Clinical trial NCT04035395: Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Diabetics in the Rio Grande Valley
Official title: Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Individuals With Diabetes in the Rio Grande Valley
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Behavior, Health
Keywords: Integrated Behavioral Health
Community Health Workers
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Health Resources in Action, Inc.
First posted: 2019-07-29
Enrollment: 353
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Participants of the Salud y Vida (SyV) program who are patients at two specific clinics
* Reside in the lower Rio Grande Valley of Texas
* A diagnosis of poorly controlled diabetes (HbA1c greater than or equal to 9.0%)
* Enrollment in the SyV 1.0 services for a minimum of 6 months
* At 6 months still have uncontrolled diabetes (HbA1c greater than or equal to 9.0%)

Exclusion Criteria:

* Enrollment in another research study
* Does not speak either English or Spanish
* Immediate family member of current SyV 2.0 participant
* Not a registered patient at 1 of the 2 specified clinics

Primary outcomes:
measure: Rate of Change in Hemoglobin A1c
timeFrame: 12 month period
Secondary outcomes:
measure: Rate of Change in Blood Pressure
timeFrame: 12 month period
measure: Rate of Change in BMI
timeFrame: 12 month period
measure: Rate of Change in Depressive Symptoms
timeFrame: 12 month period
measure: Rate of Change in Quality of Life: Duke Health Profile
timeFrame: 12 month period
measure: Rate of Change in Total Cholesterol
timeFrame: 12 month period
measure: Rate of Change in Self-efficacy: Diabetes Self-Efficacy Scale
timeFrame: 12 month period
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Belinda M. Reininger, DrPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fisher-Hoch SP, Vatcheva KP, Laing ST, Hossain MM, Rahbar MH, Hanis CL, Brown HS 3rd, Rentfro AR, Reininger BM, McCormick JB. Missed opportunities for diagnosis and treatment of diabetes, hypertension, and hypercholesterolemia in a Mexican American population, Cameron County Hispanic Cohort, 2003-2008. Prev Chronic Dis. 2012;9:110298. doi: 10.5888/pcd9.110298.
citation: Reininger BM, Lee M, Hessabi M, Mitchell-Bennett LA, Sifuentes MR, Guerra JA, Ayala CD, Xu T, Polletta V, Flynn A, Rahbar MH. Improved diabetes control among low-income Mexican Americans through community-clinical interventions: results of an RCT. BMJ Open Diabetes Res Care. 2020 May;8(1):e000867. doi: 10.1136/bmjdrc-2019-000867.