Observational Study of Wearable Health Monitoring Device

NCT05368389 | Completed FDA Device

• 1 other identifier: 21-007489
• Study Type: observational
• Target: 33
• Locations: 1 country
• Sites: 1

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).

Conditions

Weight Loss

Outcome Measures

Primary Outcomes (1)

• Transmit number

  The number of times data is collected successfully from the Healthdot device.

  10 days

Secondary Outcomes (2)

• Patient Satisfaction Questionnaire

  Day 10

• Provider Satisfaction Questionnaire

  6 month

Study Arms (2)

Healthdot Patients

This group represents the patient who have undergone a bariatric procedure and had the Healthdot device attached and had data collected from the device for 10 days.

Device: Healthdot attachment

Healthdot providers

This group represents the providers or study/hospital staff who were involved in the attachment, recruitment, and enrollment of the Healthdot patients.

Interventions

Healthdot attachment DEVICE

The wearable health monitoring device "Healthdot 5" will be attached to the patient's skin at left lower rib and data like heart rate, respiratory rate, posture and activity will be collected for 10 days. A questionnaire will be sent to patients to fill out at the 10th day after the device attachment.

Healthdot Patients

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Philips Healthcare: collaborator

Study Sites (1)

Karl Akiki

Rochester, Minnesota, 55902, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Eric K Vargas Valls, MD, MS

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 6, 2022
• First Posted: May 10, 2022
• Study Start: November 3, 2022
• Primary Completion: June 21, 2023
• Study Completion: June 21, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

US (1)