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SURPLUS-trial


- candidate number19472
- NTR NumberNTR4790
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR15-sep-2014
- Secondary IDsNL50324.060.14 
- Public TitleSURPLUS-trial
- Scientific TitleA randomized trial to assess the SURPLUS value of telehealth for the Catharina Obesity Centre
- ACRONYMSURPLUS
- hypothesisOnline coaching modules and wireless biometric measurements have surplus value in addition to standard coaching program after bariatric surgery
- Healt Condition(s) or Problem(s) studiedBariatric surgery
- Inclusion criteria- 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 or joint arthritis of lower limbs)
- A gastric sleeve / bypass / revision planned
- Completed the bariatric screening 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
- Age of 18 years or more
- Ability to read and write the Dutch language
- Signed informed consent
- Exclusion criteriaNot fulfilling the selectioncriteria
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-dec-2014
- planned closingdate1-mei-2016
- Target number of participants150
- Interventions150 selected patients postoperatively in the obesity center randomly divided into 3 groups; (1) standard counseling (2) standard counseling + online coaching modules (3) standard counseling + online coaching modules + wireless remote monitoring for the period of 12 months
- Primary outcomeNumeric Rating Scale for decision making after 12 months
- Secondary outcomeVerbal Descriptor Scale satisfactorily patients and caretakers Quality of life with RAND 36 questionnaire Reduction in weight and comorbidities Number of additional telephone contacts not leading to medical intervention Frequency technical failures of the wireless monitoring devices
- TimepointsBaseline, 3 and 12 months
- Trial web site
- statusstopped
- CONTACT FOR PUBLIC QUERIES S.W. Nienhuijs
- CONTACT for SCIENTIFIC QUERIES S.W. Nienhuijs
- Sponsor/Initiator Catharina Hospital Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Covidien Nederland
- Publications
- Brief summaryTelehealth has a great additinal value to standard care. The use in bariatric patients is described rarely, even though this group seems to be particularly suitable. These patients have to attend a postoperative follow-up program for 5 years, are often young adults and are internet minded nd could benefit from motivational coaching. Now, online coaching modules and remote monitoring devices are available. The real surplus value of these additions is still uncertain. In a randomised controlled the surplus value will be investigated.
- Main changes (audit trail)
- RECORD15-sep-2014 - 18-okt-2015


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