Clinical trial NCT05368389: Observational Study of Wearable Health Monitoring Device
Official title: Observational Feasibility Study of the Healthdot Wearable Monitoring Device in Bariatric Patients at Mayo Clinic
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Weight Loss
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Philips Healthcare
First posted: 2022-05-10
Enrollment: 33
Sex: ALL
Minimum age (years): 22
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In this clinical study, 30 patients undergoing a bariatric procedure (ESG, Balloon, Bariatric Surgery, Revision after Bariatric Surgery) will be enrolled.

An estimate of 10 providers/Hospital Staff will be accrued for the study to fill out a provider satisfaction questionnaire regarding the Healthdot device.

Brief summary: The purpose of this study is to better understand the use of Healthdot devices on bariatric patients in the USA. Healthdot is a wearable monitoring device that can collect data on heart rate, respiration rate, posture, and activity. This device can be worn at the hospital and at home. The Healthdot will be able to send data and have good connectivity in a place where there is network coverage(4G/5G).

Detailed description: This clinical study is a single-center observational feasibility study of the Healthdot device, a wearable health monitoring device applied to bariatric surgery/endoscopy patients for in-hospital and at-home data collection of heart rate, respiration rate, posture, and activity. After surgery, 30 bariatric patients will be applied with the Healthdot device. Patient data will be collected for a total of 10 days to evaluate the feasibility of the use of the Healthdot device at Mayo Clinic and at home. Patient data will only be observed retrospectively, so after the data collection period of 10 days has been concluded, the clinical care will not be affected by this. Feasibility includes the connectivity performance, the usability from a hospital staff perspective with a focus on staff satisfaction and potential interference with hospital workflow, and the usability from a patient perspective with a focus on patient satisfaction and potential interference with normal daily activities. The collected information will be processed to establish the feasibility of a larger interventional clinical trial using Healthdot in bariatric patients.

Eligibility criteria: Inclusion Criteria:

* Patients being seen for upcoming planned weight-loss procedure (ESG, Balloon, Bariatric Surgery, Revision after Bariatric Surgery).
* Commitment to wear device without removing for entire study period.
* Located within a driving distance from Mayo Clinic in Rochester, Minnesota during study duration.
* Reside in an area with 4G or 5G connectivity based on cellphone provider maps for T-Mobile or AT\&T.
* Subject clear of any dermatologic health diagnosis that may impede the ability of the device to adhere properly.

Exclusion Criteria:

* Unable to give consent.
* Unwillingness to utilize email address for device instructions, surveys, and reminders.
* Lifestyle that would have the device exposed to excessive elements for a prolonged period of time outside the parameters of normal operation of the device.
* Patient is expected/anticipated to fly (use an airplane) before study completion (before Day 10).
* Subjects with a pacemaker or an implanted electronic device.
* Subjects scheduled or likely to conduct MRI within the study period.
* Left lower rib (place where Healthdot will be applied) is involved in the area of surgery, area of disinfection or area where bandages are needed.
* Patients with severe systemic diseases.

Primary outcomes:
measure: Transmit number
timeFrame: 10 days
Secondary outcomes:
measure: Patient Satisfaction Questionnaire
timeFrame: Day 10
measure: Provider Satisfaction Questionnaire
timeFrame: 6 month
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Karl Akiki
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Eric K Vargas Valls, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: