Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Diabetics in the Rio Grande Valley
- Conditions
- Behavior, HealthDiabetes Mellitus, Type 2
- Interventions
- Other: Peer-led Support GroupOther: Behavioral Health ConsultOther: Medication Therapy Management ConsultOther: La Cocina Alegre/ The Happy KitchenOther: Mind, Exercise, Nutrition, Do it!
- Registration Number
- NCT04035395
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 353
- 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%)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Peer-led Support Group Participants randomized to the intervention group will receive the SyV 2.0 program, which in addition to standard diabetes management services of SyV 1.0 services, could include MTM services, care coordination by a team of behavioral health care providers, and/or referrals to community-based lifestyle programs, as determined by their tailored care plan. The participant will be seen by evaluation staff to complete baseline assessment for the study. Then, an individualized care plan will be developed by SyV 1.0 interdisciplinary staff and reviewed by the chronic care case management team. The care plan will include information on additional services provided by UTHealth such as, but not limited to, behavioral health services, or pharmacy services. Each participant will receive an individualized care plan and when applicable, referrals to community-based programs. Evaluation staff and CHWs will make follow-up appointments for the participant depending on their care plan. Intervention Behavioral Health Consult Participants randomized to the intervention group will receive the SyV 2.0 program, which in addition to standard diabetes management services of SyV 1.0 services, could include MTM services, care coordination by a team of behavioral health care providers, and/or referrals to community-based lifestyle programs, as determined by their tailored care plan. The participant will be seen by evaluation staff to complete baseline assessment for the study. Then, an individualized care plan will be developed by SyV 1.0 interdisciplinary staff and reviewed by the chronic care case management team. The care plan will include information on additional services provided by UTHealth such as, but not limited to, behavioral health services, or pharmacy services. Each participant will receive an individualized care plan and when applicable, referrals to community-based programs. Evaluation staff and CHWs will make follow-up appointments for the participant depending on their care plan. Intervention Medication Therapy Management Consult Participants randomized to the intervention group will receive the SyV 2.0 program, which in addition to standard diabetes management services of SyV 1.0 services, could include MTM services, care coordination by a team of behavioral health care providers, and/or referrals to community-based lifestyle programs, as determined by their tailored care plan. The participant will be seen by evaluation staff to complete baseline assessment for the study. Then, an individualized care plan will be developed by SyV 1.0 interdisciplinary staff and reviewed by the chronic care case management team. The care plan will include information on additional services provided by UTHealth such as, but not limited to, behavioral health services, or pharmacy services. Each participant will receive an individualized care plan and when applicable, referrals to community-based programs. Evaluation staff and CHWs will make follow-up appointments for the participant depending on their care plan. Intervention La Cocina Alegre/ The Happy Kitchen Participants randomized to the intervention group will receive the SyV 2.0 program, which in addition to standard diabetes management services of SyV 1.0 services, could include MTM services, care coordination by a team of behavioral health care providers, and/or referrals to community-based lifestyle programs, as determined by their tailored care plan. The participant will be seen by evaluation staff to complete baseline assessment for the study. Then, an individualized care plan will be developed by SyV 1.0 interdisciplinary staff and reviewed by the chronic care case management team. The care plan will include information on additional services provided by UTHealth such as, but not limited to, behavioral health services, or pharmacy services. Each participant will receive an individualized care plan and when applicable, referrals to community-based programs. Evaluation staff and CHWs will make follow-up appointments for the participant depending on their care plan. Intervention Mind, Exercise, Nutrition, Do it! Participants randomized to the intervention group will receive the SyV 2.0 program, which in addition to standard diabetes management services of SyV 1.0 services, could include MTM services, care coordination by a team of behavioral health care providers, and/or referrals to community-based lifestyle programs, as determined by their tailored care plan. The participant will be seen by evaluation staff to complete baseline assessment for the study. Then, an individualized care plan will be developed by SyV 1.0 interdisciplinary staff and reviewed by the chronic care case management team. The care plan will include information on additional services provided by UTHealth such as, but not limited to, behavioral health services, or pharmacy services. Each participant will receive an individualized care plan and when applicable, referrals to community-based programs. Evaluation staff and CHWs will make follow-up appointments for the participant depending on their care plan.
- Primary Outcome Measures
Name Time Method Rate of Change in Hemoglobin A1c 12 month period Participants who receive SyV 2.0 will experience a change in HbA1c after 12 months compared to participants who receive SyV 1.0 (the standard of care).
- Secondary Outcome Measures
Name Time Method Rate of Change in Blood Pressure 12 month period Participants who receive SyV 2.0 will experience a change in their blood pressure after 12 months compared to participants who receive SyV 1.0. Both systolic and diastolic pressures will be assessed during the study period.
Rate of Change in BMI 12 month period Participants who receive SyV 2.0 will experience a change in their BMI after 12 months compared to overweight or obese participants who receive SyV 1.0.
Rate of Change in Depressive Symptoms 12 month period Participants who receive SyV 2.0 will experience a change in their depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9), after 12 months compared to participants who receive SyV 1.0. The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The PHQ-9 total possible score is 27. The PHQ-9 scoring criteria is categorized as minimal (0-4), mild (5-9), moderate (10-14), moderately severe (15-19) and severe (20-27) depression. Higher values represent worse outcome.
Rate of Change in Quality of Life: Duke Health Profile 12 month period Participants who receive SyV 2.0 will experience a change in their quality of life, as measured by the Duke Health Profile, after 12 months compared to participants who receive SyV 1.0. The Duke Health Profile is a 17-item generic questionnaire instrument designed to measure adult self-reported functional health status quantitatively during a one-week time window. The Duke Health profile has 11 scales, six of which measure function and five of which measure dysfunction. Scores range from 0 to 100. For scales measuring function, the higher the score, the more functional the person being evaluated. For scales measuring dysfunction, the higher the score, the more dysfunctional the person being evaluated. The general health domain score, a composite of the physical health, mental health and social health domain scores, was utilized as the primary quality of life indicator in our analyses.
Rate of Change in Self-efficacy: Diabetes Self-Efficacy Scale 12 month period Participants who receive SyV 2.0 will experience a change in self-efficacy, as measured by the Diabetes Self-Efficacy Scale, after 12 months compared to participants who receive SyV 1.0. The Diabetes Self-Efficacy Scale is an 8-item generic questionnaire instrument that is self-reported and designed to measure adult patient perception in regard to performing self-care tasks related to diabetes. The Diabetes Self-Efficacy Scale has 8 items. Scores range from 0 to 10. The lower the score, the lower the self-efficacy of the person being evaluated.
Rate of Change in Total Cholesterol 12 month period Participants who receive SyV 2.0 will experience a change in their total cholesterol after 12 months compared to participants who receive SyV 1.0.