Latinos Understanding the Need for Adherence — LUNA  

Type 2 Diabetes Mellitus Clinical Trial

Official title: San Diego Partnership to Reduce Diabetes & Cardiovascular Disease in Latinos

Status Completed

Clinical 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 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.

Clinical Trial 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atherosclerosis
• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Heart Disease
• Heart Diseases
• High Blood Pressure
• Hypercholesterolemia
• Hypertension
• Type 2 Diabetes Mellitus

• NCT number: NCT02955238
• Study type: Interventional
• Source: San Diego State University
• Status: Completed
• Phase: N/A
• Start date: August 2009
• Completion date: October 2013