Weight LossNCT05368389
Observational Study of Wearable Health Monitoring Device
An observational study of Weight Loss, run by Mayo Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss
- What is being tested?
- Healthdot attachment
- Type of treatment
- Medical device
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Nov 2022to 21 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Observational Feasibility Study of the Healthdot Wearable Monitoring Device in Bariatric Patients at Mayo Clinic
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).
Read the 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
- Being tested
- Healthdot attachment
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthdot attachmentDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transmit number
The number of times data is collected successfully from the Healthdot device.
Measured: 10 days
Secondary outcomes (2)
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.
Measured: Day 10
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.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start3 Nov 2022
- Primary completion21 Jun 2023
- Study completion21 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Principal investigator, Eric J. Vargas Valls, Mayo Clinic
- Investigators
- Eric K Vargas Valls, MD, MS, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368389
- Sponsor's protocol ID
- 21-007489
- Status last verified
- Mar 2024
- First submitted
- 6 May 2022
- Last updated
- 28 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Feasibility Study of the Healthdot Wearable Monitoring Device in Bariatric Patients at Mayo Clinic
- ClinicalTrials.gov ID
- NCT05368389
- Acronym / sponsor ID
- 21-007489
- Conditions
- Weight Loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 3 Nov 2022 (actual)
- Primary completion
- 21 Jun 2023 (actual)
- Study completion
- 21 Jun 2023 (actual)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthdot Patients | – | Device: Healthdot attachmentThis 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. |
| Healthdot providers | – | –This group represents the providers or study/hospital staff who were involved in the attachment, recruitment, and enrollment of the Healthdot patients. |
Who may qualify
- Ages
- 22 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthdot attachmentThe 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. | Device | Healthdot Patients |
Primary outcome
Transmit number
Time frame: 10 days
The number of times data is collected successfully from the Healthdot device.
2 secondary outcomes
Patient Satisfaction Questionnaire
Time frame: Day 10
Provider Satisfaction Questionnaire
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2024.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric K Vargas Valls, MD, MS principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Weight Loss, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transmit number (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2024.