Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT)

Completed

Conditions studied: Peripheral Arterial Disease, Quality of Life, Quality of Care

In brief

An estimated 8 million individuals in America are affected by peripheral arterial disease (PAD), blockages of the leg arteries that can cause excruciating calf pain when walking. PAD can have a tremendous impact on patients' quality of life. It is also associated with high rates of heart attacks and premature death. While there are a number of treatments, there have been few previous studies that have prospectively examined treatment patterns for PAD or sought to systematically identify opportunities to improve care. Most importantly, there have been no rigorous studies examining the impact of the disease from patients' perspectives - their symptoms, function and quality of life - as a function of different patient characteristics and treatments. The PORTRAIT study (Phase II) will systematically document the treatments and health status (symptom, function and quality of life) outcomes of 840 US patients over the course of one year (assessments at baseline, 3, 6, and 12 months) from 10 centers to address these gaps in knowledge. It will illuminate whether disparities in treatment or health status outcomes exist as a function of patients' age, gender, race, socioeconomic or psychological characteristics. PORTRAIT will substantially elevate the field and identify critical gaps in the way PAD is currently managed, including potential disparities in care, so that the quality of care can be improved.

Key facts

Study ID

NCT01419080

Run by

Saint Luke's Health System

People needed

797

Starts

2013-10-01

Expected to finish

2016-12-01

Last updated by the study team

2025-10-24

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 21 years
• New or recent exacerbation of exertional leg symptoms
• Resting ankle-brachial index assessment ≤0.90 or drop in post-exercise ankle pressure ≥20 mmHg

You may not qualify if…

• Non-compressible ankle-brachial index (≥1.30)
• Critical limb ischemia
• Lower-limb endovascular or surgical vascular procedure in past year
• Not speaking either English or Spanish
• Hearing impaired
• Unable to provide written informed consent
• Currently a prisoner

Where it is running

• Bridgeport Hospital — Bridgeport, Connecticut, United States
• Yale University — New Haven, Connecticut, United States
• Ochsner Health System — New Orleans, Louisiana, United States
• Saint Joseph Mercy Hospital — Ann Arbor, Michigan, United States
• Truman Medical Center — Kansas City, Missouri, United States
• Saint Luke's Hospital of Kansas City — Kansas City, Missouri, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• Rhode Island Hospital — Providence, Rhode Island, United States
• Miriam Hospital — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.