NCT04035395

Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Diabetics in the Rio Grande Valley

Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Individuals With Diabetes in the Rio Grande Valley

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to implement a system of integrated health care that provides a continuum of care for those with diabetes. This study will use a randomized behavioral intervention trial experimental design to compare participants receiving the enhanced delivery of integrated behavioral care with nonparticipants receiving the usual care until after the study period, at which time they will be offered access to expansion services.

Detailed description

The Rio Grande Valley (RGV), located on the northern bank of the Rio Grande River that separates the United States from Mexico, is home to more than 1.2 million residents, representing about 5% of Texas' general population. The SyV 2.0 program focuses on the system of health care in the lower RGV, comprised of a predominantly Mexican American, low-income, underserved community with chronic disease rates and related mortality that exceed those in most other regions of the state and the nation. Based on a cohort study of 2,000 Mexican American adults from this region between 2003 to 2008 called the Cameron County Hispanic Cohort (CCHC), researchers estimated diabetes prevalence to be 31% and 81% of the population were either obese (49%) or overweight (32%). Residents in this region suffer from disproportionate health disparities that stem from extreme poverty (40% of families live below federal poverty line), lower levels of educational attainment (9.9 average years of education), and inadequate access to basic health care needs, income, and education. The SyV 2.0 program is an expansion of SyV 1.0, a program for individuals with uncontrolled diabetes. Enhancement includes two major initiatives: clinical-based services and community-based services. Clinical based services will include medication therapy management for participants with low levels of medication adherence and care coordination which includes behavioral health services for participants who do not qualify for services with the mental health authority, but need behavioral health support. Community-based services will include peer led support groups and access to community-based lifestyle programs (capacity building cooking classes and an obesity awareness program). Clinical-based and community-based services will be directed by a multidisciplinary care team and will be customized to meet each participant's individualized needs. The proposed study does not pose any major risks or dangers beyond what a normal physician visit would present. Benefits include improved control of chronic disease (diabetes, hypertension, and obesity), a reduction in depression, increased access to behavioral healthcare services, and improved adult functioning and quality of life for current SyV 1.0 participants. This study will contribute to the investigator's understanding of how to increase access to health care services and treatment among those individuals with diabetes, namely, low-income, Hispanic communities. * This study was not funded by the National Institutes of Health (NIH). It was funded by two Texas foundations, Methodist Healthcare Ministries and Valley Baptist Legacy Foundation.

Conditions

• Diabetes Mellitus, Type 2
• Behavior, Health

Interventions

Type	Name	Description
OTHER	Peer-led Support Group	The Viviendo Saludable pláticas (or talks) connected Salud y Vida participants living with diabetes together. These talks served as a forum for Salud y Vida participants to share their knowledge and experiences, including some that many health workers, friends, or family do not have. Viviendo Saludable helped participants develop better strategies for managing their diabetes in their daily life. The Viviendo Saludable pláticas complement and enhance the other services by helping participants create a network of emotional, social, and practical support needed to manage diabetes and stay healthy over the long term. Classes met once a week for one hour at locations central to participants' homes.
OTHER	Behavioral Health Consult	In a Behavioral Health consult, a participant meets with a counselor for one or more thorough meetings to talk about things that influence their health and well-being. A participant receiving a Behavioral Health consult receives support and is empowered with health coping skills that will allow for improved medication adherence and motivation to control their diabetes.
OTHER	Medication Therapy Management Consult	Medication Therapy Management helps participants and their doctors make sure that their medications are working to improve their health. In a Medication Therapy Management (MTM) consult, a pharmacist gives participants a comprehensive review of all their medications and speaks with them about 1) how well their medications are working, 2) whether their medications have side effects, 3) if there might be interactions between the drugs their taking, 4) whether costs can be lowered and 5) other problems participants are having. The participant will get a written summary of this discussion, including an action plan that recommends what can be done to make the best use of their medications.
OTHER	La Cocina Alegre/ The Happy Kitchen	The Happy Kitchen is a program where people come together to learn skills and self-sufficiency in preparing healthy, economical meals, laugh, cook, and enjoy food together. The cooking and nutrition program is an interactive 6-week series of classes, where the essential skills for healthy eating is taught and emphasis is placed on the selection and preparation of fresh, seasonal foods that are nutritious, economical, and delicious. Classes meet once a week for 1 ½ hours to cook, discuss, and learn together. All participants leave each class with recipes and groceries to practice new cooking skills.
OTHER	Mind, Exercise, Nutrition, Do it!	MEND is a diet and exercise education program that helps families support their kids, ages 6-13, to reach a healthy weight. The program teaches adults and their children how to maintain energy and confidence throughout the day while learning how to cook healthy meals. Each program lasts 10 weeks and classes are 2 times per week. An adult must attend with the child.

Timeline

• Start date: 2016-09-29
• Primary completion: 2018-06-13
• Completion: 2018-06-13
• First posted: 2019-07-29
• Last updated: 2019-08-02