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Distributed Registry

NCT03898570 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2023-05-10

No results posted yet for this study

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.

Conditions

  • Peripheral Arterial Disease
  • Intermittent Claudication
  • Arteriosclerosis
  • Atherosclerosis
  • Arterial Occlusive Diseases
  • Vascular Diseases
  • Cardiovascular Diseases
  • Peripheral Vascular Diseases
  • Signs and Symptoms
  • Patient Compliance

Interventions

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

Sponsors & Collaborators

Principal Investigators

  • Oliver O Aalami, MD · Stanford University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-01
Primary Completion
2019-09-30
Completion
2021-03-01

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03898570 on ClinicalTrials.gov