NCT03898570

Distributed Registry

Distributed Registry Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2019-04-01
• Primary completion: 2019-09-30
• Completion: 2021-03-01
• First posted: 2019-04-02
• Last updated: 2023-05-10

Locations

2 sites across 1 country: United States