Distributed Registry

Cardiovascular Diseases Clinical Trial

Official title:

Distributed Registry Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898570
• Other study ID #: IRB-47517
• Status: Completed
• Start date: April 1, 2019
• Est. completion date: March 1, 2021

Study information

• Verified date: May 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 1, 2021
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
United States	Palo Alto Veterans Hospital	Palo Alto	California
United States	Stanford	Palo Alto	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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