Fitness TrackersMONITORNCT05418881
Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients (MONITOR)
A study testing Mobile Tracking Device (one spot) and Mobile Tracking Device + Activity Sensor (longitudinal) in people with Fitness Trackers and Hemodynamic Monitoring, run by Wuerzburg University Hospital at 1 site in Germany.
Trial summary
The study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. Therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Fitness Trackers, Hemodynamic Monitoring, Internet of Things
- What is being tested?
- Mobile Tracking Device (one spot) and Mobile Tracking Device + Activity Sensor (longitudinal)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteGermany
- Study dates
- 1 Nov 2021to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with elective surgery (≥ 18 years).
- Written informed consent to participate in the study
- Planned invasive arterial blood pressure measurement
Who cannot join
- Postoperative invasive ventilation
- American Society of Anaesthesiologists (ASA) Class V
- Outpatient surgical procedure
- Previous participation in this study
- Patients unable to give consent or patients who do not have adequate German language skills
- Suspected lack of compliance
- Skin lesions of the forearms or inability to wear a tracking device
- Known allergy to latex/silicone/nickel
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Wuerzburg University Hospital
Würzburg, Bavaria, 97080
Philipp Helmer, Dr., +4993120130574, helmer_p@ukw.de
Sebastian Hottenrott, +4993120130563, hottenrott_s@ukw.de
About this study
Official title: Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients - MONITOR 2022
The study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. Therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. Factors that could have an influence on the measurement accuracy of the mobile sensors will be investigated.Furthermore patient compliance in continous use of mobile health trackers and technical feasibility of needed data flow will be analyzed. In addition, patients' activity levels are recorded and correlated with various clinical parameters.
- Conditions
- Fitness Trackers, Hemodynamic Monitoring, Internet of Things, Postoperative Complications, Wearable Electronic Devices, Anesthesia
- Being tested
- Mobile Tracking Device (one spot), Mobile Tracking Device + Activity Sensor (longitudinal)
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Tracking Device (one spot)Device
Patients will be fitted with 4 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, FitBit Sense®, Withings ScanWatch®).
Mobile Tracking Device + Activity Sensor (longitudinal)Device
Patients will be fitted with 1 of 3 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, Withings ScanWatch®). The type of tracking device will be randomized. Additionally an Activity Tracker and one-channel ECG (Movesense®) will be worn by the patients.
| Study group | Role | What they receive |
|---|---|---|
| postoperative Spot Measurements | Other | Measurement of vital signs via 4 different tracking devices in the setting of post-anaesthesia care unit. Simultaneous collection of vital signs measured by the gold standard of clinical monitoring (ecg, blood-gas-analysis, invasive blood pressure, transmissive photoplethysmography). Receives: Device: Mobile Tracking Device (one spot) |
| Longitudinal postoperative Measurements | Other | Continuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative. Receives: Device: Mobile Tracking Device (one spot); Device: Mobile Tracking Device + Activity Sensor (longitudinal) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement accuracy
Heart rate as compared to ECG
Measured: postoperative until hospital discharge up to 21 days
Measurement accuracy
Oxygen saturation as compared to arterial blood gas analysis
Measured: postoperative until hospital discharge up to 21 days
Secondary outcomes (3)
Patient compliance with mobile tracking devices
As measured by a survey
Measured: postoperative until hospital discharge up to 21 days
Postoperative inertial movement
As measured by an inertial activity sensor (MoveSense®) in "inertial measurement units" (IMU)
Measured: postoperative until hospital discharge up to 21 days
Postoperative step count
As measured by tracking devices in steps per day
Measured: postoperative until hospital discharge up to 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start1 Nov 2021
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Nov 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Fitness TrackersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuerzburg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wuerzburg
- Responsible party
- Sponsor
- Investigators
- Patrick Meybohm, Prof. Dr., Study director, Wuerzburg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05418881
- Sponsor's protocol ID
- MONITOR 2022
- Acronym
- MONITOR
- Status last verified
- Jun 2022
- First submitted
- 18 May 2022
- Last updated
- 14 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Helmer P, Hottenrott S, Wienboker K, Brugger J, Stoppe C, Schmid B, Kranke P, Meybohm P, Sammeth M. Postoperative use of fitness trackers for continuous monitoring of vital signs: a survey of hospitalized patients. J Clin Monit Comput. 2025 Oct;39(5):1077-1086. doi: 10.1007/s10877-025-01273-3. Epub 2025 Mar 6.
PubMed 40050564Helmer P, Hottenrott S, Rodemers P, Leppich R, Helwich M, Pryss R, Kranke P, Meybohm P, Winkler BE, Sammeth M. Accuracy and Systematic Biases of Heart Rate Measurements by Consumer-Grade Fitness Trackers in Postoperative Patients: Prospective Clinical Trial. J Med Internet Res. 2022 Dec 30;24(12):e42359. doi: 10.2196/42359.
PubMed 36583938
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Implementation of Mobile Tracking Devices to Increase Safety in Hospitalized Patients - MONITOR 2022
- ClinicalTrials.gov ID
- NCT05418881
- Acronym / sponsor ID
- MONITOR / MONITOR 2022
- Conditions
- Fitness Trackers, Hemodynamic Monitoring, Internet of Things, Postoperative Complications, Wearable Electronic Devices, Anesthesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Wuerzburg University HospitalUniversity, hospital or other
- Collaborators
- University of Wuerzburg
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Nov 2023 (estimated)
- First posted
- 14 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the technical feasibility of using mobile health trackers for monitoring of hospitalized patients. Therefore the measurement accuracy of several vital parameters in postoperative hospitalized patients will be compared to clinical gold standard. Factors that could have an influence on the measurement accuracy of the mobile sensors will be investigated.Furthermore patient compliance in continous use of mobile health trackers and technical feasibility of needed data flow will be analyzed. In addition, patients' activity levels are recorded and correlated with various clinical parameters.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| postoperative Spot Measurements | Other | Device: Mobile Tracking Device (one spot)Measurement of vital signs via 4 different tracking devices in the setting of post-anaesthesia care unit. Simultaneous collection of vital signs measured by the gold standard of clinical monitoring (ecg, blood-gas-analysis, invasive blood pressure, transmissive photoplethysmography). |
| Longitudinal postoperative Measurements | Other | Device: Mobile Tracking Device (one spot), Device: Mobile Tracking Device + Activity Sensor (longitudinal)Continuous measurement of vital signs and activity level with tracking devices for the postoperative period in the patient ward up until 21 days postoperative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with elective surgery (≥ 18 years).
- Written informed consent to participate in the study
- Planned invasive arterial blood pressure measurement
Key exclusion criteria (8 listed)
- Postoperative invasive ventilation
- American Society of Anaesthesiologists (ASA) Class V
- Outpatient surgical procedure
- Previous participation in this study
- Patients unable to give consent or patients who do not have adequate German language skills
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Tracking Device (one spot)Patients will be fitted with 4 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, FitBit Sense®, Withings ScanWatch®). | Device | Longitudinal postoperative Measurements, postoperative Spot Measurements |
| Mobile Tracking Device + Activity Sensor (longitudinal)Patients will be fitted with 1 of 3 different tracking devices (Garmin Fenix 6 Pro®, Apple Watch 7®, Withings ScanWatch®). The type of tracking device will be randomized. Additionally an Activity Tracker and one-channel ECG (Movesense®) will be worn by the patients. | Device | Longitudinal postoperative Measurements |
Primary outcome
Measurement accuracy
Time frame: postoperative until hospital discharge up to 21 days
Heart rate as compared to ECG
Measurement accuracy
Time frame: postoperative until hospital discharge up to 21 days
Oxygen saturation as compared to arterial blood gas analysis
3 secondary outcomes
Patient compliance with mobile tracking devices
Time frame: postoperative until hospital discharge up to 21 days
Postoperative inertial movement
Time frame: postoperative until hospital discharge up to 21 days
Postoperative step count
Time frame: postoperative until hospital discharge up to 21 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2022.
- Derived from this study: PubMed 40050564Helmer P, Hottenrott S, Wienboker K, Brugger J, Stoppe C, Schmid B, Kranke P, Meybohm P, Sammeth M. Postoperative use of fitness trackers for continuous monitoring of vital signs: a survey of hospitalized patients. J Clin Monit Comput. 2025 Oct;39(5):1077-1086. doi: 10.1007/s10877-025-01273-3. Epub 2025 Mar 6.
- Derived from this study: PubMed 36583938Helmer P, Hottenrott S, Rodemers P, Leppich R, Helwich M, Pryss R, Kranke P, Meybohm P, Winkler BE, Sammeth M. Accuracy and Systematic Biases of Heart Rate Measurements by Consumer-Grade Fitness Trackers in Postoperative Patients: Prospective Clinical Trial. J Med Internet Res. 2022 Dec 30;24(12):e42359. doi: 10.2196/42359.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Meybohm, Prof. Dr. study director
Wuerzburg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Tracking Device (one spot) and Mobile Tracking Device + Activity Sensor (longitudinal) in people with Fitness Trackers and Hemodynamic Monitoring, run by Wuerzburg University Hospital at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philipp Helmer, Dr. (+49 (931) 201 30574, helmer_p@ukw.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement accuracy (time frame: postoperative until hospital discharge up to 21 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05418881, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2022.