N/A
N=797
Patient-centered Outcomes Related to TReatment Practices in Peripheral Arterial Disease: Investigating Trajectories (PORTRAIT)
Peripheral Arterial Disease · Quality of Life · Quality of Care
Bottom Line
View on ClinicalTrials.gov: NCT01419080 ↗Enrolled (actual)
797
Serious AEs
3.8%
Results posted
Jul 2019
Primary outcome: Primary: Peripheral Artery Disease (PAD) - Specific Health Status — 70.7; 66.9 units on a scale of 0-100
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Saint Luke's Health System
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peripheral Artery Disease (PAD) - Specific Health Status |
70.7; 66.9 | — |
| SECONDARY All-cause Mortality |
30 | — |
Summary
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT01419080). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.