Community-Based Detection and Treatment of Peripheral Arterial Disease in Hispanics.
| Status: | Completed |
|---|---|
| Conditions: | Peripheral Vascular Disease |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 70 - Any |
| Updated: | 4/21/2016 |
| Start Date: | February 2008 |
| End Date: | February 2013 |
Peripheral Arterial Disease (PAD) is a highly prevalent public health problem that results
from progressive atherosclerosis of arteries in the lower extremities. PAD is also
associated with major detrimental effects on quality of life and functional status, and is
the most important cause of limb amputation. More importantly, PAD is a major manifestation
of cardiovascular disease and a potent predictor of myocardial infarction, stroke and death.
Despite its frequent occurrence, little is known about the natural history of PAD in
Hispanics who represent 12.5% of the United States. Because access to health care is limited
among Hispanics, CBPR is the ideal process to reach this target population. The goal of the
proposed study is to evaluate community-based strategies of detection and treatment of
peripheral arterial disease (PAD) in Hispanics. The proposed project consists of two phases:
a cross-sectional phase (PAD detection), followed by a randomization phase.During the PAD
detection study , the prevalence and severity of PAD in this population will be determined.
Specific risk factors associated with PAD among the Hispanic participants will be
identified. During the second phase patients will be enrolled in a randomized, non-blinded
trial comparing a community-based risk factor modification and supervised exercise program
versus usual care for PAD. These individuals will undergo a baseline evaluation similar to
the one obtained during the first phase of the study, but will also include functional
testing of the lower extremities.
from progressive atherosclerosis of arteries in the lower extremities. PAD is also
associated with major detrimental effects on quality of life and functional status, and is
the most important cause of limb amputation. More importantly, PAD is a major manifestation
of cardiovascular disease and a potent predictor of myocardial infarction, stroke and death.
Despite its frequent occurrence, little is known about the natural history of PAD in
Hispanics who represent 12.5% of the United States. Because access to health care is limited
among Hispanics, CBPR is the ideal process to reach this target population. The goal of the
proposed study is to evaluate community-based strategies of detection and treatment of
peripheral arterial disease (PAD) in Hispanics. The proposed project consists of two phases:
a cross-sectional phase (PAD detection), followed by a randomization phase.During the PAD
detection study , the prevalence and severity of PAD in this population will be determined.
Specific risk factors associated with PAD among the Hispanic participants will be
identified. During the second phase patients will be enrolled in a randomized, non-blinded
trial comparing a community-based risk factor modification and supervised exercise program
versus usual care for PAD. These individuals will undergo a baseline evaluation similar to
the one obtained during the first phase of the study, but will also include functional
testing of the lower extremities.
Inclusion Criteria:
Cross-Sectional phase:
- Hispanic men and women aged 70 years or older.
- Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
- Individual has been informed of the nature, procedures and risks of the study, and
has signed a consent form approved by UT Southwestern Institutional Review Board.
Randomization phase:
- Hispanic men and women aged 70 years or older
- English or Spanish speaking
- Hispanic participants with diabetes mellitus or smokers aged 50 through 69 years.
- Documented peripheral arterial disease with an Ankle-brachial index (ABI) < 0.9 or
Toe-brachial index (TBI) <0.7, and abnormal Pulse Volume Recordings (PVR).
- Ability to ambulate independently.
- No prior amputations other than toe or partial foot amputations that do not impede
walking.
- Patient has been informed of the nature, procedures and risks of the study, and has
signed a consent form approved by the UT Southwestern Institutional Review Board.
Exclusion Criteria:
Cross-Sectional Phase
- Individuals with severe dementia.
- Individuals with inability to provide informed consent.
- Bilateral lower or upper extremities amputations.
- Pregnancy or lactation. Randomization Phase
- Non-ambulatory
- Individuals with prior below- or above-knee amputations
- Individuals unable to give informed consent
- Individuals unwilling to perform the functional tests or quality of life assessments
- Individuals unable to perform exercise therapy, functional tests or quality of life
assessments due to severe comorbidities
- Presence of concurrent illness with an anticipated life expectancy less than six
months
- Individuals with planned operative interventions
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