Distributed Registry

Sponsor

Stanford University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03898570

Collaborator

AstraZeneca (Industry)

100

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

5.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Intermittent Claudication Arteriosclerosis Atherosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Peripheral Vascular Diseases Signs and Symptoms Patient Compliance	Behavioral: Patient reported outcomes

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Cross-Sectional

Official Title:

Distributed Registry Study

Actual Study Start Date :

Apr 1, 2019

Anticipated Primary Completion Date :

Sep 30, 2019

Anticipated Study Completion Date :

Dec 31, 2019

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Patients with cardiovascular disease who are scheduled or have undergone either a) open or endovascular vascular procedure, or b) open or percutaneous cardiac procedure.
Patients with smartphones (iOS or Android) with unlimited data plans.
Patients who agree to remote surveillance