NCT05368389

Observational Study of Wearable Health Monitoring Device

Observational Feasibility Study of the Healthdot Wearable Monitoring Device in Bariatric Patients at Mayo Clinic

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 33 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 22 Years – 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• Weight Loss

Interventions

Type	Name	Description
DEVICE	Healthdot attachment	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.

Timeline

• Start date: 2022-11-03
• Primary completion: 2023-06-21
• Completion: 2023-06-21
• First posted: 2022-05-10
• Last updated: 2024-03-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study