Personal Activity Intelligence (PAI) Pilot (PAI)
Evaluation of Personal Activity Intelligence (PAI) Score Pilot Study
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Athens, Ohio, United States, 45701
- Ohio University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
App utility
Time Frame: 12 weeks
|
ease in use of obtaining and using PAI score by the patient based on a patient survey
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Systolic blood pressure
Time Frame: 12 weeks
|
change in systolic blood pressure
|
12 weeks
|
|
Diastolic blood pressure
Time Frame: 12 weeks
|
change in diastolic blood pressure
|
12 weeks
|
|
Weight
Time Frame: 12 weeks
|
change in weight
|
12 weeks
|
|
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.
|
12 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 18-X-263
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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