AtherosclerosisLUNANCT02955238
Latinos Understanding the Need for Adherence
A study testing Special Intervention in people with Atherosclerosis and High Blood Pressure, run by San Diego State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Atherosclerosis, High Blood Pressure, Type 2 Diabetes Mellitus
- What is being tested?
- Special Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 587 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Oct 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- are pregnant (temporary exclusion-may qualify six months post partum)
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
South Bay Latino Research Center
Chula Vista, California, 91910
About this study
Official title: San Diego Partnership to Reduce Diabetes & Cardiovascular Disease in Latinos
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.
Read the detailed description
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 cardiovascular disease (CVD). This study consists of three study visits:
Study Visit 1 (Sv1):
During Sv1, which lasts about 2 hours, potential participants are recruited and the consenting process is completed with those who wish to take part in the study. Participants then have their blood pressure taken and blood draw takes place. After the blood draw participants will be given a snack before completing the battery of psychosocial, health history and risk factor questionnaires. Lastly, standing height, weight and bioelectric impedance (Tanita scale) will be measured to determine BMI/obesity as a risk factor. At the end of Sv1 participants will be given the GT3X actigraph to objectively monitor their physical activity. Participants will be asked to wear the activity monitor for seven days and asked to return the monitor at the Sv3 appointment.
Chart Audit:
A chart audit will be performed by a research assistant (RA) before Sv3 in order to confirm eligibility and confirm medical history. Information from the chart may also lead to exclude individuals with deteriorated health status. If such a condition is detected the investigators will consult with the primary care provider for confirmation and adjudication before notifying the patient.
Study Visit 2 (Sv2):
The second study visit will take place in the form of a telephone call. After Sv1 a member of the research team will call participants to confirm eligibility and continued interest in the randomized controlled trial. If participants are still interested and eligible, they will continue with Sv3.
Study Visit 3 (Sv3):
The final study visit and randomization will take place at the LUNA field site, where the B-mode ultrasound machine will be stationed. During this time participants will have 1) the Carotid Intimal Medial Thickness (CIMT), the primary outcome, measured using non-invasive ultrasonography, 2) the difference in blood pressure between legs and arms, called Ankle Brachial Index (ABI), and 3) complete any outstanding/incomplete questionnaires from Sv1. During SV-3 the informed consent will be reviewed one more time. The physical measures of CIMT and ABI will be performed by trained technicians.
Also during Sv3, participants will be provided with Medication Event Monitoring System (MEMS) tracking caps. These caps will be used to objectively monitor participant adherence to their recommended chronic disease medications, either their lipid lowering, hypertensive or diabetes medication. In both groups it will provide the study with objective information on medication use behavior and for the intervention group the information serve as feedback to improve adherence to pill taking behavior.
Both control and experimental conditions will be asked to participate in the medication adherence study component, which will begin immediately after study group randomization. Participants' medication adherence will be monitored for one year including four prescription refill time points.
In addition to completing the comprehensive baseline assessments during SV-1 through SV-3, the extended screening period allows the participant time to consider and discuss their participation in the study. If participants have less than one defined CVD risk factors or refuse to participate in the RCT, they will be offered participation in the observational study (i.e. study in which only base-line measures and subsequent routine measures obtained during usual care will be analyzed). The observational group will serve as another comparison group for the overall chronic disease study.
- Conditions
- Atherosclerosis, High Blood Pressure, Type 2 Diabetes Mellitus, Heart Disease, Hypercholesterolemia
- Being tested
- Special Intervention
- Keywords
- Intervention, Cardiovascular Disease, CVD, Diabetes, Latinos, CIMT, Medication Adherence, Risk Factors, T2D
- Medical subject headings
- Atherosclerosis, Hypertension, Diabetes Mellitus, Type 2, Heart Diseases, Hypercholesterolemia, Cardiovascular Diseases, Diabetes Mellitus, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Special InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Special Intervention | Experimental | The 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. Receives: Behavioral: Special Intervention |
| Usual Care | No intervention | Usual 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 24-months
Secondary outcomes (1)
Medication Adherence
Medication adherence in measured using Medication Event Monitoring System (MEMS caps)
Measured: Baseline and every 6-months for a maximum of 2-years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study startAug 2009
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 587 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gregory Talavera, San Diego State University
- Investigators
- Gregory Talavera, MD/MPH, Principal investigator, San Diego State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955238
- Sponsor's protocol ID
- G00007349
- Acronym
- LUNA
- Status last verified
- Nov 2016
- First submitted
- 17 Jul 2012
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- San Diego Partnership to Reduce Diabetes & Cardiovascular Disease in Latinos
- ClinicalTrials.gov ID
- NCT02955238
- Acronym / sponsor ID
- LUNA / G00007349
- Conditions
- Atherosclerosis, High Blood Pressure, Type 2 Diabetes Mellitus, Heart Disease, Hypercholesterolemia
- Keywords
- Intervention, Cardiovascular Disease, CVD, Diabetes, Latinos, CIMT, Medication Adherence, Risk Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 587 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 cardiovascular disease (CVD). This study consists of three study visits:
Study Visit 1 (Sv1):
During Sv1, which lasts about 2 hours, potential participants are recruited and the consenting process is completed with those who wish to take part in the study. Participants then have their blood pressure taken and blood draw takes place. After the blood draw participants will be given a snack before completing the battery of psychosocial, health history and risk factor questionnaires. Lastly, standing height, weight and bioelectric impedance (Tanita scale) will be measured to determine BMI/obesity as a risk factor. At the end of Sv1 participants will be given the GT3X actigraph to objectively monitor their physical activity. Participants will be asked to wear the activity monitor for seven days and asked to return the monitor at the Sv3 appointment.
Chart Audit:
A chart audit will be performed by a research assistant (RA) before Sv3 in order to confirm eligibility and confirm medical history. Information from the chart may also lead to exclude individuals with deteriorated health status. If such a condition is detected the investigators will consult with the primary care provider for confirmation and adjudication before notifying the patient.
Study Visit 2 (Sv2):
The second study visit will take place in the form of a telephone call. After Sv1 a member of the research team will call participants to confirm eligibility and continued interest in the randomized controlled trial. If participants are still interested and eligible, they will continue with Sv3.
Study Visit 3 (Sv3):
The final study visit and randomization will take place at the LUNA field site, where the B-mode ultrasound machine will be stationed. During this time participants will have 1) the Carotid Intimal Medial Thickness (CIMT), the primary outcome, measured using non-invasive ultrasonography, 2) the difference in blood pressure between legs and arms, called Ankle Brachial Index (ABI), and 3) complete any outstanding/incomplete questionnaires from Sv1. During SV-3 the informed consent will be reviewed one more time. The physical measures of CIMT and ABI will be performed by trained technicians.
Also during Sv3, participants will be provided with Medication Event Monitoring System (MEMS) tracking caps. These caps will be used to objectively monitor participant adherence to their recommended chronic disease medications, either their lipid lowering, hypertensive or diabetes medication. In both groups it will provide the study with objective information on medication use behavior and for the intervention group the information serve as feedback to improve adherence to pill taking behavior.
Both control and experimental conditions will be asked to participate in the medication adherence study component, which will begin immediately after study group randomization. Participants' medication adherence will be monitored for one year including four prescription refill time points.
In addition to completing the comprehensive baseline assessments during SV-1 through SV-3, the extended screening period allows the participant time to consider and discuss their participation in the study. If participants have less than one defined CVD risk factors or refuse to participate in the RCT, they will be offered participation in the observational study (i.e. study in which only base-line measures and subsequent routine measures obtained during usual care will be analyzed). The observational group will serve as another comparison group for the overall chronic disease study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Special Intervention | Experimental | Behavioral: Special InterventionThe 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 intervention | –Usual 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. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- are pregnant (temporary exclusion-may qualify six months post partum)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Special InterventionParticipants 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. | Behavioural | Special Intervention |
Primary outcome
Change in Carotid Intimal Medial Thickness (CIMT) Measurement
Time frame: Baseline and 24-months
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.
1 secondary outcome
Medication Adherence
Time frame: Baseline and every 6-months for a maximum of 2-years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Talavera, MD/MPH principal investigator
San Diego State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Special Intervention in people with Atherosclerosis and High Blood Pressure, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Carotid Intimal Medial Thickness (CIMT) Measurement (time frame: Baseline and 24-months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2016; AzTrials last refreshed its copy on 31 Oct 2026.