Distributed Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-04-01

Study Completion Date

2021-03-01

Brief Summary

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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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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients undergoing vascular surgery procedures

Patients will report outcomes via their smartphone.

Patient reported outcomes

Intervention Type 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

Interventions

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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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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