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
|Condition or disease||Intervention/treatment||Phase|
|Overweight and Obesity Diabetes Hypertension Dyslipidemias Cardiovascular Diseases||Behavioral: PAI||Not Applicable|
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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Prospective pilot|
|Masking:||None (Open Label)|
|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|
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.
- App utility [ Time Frame: 12 weeks ]ease in use of obtaining and using PAI score by the patient based on a patient survey
- Systolic blood pressure [ Time Frame: 12 weeks ]change in systolic blood pressure
- Diastolic blood pressure [ Time Frame: 12 weeks ]change in diastolic blood pressure
- Weight [ Time Frame: 12 weeks ]change in weight
- 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.
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
|Contact: David S Drozek, DOfirstname.lastname@example.org|
|United States, Ohio|
|Athens, Ohio, United States, 45701|
|Contact: David S Drozek, DO 678-447-2509 email@example.com|
|Principal Investigator: David S Drozek, DO|
|Principal Investigator:||David S Drozek, DO||Ohio University|