Distributed Registry

Completed

• Conditions: Atherosclerosis; Peripheral Vascular Diseases; Signs and Symptoms; Arterial Occlusive Diseases; Cardiovascular Diseases; Patient Compliance; Peripheral Arterial Disease; Intermittent Claudication; Arteriosclerosis; Vascular Diseases
• Interventions: Behavioral: Patient reported outcomes

• Registration Number: NCT03898570
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-03-29
• Study First Submitted QC: 2019-03-29
• Study Start: 2019-04-01
• Study First Posted: 2019-04-02
• Primary Completion: 2019-09-30
• Study Completion: 2021-03-01
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-08
• Last Update Posted: 2023-05-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients undergoing vascular surgery procedures	Patient reported outcomes	Patients will report outcomes via their smartphone.

Primary Outcome Measures

Name	Time	Method
Patient Reported Outcomes (PROs) using mobile app	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

Trial Locations

Locations (2)

Palo Alto Veterans Hospital; 🇺🇸 Palo Alto, California, United States

Stanford; 🇺🇸 Palo Alto, California, United States