PAD Registry and Fitbit Sub-Study Program

NCT03446014 | Completed

• 1 other identifier: 817194
• Study Type: observational
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

The genetic contribution and influence on the progression of peripheral artery disease (PAD) and possible cardiovascular events remains relatively unknown. As a result, the investigators are proposing for the creation of a registry of patients in the University of Pennsylvania Health System who are known to have PAD. The patients in this registry will be systematically monitored by conducting lower extremity ultrasound exams, ankle-brachial index (ABI) measurements, and six minute walk tests which have strong value in the positive diagnoses of PAD. These exams, combined with follow-up quality of life questionnaires, would allow for thorough monitoring of new diagnoses, symptoms, or serious adverse events. Blood will also be drawn looking for genetic biomarkers associated with this disease, which will provide further knowledge on the advancement and potential cardiovascular events associated with this disease. This blood will also be analyzed for components that will provide the investigators with knowledge of the patients overall blood vessel health. Micro RNA will also be evaluated to try to test if proteins and RNA in the blood can be used as predictors for future strokes or heart attacks. These exams will be repeated once annually over a duration of 10 years, with patients having hemodynamic monitoring as well as quality-of-life and cardiovascular events recorded at each visit. The data obtained from this registry will be compared to a created genetic profile looking for any genetic contribution to these new developments. Furthermore, this knowledge should offer impetus for physicians to target patients with these risk factors for the identification of potential adjustments to care.

Conditions

Peripheral Artery Disease

Outcome Measures

Primary Outcomes (1)

• Registry creation of patients with known PAD

  Patients will be recruited from the University of Pennsylvania Health System via surveying of physician's clinics and various databases. Appropriate clinical staff will be informed of this study and its requirements prior to a patient's enrollment. As a result, routine care or other medical procedures of the patient will not be interfered with.

  10 Years

Secondary Outcomes (1)

• Patient walking distance

  1 Year

Other Outcomes (2)

• Genetic and Vascular Testing of Patients

  10 Years

• Systematically Monitoring Patients

  10 Years

Study Arms (2)

Control Group for Fitbit Sub-Study

Patient will be given Fitbit device, but will have no access to Fitbit website or interface. The coordinator will set up the patient's Fitbit on the office computer and will have access to the fitbit's associated username and password (this will be generated by the coordinator). The patient will be instructed to walk as much as they can each day, and to check the Fitbit wrist band periodically throughout the day to view their walking progress. At the end of the three month intervention, the patient will complete questionnaires and undergo a repeat 6 minute walk test.

Device: Fitbit Sub-Study

Intervention Group for Fitbit Sub-Study

Patient will be given the Fitbit device and instructed on how to use it. They will be given their username and password to the Fitbit device, and instructed on how to interact with other patients in the study as well as the coordinator on the Fitbit website. The coordinator will also show the patient how to install the application on a smart phone device and use the device via smartphone. The patient will then be instructed to walk as far as they can each day for a period of 12 weeks. Patients will check their steps daily and interact with other patients who participate in the study. Patients will return for a 3 month follow-up appointment where they will undergo a redo 6 minute walk test and questionnaires.

Device: Fitbit Sub-Study

Interventions

Fitbit Sub-Study DEVICE

Control Group for Fitbit Sub-Study; Intervention Group for Fitbit Sub-Study

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Peripheral Artery Disease is a disease that is highly prevalent within the United States, affecting close to 8-12 million individuals. These individuals' qualities of life are likely impaired due to limited walking ability, shortness of breath, and claudication. In addition, it is well known that risk factors such as smoking, diabetes mellitus, hypertension, and dyslipidemia can play a role in the onset of this disease

Sponsors & Collaborators

• University of Pennsylvania: lead

Study Sites (1)

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Emile R Mohler, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: February 26, 2018
• Study Start: January 1, 2013
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: April 4, 2019

Record last verified: 2019-04

Locations

US (1)