Distributed Registry

NCT03898570 | Completed

• 1 other identifier: IRB-47517
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Patients undergoing vascular surgery procedures

Patients will report outcomes via their smartphone.

Behavioral: Patient reported outcomes

Interventions

Patient reported outcomes BEHAVIORAL

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

Patients undergoing vascular surgery procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead
• AstraZeneca: collaborator

Study Sites (2)

Palo Alto Veterans Hospital

Palo Alto, California, 94305, United States

Location

Stanford

Palo Alto, California, 94588, United States

Location

MeSH Terms

Conditions

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

Interventions

Patient Reported Outcome Measures

Condition Hierarchy (Ancestors)

Pathological Conditions, Signs and Symptoms; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Health Care Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Services Research; Health Planning; Health Care Economics and Organizations; Patient Outcome Assessment; Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health

Study Officials

• Oliver O Aalami, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2019
• First Posted: April 2, 2019
• Study Start: April 1, 2019
• Primary Completion: September 30, 2019
• Study Completion: March 1, 2021
• Last Updated: May 10, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)