Distributed Registry

Distributed Registry Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03898570

Enrollment

100

Registered

2019-04-02

Start date

2019-04-01

Completion date

2021-03-01

Last updated

2023-05-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

BEHAVIORALPatient 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

Study design

Observational model

CASE_ONLY

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026