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Distributed Registry

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ClinicalTrials.gov Identifier: NCT03898570
Recruitment Status : Recruiting
First Posted : April 2, 2019
Last Update Posted : May 6, 2019
Sponsor:
Collaborator:
AstraZeneca
Information provided by (Responsible Party):
Oliver O. Aalami, Stanford University

Brief Summary:
The purpose of this study is to test if a patient can be directly connected to a quality assurance (QA) database, traditionally known as a registry. Patient-reported outcomes (PRO) data will be entered into the database directly from a patient's mobile phone from their index procedure for 12 months. The investigators hope this study to be a "proof of concept" for such a distributed registry and evaluate 1) consistency of data acquisition, 2) engagement of patients, 3) overall value of patient-reported outcomes to enhance long term follow up.

Condition or disease Intervention/treatment
Peripheral Arterial Disease Intermittent Claudication Arteriosclerosis Atherosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases Signs and Symptoms Patient Compliance Behavioral: Patient reported outcomes

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 12 Months
Official Title: Distributed Registry Study
Actual Study Start Date : April 1, 2019
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : December 31, 2019

Group/Cohort Intervention/treatment
Patients undergoing vascular surgery procedures
Patients will report outcomes via their smartphone.
Behavioral: Patient reported outcomes

Patients will download the research app onto their phone and enter pertinent medical history and surgical history data similar to standard registries for specific procedures. Over the next 12 months the investigators will obtain patient-reported outcomes (PROs) using the patient's phone.

Specifically, the investigators will obtain daily activity data, weekly 6-minute-walk tests, and quarterly quality of life surveys





Primary Outcome Measures :
  1. Patient Reported Outcomes (PROs) using mobile app [ Time Frame: 1 Year ]
    PROs are any report of the status of a patient's health condition that comes directly from the patient, without interpretation of the patient's response by a clinician or anyone else



Information from the National Library of Medicine

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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:

  1. Patients with cardiovascular disease who are scheduled or have undergone either a) open or endovascular vascular procedure, or b) open or percutaneous cardiac procedure.
  2. Patients with smartphones (iOS or Android) with unlimited data plans.
  3. Patients who agree to remote surveillance

Exclusion Criteria:

  1. Patients unwilling to download a research study app.
  2. Data plans which are not unlimited.

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): NCT03898570


Contacts
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Contact: Doran S Triggs, BS 6508523459 ext 63459 dorant@stanford.edu
Contact: Helle N Nielsen, MPH 6505972031 hnnb@stanford.edu

Locations
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United States, California
Palo Alto Veterans Hospital Recruiting
Palo Alto, California, United States, 94305
Contact: Doran S Triggs, BS    650-852-3459    dorant@stanford.edu   
Stanford Recruiting
Palo Alto, California, United States, 94588
Contact: Doran S Triggs, BS    650-852-3459    dorant@stanford.edu   
Sponsors and Collaborators
Stanford University
AstraZeneca
Investigators
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Principal Investigator: Oliver O Aalami, MD Stanford University

Additional Information:

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Responsible Party: Oliver O. Aalami, CLINICAL ASSOCIATE PROFESSOR, SURGERY - VASCULAR SURGERY, Stanford University
ClinicalTrials.gov Identifier: NCT03898570     History of Changes
Other Study ID Numbers: IRB-47517
First Posted: April 2, 2019    Key Record Dates
Last Update Posted: May 6, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Vascular Diseases
Peripheral Arterial Disease
Peripheral Vascular Diseases
Intermittent Claudication
Signs and Symptoms
Arteriosclerosis
Arterial Occlusive Diseases