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VascTrac Peripheral Arterial Disease (PAD) Study (VascTrac)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03048890
Recruitment Status : Unknown
Verified February 2017 by Oliver Aalami, Palo Alto Veterans Institute for Research.
Recruitment status was:  Not yet recruiting
First Posted : February 9, 2017
Last Update Posted : February 23, 2017
Sponsor:
Collaborators:
Stanford Center for Clinical & Translational Research & Education
Gore
Abbott
Cook Group Incorporated
Information provided by (Responsible Party):
Oliver Aalami, Palo Alto Veterans Institute for Research

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

Condition or disease Intervention/treatment
Peripheral Artery Disease Intermittent Claudication Behavioral: Physical activity levels

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.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: VascTrac PAD ResearchKit Study
Estimated Study Start Date : March 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Physical Activity [ Time Frame: Two Years ]
    Participants will have their physical activity measured and recorded by the devices in Apple's Health application.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All adults with an iPhone 5s or higher who can read English
Criteria

Inclusion Criteria:

  • adult, has iPhone 5s, can read English

Exclusion Criteria:

  • under 18 years

Information from the National Library of Medicine

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): NCT03048890


Contacts
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Contact: Oliver O Aalami, MD 650-852-3451 aalami@stanford.edu

Sponsors and Collaborators
Palo Alto Veterans Institute for Research
Stanford Center for Clinical & Translational Research & Education
Gore
Abbott
Cook Group Incorporated
Investigators
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Principal Investigator: Oliver O Aalami, MD Stanford University

Publications:

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Responsible Party: Oliver Aalami, Principal Investigator, Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier: NCT03048890    
Other Study ID Numbers: AAL0001ARG
First Posted: February 9, 2017    Key Record Dates
Last Update Posted: February 23, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: If users consent, their data may or may not be shared with their personal physicians for direct patient care.
Keywords provided by Oliver Aalami, Palo Alto Veterans Institute for Research:
PAD
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Intermittent Claudication
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Signs and Symptoms