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Personal Activity Intelligence (PAI) Pilot

Sponsor
Ohio University (Other)
Overall Status
Completed
CT.gov ID
NCT03740074
Collaborator
(none)
15
Enrollment
1
Location
1
Arm
14.9
Actual Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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
  • Behavioral: PAI
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective pilotProspective pilot
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Evaluation of Personal Activity Intelligence (PAI) Score Pilot Study
Actual Study Start Date :
Oct 2, 2018
Actual Primary Completion Date :
Jun 30, 2019
Actual Study Completion Date :
Dec 31, 2019

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. App utility [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 [12 weeks]

    change in systolic blood pressure

  2. Diastolic blood pressure [12 weeks]

    change in diastolic blood pressure

  3. Weight [12 weeks]

    change in weight

  4. Personal Activity Intelligence (PAI) Score [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ohio University Athens Ohio United States 45701

Sponsors and Collaborators

  • Ohio University

Investigators

  • Principal Investigator: David S Drozek, DO, Ohio University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
David Drozek, Associate Professor, Ohio University
ClinicalTrials.gov Identifier:
NCT03740074
Other Study ID Numbers:
  • 18-X-263
First Posted:
Nov 14, 2018
Last Update Posted:
Sep 16, 2020
Last Verified:
Sep 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cardiovascular Diseases
Dyslipidemias
Overweight

Study Results

No Results Posted as of Sep 16, 2020