Personal Activity Intelligence (PAI) Pilot

Hypertension Clinical Trial

— PAI  

Official title:

Evaluation of Personal Activity Intelligence (PAI) Score Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03740074
• Other study ID #: 18-X-263
• Status: Completed
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Ohio University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: December 31, 2019
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes
• Dyslipidemias
• Hypertension
• Overweight
• Overweight and Obesity

Intervention

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.

Locations

Country	Name	City	State
United States	Ohio University	Athens	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	App utility	ease in use of obtaining and using PAI score by the patient based on a patient survey	12 weeks
Secondary	Systolic blood pressure	change in systolic blood pressure	12 weeks
Secondary	Diastolic blood pressure	change in diastolic blood pressure	12 weeks
Secondary	Weight	change in weight	12 weeks
Secondary	Personal Activity Intelligence (PAI) Score	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