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| Name | Class |
|---|---|
| Philips Healthcare | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Healthdot providers | This group represents the providers or study/hospital staff who were involved in the attachment, recruitment, and enrollment of the Healthdot patients. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Transmit number | The number of times data is collected successfully from the Healthdot device. | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Satisfaction Questionnaire | 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. | Day 10 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Eric K Vargas Valls, MD, MS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karl Akiki | Rochester | Minnesota | 55902 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Provider Satisfaction Questionnaire | 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. | 6 month |