Quality of Life Clinical Trial
— PORTRAITOfficial title:
Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT Registry)
Verified date | June 2023 |
Source | Saint Luke's Health System |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Active, not recruiting |
Enrollment | 797 |
Est. completion date | December 2024 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Saint Joseph Mercy Hospital | Ann Arbor | Michigan |
United States | Bridgeport Hospital | Bridgeport | Connecticut |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Duke University Medical Center | Durham | North Carolina |
United States | Saint Luke's Hospital of Kansas City | Kansas City | Missouri |
United States | Truman Medical Center | Kansas City | Missouri |
United States | Yale University | New Haven | Connecticut |
United States | Ochsner Health System | New Orleans | Louisiana |
United States | Miriam Hospital | Providence | Rhode Island |
United States | Rhode Island Hospital | Providence | Rhode Island |
Lead Sponsor | Collaborator |
---|---|
Saint Luke's Health System | Patient-Centered Outcomes Research Institute |
United States,
Steg PG, Bhatt DL, Wilson PW, D'Agostino R Sr, Ohman EM, Rother J, Liau CS, Hirsch AT, Mas JL, Ikeda Y, Pencina MJ, Goto S; REACH Registry Investigators. One-year cardiovascular event rates in outpatients with atherothrombosis. JAMA. 2007 Mar 21;297(11):1197-206. doi: 10.1001/jama.297.11.1197. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Peripheral Artery Disease (PAD) - Specific Health Status | Scores on a scale of 0-100 with higher scores representing better health status (0= worst health imaginable, 100= best health imaginable). Subscales are weighed in a standardized scoring algorithm (proprietary). Measures symptoms, symptom stability, and quality of life. | One Year | |
Secondary | All-cause Mortality | all-cause mortality | One Year |
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