Distributed Registry

Distributed Registry Study

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.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Atherosclerosis; Intermittent Claudication; Signs and Symptoms; Patient Compliance
• Intervention / Treatment: Behavioral: Patient reported outcomes

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94305
      • Palo Alto Veterans Hospital
    • Palo Alto, California, United States, 94588
      • Stanford

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes (PROs) using mobile app	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	1 Year

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Oliver O Aalami, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): September 30, 2019
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: March 29, 2019
• First Submitted That Met QC Criteria: March 29, 2019
• First Posted (Actual): April 2, 2019

Study Record Updates

• Last Update Posted (Actual): May 10, 2023
• Last Update Submitted That Met QC Criteria: May 8, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Intermittent Claudication; Arterial Occlusive Diseases; Arteriosclerosis; Atherosclerosis
• Other Study ID Numbers: IRB-47517

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No