VascTrac Peripheral Arterial Disease (PAD) Study (VascTrac)

November 2, 2022 updated by: Oliver Aalami, Palo Alto Veterans Institute for Research

VascTrac PAD ResearchKit Study

VascTrac is a mobile medical application that tracks users' physical activity levels in order to predict endovascular failure of patients with Peripheral Artery Disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

VascTrac uses open-source software from Apple's ResearchKit to passively track physical activity levels of users who sign up. The goal is to predict post-intervention endovascular failure before it occurs. Currently, physicians have no way of knowing when procedures such as angioplasties fail; with VascTrac, researchers hope to find downward trends in physical activity that will predict and indicate endovascular failure. All users are assigned numbers and their medical data is securely coded, decreasing the risk of promulgation of personal information.

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94304
        • Recruiting
        • VA Palo Alto Health Care System
        • Contact:
        • Sub-Investigator:
          • Oliver O Aalami, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All adults with an iPhone 5s or higher who can read English

Description

Inclusion Criteria:

  • adult, has iPhone 5s, can read English

Exclusion Criteria:

  • under 18 years

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with PAD
Patients with PAD will be in 1 cohort and will have their physical activity levels closely monitored by researchers and physicians.
Behavioral: Physical activity levels
Patients with severely low physical activity levels will be notified to consult their physician.
Patients without PAD
Patients without PAD will be allowed to contribute their data to the application, but they will not be as closely monitored.
Behavioral: Physical activity levels
Patients with severely low physical activity levels will be notified to consult their physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Activity
Time Frame: Two Years
Participants will have their physical activity measured and recorded by the devices in Apple's Health application.
Two Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Palo Alto Veterans Institute for Research

Collaborators

W.L.Gore & Associates
Boston Scientific Corporation
Abbott
Cook Group Incorporated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2017

Primary Completion (ANTICIPATED)

December 1, 2023

Study Completion (ANTICIPATED)

December 1, 2023

Study Registration Dates

First Submitted

September 6, 2016

First Submitted That Met QC Criteria

February 7, 2017

First Posted (ESTIMATE)

February 9, 2017

Study Record Updates

Last Update Posted (ACTUAL)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAL0001ARG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

If users consent, their data may or may not be shared with their personal physicians for direct patient care.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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