Latinos Understanding the Need for Adherence
LUNA
San Diego Partnership to Reduce Diabetes & Cardiovascular Disease in Latinos
1 other identifier
interventional
587
1 country
1
Brief Summary
The Latino population in the United States is increasing in size; is diverse in culture, backgrounds and countries of origin; is experiencing unique influences from social and behavioral acculturation to the U.S.; is reported nationally to have lower rates of heart disease; is reported to have increased prevalence of diabetes and asthma; and is generally poorer and less educated (NHLBI working Group, 2003). They represent an important target population for disparities research. In particular Latinos accessing care in Community Health Centers in the United States represent an ideal population for conducting disparities research because lack of access to care is minimized through various governmental health insurance support mechanisms. This study will build on existing relationships to conduct the proposed study, using expertise in epidemiologic, behavioral and genetic research in an effort to promote a coordinated, comprehensive, interdisciplinary and focused research effort to improve the care being delivered to indigent Latinos at-risk for and with CVD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2013
CompletedFirst Posted
Study publicly available on registry
November 4, 2016
CompletedNovember 4, 2016
November 1, 2016
4.2 years
July 17, 2012
November 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in Carotid Intimal Medial Thickness (CIMT) Measurement
The CIMT measurement measures the thickness of the inner two layers of the carotid artery. The special intervention arm of this randomized trial is designed to modify multiple, modifiable cardiovascular risk factors that affect atherosclerosis and can be measured by sonography of the carotid intimal thickness.
Baseline and 24-months
Secondary Outcomes (1)
Medication Adherence
Baseline and every 6-months for a maximum of 2-years
Study Arms (2)
Special Intervention
EXPERIMENTALThe Special Intervention (SI) is designed to modify multiple, modifiable CVD risk factors that affect atherosclerosis and can be measured by sonography of the carotid intimal thickness. The SI is designed to address multiple, modifiable CVD risk factors that involve medication therapy, including hypertension, diabetes, and dyslipidemia.
Usual Care
NO INTERVENTIONUsual care (UC) reflects current practices by the primary care providers in the adult medicine department. Participants randomized into the UC group will continue with their regular medical visits and referrals to the health educator as they were before randomization.
Interventions
Participants randomized into the SI group will participate in four group health education classes and seven clinical visits per year with the "patient care team". The patient care team will be comprised of a mid-level clinician and a Community Health Worker (CHW). Content and materials utilized in the group health education classes are derived from the validated and translated curriculum Pasos Adelante , developed and refined by the CDC. Methods for training CHWs will be derived from the Pasos Adelante Curriculum.
Eligibility Criteria
You may qualify if:
- be of Hispanic/Latino ethnicity
- be a registered patient at the SYHC, Inc.
- be at least 40 years of age or older
- have one or more modifiable CVD risk factors, which are defined here as: high LDL cholesterol (non-diabetic threshold = \> 160 mg/dl, diabetic threshold = \> 130 mg/dl), low HDL cholesterol (\<40 mg/dl), Obesity (BMI \> 30 kg/m2), Cigarette smoking (daily smoker), Diabetes (fasting blood glucose \> 126, self-reported and/or confirmed from chart review), and Hypertension (BP \> 140/90 mmHg, or on hypertensive meds); and 5) not be currently participating in any other CVD program.
You may not qualify if:
- planning to move out of the area in the next six months
- have health problems, disabilities, or mental problems so severe as to prohibit informed consent and actual clinic/special intervention attendance. The most common abnormality that will be found on the ultrasound scans (CIMT) is extensive carotid disease. For some individuals, this may make examination of the carotid arteries very difficult. Thus, individuals will be excluded if 4) there is extensive carotid disease that precludes an accurate assessment of CIMT.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
South Bay Latino Research Center
Chula Vista, California, 91910, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gregory Talavera, MD/MPH
San Diego State University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor & Division Head-Health Promotion/Behavioral Science Graduate School of Public Health
Study Record Dates
First Submitted
July 17, 2012
First Posted
November 4, 2016
Study Start
August 1, 2009
Primary Completion
October 1, 2013
Study Completion
October 1, 2013
Last Updated
November 4, 2016
Record last verified: 2016-11
Data Sharing
- IPD Sharing
- Will not share