WellnessNCT05387590
Health Care Provider Preventiomter Study
A study testing Preventiometer device with wellness coaching in people with Wellness, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to evaluate health care providers' perceptions, ratings and motivation to adopt a novel and state of the art physical wellness assessment device, the Preventiometer. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Wellness
- What is being tested?
- Preventiometer device with wellness coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2024to Jan 2025
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Health care providers practicing at Mayo Clinic.
- Able to speak English and complete surveys.
- Able to read, understand and sign inform consent.
Who cannot join
- Unable to sign inform consent.
- Pregnant women. (As verbalized by participant).
- Unable to ambulate without assistance.
- Not currently involved in another formal program or research study involving wellness coaching.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Health Care Providers Perceptions, Ratings and Motivation to Adopt/Utilize a Novel and State of the Art Physical Wellness Assessment Device (Preventiometer)
The purpose of this study is to evaluate health care providers' perceptions, ratings and motivation to adopt a novel and state of the art physical wellness assessment device, the Preventiometer.
Read the detailed description
The Preventiometer is a physical wellness tool that assesses multiple physical wellness measurements in a 60 +/- 15 minute period of time.
- Conditions
- Wellness
- Being tested
- Preventiometer device with wellness coaching
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventiometer device with wellness coachingBehavioural
Four wellness coaching sessions with a certified wellness coach to develop and implement your own personalized wellness plan will be included in this study.
| Study group | Role | What they receive |
|---|---|---|
| Preventiometer Device | Other | The Preventiometer is a physical wellness tool that assesses multiple physical wellness measures in a 60 ± 15 minutes period of time. It is intended to promote population wellness by empowering individuals to act upon the information they receive about their overall health. Receives: Behavioral: Preventiometer device with wellness coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Likert scale questionnaire on Preventiometer Wellness Assessment
Health care providers perception of the Preventiometer Wellness Device.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study startMay 2024 (estimated)
- Primary completionDec 2024 (estimated)
- Study completionJan 2025 (estimated)
Why it stopped: Unable to conduct study due to equipment not operational from study Sponsor team in Germany
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WellnessStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brent A. Bauer, Mayo Clinic
- Investigators
- Brent Bauer, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387590
- Sponsor's protocol ID
- 21-011313
- Status last verified
- Jun 2024
- First submitted
- 12 May 2022
- Last updated
- 27 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Care Providers Perceptions, Ratings and Motivation to Adopt/Utilize a Novel and State of the Art Physical Wellness Assessment Device (Preventiometer)
- ClinicalTrials.gov ID
- NCT05387590
- Acronym / sponsor ID
- 21-011313
- Conditions
- Wellness
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to conduct study due to equipment not operational from study Sponsor team in Germany
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 24 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 evaluate health care providers' perceptions, ratings and motivation to adopt a novel and state of the art physical wellness assessment device, the Preventiometer.
Detailed description
The Preventiometer is a physical wellness tool that assesses multiple physical wellness measurements in a 60 +/- 15 minute period of time.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Preventiometer Device | Other | Behavioral: Preventiometer device with wellness coachingThe Preventiometer is a physical wellness tool that assesses multiple physical wellness measures in a 60 ± 15 minutes period of time. It is intended to promote population wellness by empowering individuals to act upon the information they receive about their overall health. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Health care providers practicing at Mayo Clinic.
- Able to speak English and complete surveys.
- Able to read, understand and sign inform consent.
Key exclusion criteria (4 listed)
- Unable to sign inform consent.
- Pregnant women. (As verbalized by participant).
- Unable to ambulate without assistance.
- Not currently involved in another formal program or research study involving wellness coaching.
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 |
|---|---|---|
| Preventiometer device with wellness coachingFour wellness coaching sessions with a certified wellness coach to develop and implement your own personalized wellness plan will be included in this study. | Behavioural | Preventiometer Device |
Primary outcome
Likert scale questionnaire on Preventiometer Wellness Assessment
Time frame: 1 day
Health care providers perception of the Preventiometer Wellness Device.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 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.
Brent Bauer, MD 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?
A study testing Preventiometer device with wellness coaching in people with Wellness, 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 3 inclusion and 4 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: withdrawn, as of the sponsor's last update on 27 Jun 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 was withdrawn before enrolling participants, so there are no results.
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?
Likert scale questionnaire on Preventiometer Wellness Assessment (time frame: 1 day). 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 27 Jun 2024.