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Personal Activity Intelligence (PAI) Pilot (PAI)

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ClinicalTrials.gov Identifier: NCT03740074
Recruitment Status : Recruiting
First Posted : November 14, 2018
Last Update Posted : November 14, 2018
Sponsor:
Information provided by (Responsible Party):
David Drozek, Ohio University

Brief Summary:
Pilot study to evaluate the use of the Personal Activity Intelligence (PAI) score in a clinical setting.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Diabetes Hypertension Dyslipidemias Cardiovascular Diseases Behavioral: PAI Not Applicable

Detailed Description:

This is a pilot project to evaluate the feasibility of a larger study to evaluate the effectiveness of Personal Activity Intelligence (PAI) score in patients with chronic disease, as an adjunct to lifestyle medical therapy.

The PAI score is a proprietary formula developed by PAI Health (PH) to aid physical fitness. A PAI score calculation uses biometrics obtained via a device that measures heart rate and steps. For this study, Mio Slice, a commercial wrist worn device will be utilized to obtain data which will be linked to a smart phone. Data from the smart phone app will be accessed by PAI Health. Feedback information will be given to the participants to encourage increased physical activity.

The short-term aim of this study is to evaluate the logistics of utilizing PAI in the patient setting.

The data obtained from this study will be utilized to devise a larger study to evaluate the utility of PAI in patients with chronic disease who are receiving lifestyle medical therapy.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Prospective pilot
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Personal Activity Intelligence (PAI) Score Pilot Study
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
Experimental: PAI
Participants will utilize a MIO Slice wearable device to generate a PAI score, which will be utilized to provide feedback and incentive for physical activity.
Behavioral: PAI

Consenting subjects will be given a Mio Slice, along with instructions on how to utilize the device.

They will register on line with PAI Health, and will be asked to sync their device at least once every 7 days. They will be encouraged to look at the device app on their smart phone at least once daily.

After 1 week of obtaining baseline data, subjects will be encouraged to try to obtain a PAI score of at least 30 initially. Once they obtain a score of 30 consistently, they will be encouraged to increase the score toward 50. If they consistently obtain 50, they can increase their goal sequentially toward a maximum goal of 100. The duration of the study will be 12 weeks.





Primary Outcome Measures :
  1. App utility [ Time Frame: 12 weeks ]
    ease in use of obtaining and using PAI score by the patient based on a patient survey


Secondary Outcome Measures :
  1. Systolic blood pressure [ Time Frame: 12 weeks ]
    change in systolic blood pressure

  2. Diastolic blood pressure [ Time Frame: 12 weeks ]
    change in diastolic blood pressure

  3. Weight [ Time Frame: 12 weeks ]
    change in weight

  4. Personal Activity Intelligence (PAI) Score [ Time Frame: 12 weeks ]
    The Personal Activity Intelligence (PAI) Score is a proprietary calculation owned by PAI Health, and not made available to the investigator. The score does take in to account resting heart rate while sleeping, peak heart rate during physical activity, length of time of elevated heart rate, steps. This data is captured via a wearable device, Mio Slice which is synced with a smart phone. Participants are encouraged to keep their PAI Score at 100, or as high as possible.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients who are seen by the PI in his lifestyle medicine practice at Muntean Health Care.
  • Participants must own a smart phone and feel comfortable managing apps on their smart phone.
  • Participants must be willing and able to register online with PAI Health (PH)
  • Participants must be willing to wear a wrist device around the clock, except when charging or bathing for 12 weeks.
  • Participants must have at least one of the following diagnoses:
  • overweight / obesity
  • diabetes or prediabetes
  • hypertension or pre-hypertension
  • abnormal lipids
  • cardiovascular disease

Exclusion Criteria:

  • Patients with angina or poor exercise tolerance, based on the evaluation by the PI, will be excluded from the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740074


Contacts
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Contact: David S Drozek, DO 678-447-2509 drozek@ohio.edu

Locations
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United States, Ohio
Ohio University Recruiting
Athens, Ohio, United States, 45701
Contact: David S Drozek, DO    678-447-2509    drozek@ohio.edu   
Principal Investigator: David S Drozek, DO         
Sponsors and Collaborators
Ohio University
Investigators
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Principal Investigator: David S Drozek, DO Ohio University

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Responsible Party: David Drozek, Associate Professor, Ohio University
ClinicalTrials.gov Identifier: NCT03740074     History of Changes
Other Study ID Numbers: 18-X-263
First Posted: November 14, 2018    Key Record Dates
Last Update Posted: November 14, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dyslipidemias
Overweight
Cardiovascular Diseases
Body Weight
Signs and Symptoms
Lipid Metabolism Disorders
Metabolic Diseases