of stay in hospital (days)
7. Return to work (days)
8. Patients’ satisfaction (Numeric Rate Scale)
9. Health care suppliers’ satisfaction (Numeric Rate Scale)
- Timepoints1, 3, 6, 9, 12, 18 and 24 months after bariatric procedure
- Trial web siten/a
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES S.W. Nienhuijs
- CONTACT for SCIENTIFIC QUERIES S.W. Nienhuijs
- Sponsor/Initiator Dr. S.W. Nienhuijs
- Funding
(Source(s) of Monetary or Material Support)
Dr. S.W. Nienhuijs
- Publicationsn/a
- Brief summaryLong-term effect of bariatric surgery is influenced by the compliance with a follow-up program. This committment could be improved by eHealth. However, to which extent this benefit is or whether it should be an interactive website or include remote monitoring as well remains unclear. This study compares a conventional follow-up program to programs including an educational portal and remote monitoring to assess the value of eHealth for bariatric surgery.
- Main changes (audit trail)
- RECORD19-nov-2017 - 2-dec-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl