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Pilot study to test usability of wearable biosensor in elderly with non-specific complaints


- candidate number24678
- NTR NumberNTR6031
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-jul-2016
- Secondary IDsPhilips Research 
- Public TitlePilot study to test usability of wearable biosensor in elderly with non-specific complaints
- Scientific TitlePilot study to test usability of wearable biosensor in elderly with non-specific complaints -
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedOlder adults
- Inclusion criteriaGroup 1: Optimal triage in the pre-hospital setting
• Age ≥ 65 years;
• Patient at the GP’s office with non-specific complaint(s) only;
• Patient living in a home residence with/without home care or home residence;
• ISAR score ≥ 2;
• Informed consent.

Group 2: Follow-up of discharged patients from the internal medicine ward/ED.
• Age ≥ 65 years;
• Registered at the ED for Internal Medicine or patients will be discharged from the hospital;
• Patients do not present with specific complaints;
• Patients are ready for discharge home;
• Patients living at home (with/without home care) or home residence;
• ISAR ≥3;
• Informed consent.

Group 3: Control
• Age ≥ 65 years;
• Informed consent.
- Exclusion criteriaGroup 1: Optimal triage in the pre-hospital setting
• Patients with positive anamnesis and/or medical examination for specific complaints;
• Age < 65 year;
• Patients with life expectancy <3 months (terminally ill patients);
• ISAR score <2.
• Patients who have implanted defibrillators or pacemakers
• Damaged or very vulnerable skin around patch location
• Allergic to silicone or hydrocolloid adhesive materials

Group 2: Follow-up of discharged patients from the internal medicine ward/ED.
• Age < 65 years;
• Other specialties besides internal medicine;
• Patients with diagnosed dementia;
• Patients living in a nursing home;
• Patients with an active oncologic disease;
• Patients with a live expectancy of less than 3 months;
• ISAR <3 score.
• Patients who have implanted defibrillators or pacemakers
• Damaged or very vulnerable skin around patch location
• Allergic to silicone or hydrocolloid adhesive materials

Group 3: Control
• Age < 65 year;
• Co-morbidities
• Patients with life expectancy <3 months (terminally ill patients);
• Patients who have implanted defibrillators or pacemakers
• Damaged or very vulnerable skin around patch location
• Allergic to silicone or hydrocolloid adhesive materials
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeintervention
- planned startdate 1-sep-2016
- planned closingdate31-dec-2016
- Target number of participants30
- InterventionsThe participants will wear a wearable biosensor that will record the vital parameters continuously
- Primary outcomeTo assess the successful usage of the wearable biosensor with the smartphone app (i.e. patient feedback, caregiver feedback, raw device data, technical operational data),
- Secondary outcomeThe frailty index
- Timepoints30 days
- Trial web site
- status[default]
- CONTACT FOR PUBLIC QUERIES Celine Reverseau
- CONTACT for SCIENTIFIC QUERIES Celine Reverseau
- Sponsor/Initiator Philips Research Eindhoven
- Funding
(Source(s) of Monetary or Material Support)
Philips Research
- Publications
- Brief summaryThis study is designed to investigate the efficacy of wearable monitoring devices for elderly NSC-patients in 2 different use case scenarios. Use case 1 (patients in the pre-hospital setting), Use case 2 (patients discharged home from the ED or hospital). Each patient will wear a biosensor (on the chest) connected to an app (a smartphone is running the app) for a certain period of time as defined by the clinical investigation plan – the biosensor will measure vital signs and biometric signals. At the end of the study period, the patients will be asked some questions related to usability of the wearable biosensor with the smartphone app.
- Main changes (audit trail)
- RECORD21-jul-2016 - 16-okt-2016


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