Distributed Registry

Stanford University

Status: Completed

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

Treatments: Behavioral: Patient reported outcomes

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT03898570

IRB-47517

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Patients undergoing vascular surgery procedures

Description:

Patients will report outcomes via their smartphone.

Treatment:

Behavioral: Patient reported outcomes