Distributed Registry

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Behavior Cardiovascular Diseases Health Behavior Intermittent Claudication Pathological Conditions, Signs and Symptoms Patient Acceptance of Health Care Patient Compliance Peripheral Vascular Diseases Signs and Symptoms Treatment Adherence and Compliance Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Palo Alto Veterans Hospital, Palo Alto, California, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Exclusion criteria

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

Treatment and study plan

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

Primary outcomes

Patient Reported Outcomes (PROs) using mobile app

Time frame: 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

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

AstraZeneca

Registry information

Official study title

Distributed Registry Study

Important dates

Study start: 2019
Primary completion: 2019
Study completion: 2021
First posted: Apr 2, 2019
Registry last updated: May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed