VascTrac Peripheral Arterial Disease (PAD) Study
Sponsor
Palo Alto Veterans Institute for Research (Other)
Overall Status
Recruiting
CT.gov ID
NCT03048890
Collaborator
Gore (Other), Abbott (Industry), Cook Group Incorporated (Industry), Boston Scientific Corporation (Industry)
2,000
1
69
29
Study Details
Study Description
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 | Phase |
|---|---|---|
|
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 Design
Study Type:
Observational
Anticipated Enrollment
:
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
VascTrac PAD ResearchKit Study
Actual Study Start Date
:
Mar 1, 2017
Anticipated Primary Completion Date
:
Dec 1, 2021
Anticipated Study Completion Date
:
Dec 1, 2022
Arms and Interventions
| Arm | 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.
|
Outcome Measures
Primary Outcome Measures
- Physical Activity [Two Years]
Participants will have their physical activity measured and recorded by the devices in Apple's Health application.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
- adult, has iPhone 5s, can read English
Exclusion Criteria:
- under 18 years
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | VA Palo Alto Health Care System | Palo Alto | California | United States | 94304 |
Sponsors and Collaborators
- Palo Alto Veterans Institute for Research
- Gore
- Abbott
- Cook Group Incorporated
- Boston Scientific Corporation
Investigators
- Principal Investigator: Oliver O Aalami, MD, Stanford University
Study Documents (Full-Text)
None provided.More Information
Publications
- Afaq A, Patel JH, Gardner AW, Hennebry TA. Predictors of change in walking distance in patients with peripheral arterial disease undergoing endovascular intervention. Clin Cardiol. 2009 Sep;32(9):E7-11. doi: 10.1002/clc.20553.
- Carter T, O'Neill S, Johns N, Brady RR. Contemporary vascular smartphone medical applications. Ann Vasc Surg. 2013 Aug;27(6):804-9. doi: 10.1016/j.avsg.2012.10.013. Epub 2013 Mar 25.
- Coughlin PA, Kent PJ, Turton EP, Byrne P, Berridge DC, Scott DJ, Kester RC. A new device for the measurement of disease severity in patients with intermittent claudication. Eur J Vasc Endovasc Surg. 2001 Dec;22(6):516-22.
- Cunningham MA, Swanson V, Pappas E, O'Carroll RE, Holdsworth RJ. Illness beliefs and walking behavior after revascularization for intermittent claudication: a qualitative study. J Cardiopulm Rehabil Prev. 2014 May-Jun;34(3):195-201. doi: 10.1097/HCR.0000000000000046.
- Gernigon M, Le Faucheur A, Fradin D, Noury-Desvaux B, Landron C, Mahe G, Abraham P. Global positioning system use in the community to evaluate improvements in walking after revascularization: a prospective multicenter study with 6-month follow-up in patients with peripheral arterial disease. Medicine (Baltimore). 2015 May;94(18):e838. doi: 10.1097/MD.0000000000000838.
- Malgor RD, Alahdab F, Elraiyah TA, Rizvi AZ, Lane MA, Prokop LJ, Phung OJ, Farah W, Montori VM, Conte MS, Murad MH. A systematic review of treatment of intermittent claudication in the lower extremities. J Vasc Surg. 2015 Mar;61(3 Suppl):54S-73S. doi: 10.1016/j.jvs.2014.12.007. Epub 2015 Feb 23. Review. Erratum in: J Vasc Surg. 2015 May;61(5):1382. Alalahdab, Fares [Corrected to Alahdab, Fares].
- Murphy TP, Cutlip DE, Regensteiner JG, Mohler ER, Cohen DJ, Reynolds MR, Massaro JM, Lewis BA, Cerezo J, Oldenburg NC, Thum CC, Goldberg S, Jaff MR, Steffes MW, Comerota AJ, Ehrman J, Treat-Jacobson D, Walsh ME, Collins T, Badenhop DT, Bronas U, Hirsch AT; CLEVER Study Investigators. Supervised exercise versus primary stenting for claudication resulting from aortoiliac peripheral artery disease: six-month outcomes from the claudication: exercise versus endoluminal revascularization (CLEVER) study. Circulation. 2012 Jan 3;125(1):130-9. doi: 10.1161/CIRCULATIONAHA.111.075770. Epub 2011 Nov 16.
- Murphy TP, Hirsch AT, Cutlip DE, Regensteiner JG, Comerota AJ, Mohler E, Cohen DJ, Massaro J; CLEVER Investigators. Claudication: exercise vs endoluminal revascularization (CLEVER) study update. J Vasc Surg. 2009 Oct;50(4):942-945.e2. doi: 10.1016/j.jvs.2009.04.076. Epub 2009 Aug 5.
- Murphy TP, Hirsch AT, Ricotta JJ, Cutlip DE, Mohler E, Regensteiner JG, Comerota AJ, Cohen DJ; CLEVER Steering Committee. The Claudication: Exercise Vs. Endoluminal Revascularization (CLEVER) study: rationale and methods. J Vasc Surg. 2008 Jun;47(6):1356-63. doi: 10.1016/j.jvs.2007.12.048. Epub 2008 Apr 25.
Responsible Party:
Oliver Aalami,
Principal Investigator,
Palo Alto Veterans Institute for Research
ClinicalTrials.gov Identifier:
NCT03048890
Other Study ID Numbers:
- AAL0001ARG
First Posted:
Feb 9, 2017
Last Update Posted:
Mar 18, 2020
Last Verified:
Mar 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Oliver Aalami,
Principal Investigator,
Palo Alto Veterans Institute for Research
Additional relevant MeSH terms: