Observational Study of Wearable Health Monitoring Device

Completed

• Conditions: Weight Loss
• Interventions: Device: Healthdot attachment

• Registration Number: NCT05368389
• Lead Sponsor: Mayo Clinic

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.

Study Timeline

• Study First Submitted: 2022-05-06
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-10
• Study Start: 2022-11-03
• Primary Completion: 2023-06-21
• Study Completion: 2023-06-21
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthdot Patients	Healthdot attachment	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.

Primary Outcome Measures

Name	Time	Method
Transmit number	10 days	The number of times data is collected successfully from the Healthdot device.

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Questionnaire	Day 10	The questionnaire will be sent to bariatric patients with questions regarding the usability and satisfaction wearing the healthdot device. The answer will be represented in multiple choices. The answers will be collected and the data will be analyzed.; Each question will be scored on a likert scale 0 being the lowest score and 5 the highest.
Provider Satisfaction Questionnaire	6 month	The questionnaire will be sent to providers and Study staff with questions regarding the usability and satisfaction of using and attaching the Healthdot device in the hospital setting. The answer will be represented in multiple choices and open answers. The answers will be collected and the data will be analyzed.

Trial Locations

Locations (1)

Karl Akiki; 🇺🇸 Rochester, Minnesota, United States