Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Individuals With Diabetes in the Rio Grande Valley
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 353
- 主要终点
- Rate of Change in Hemoglobin A1c
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
盲法说明
Participants were not told whether they had been randomized into the intervention or control group. However, when the participant was offered new intervention services, the participant could infer that they were part of the intervention group. Conversely, if a participant was only offered the standard intervention services, they could infer they were part of the control group.
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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%)
排除标准
- •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
研究组 & 干预措施
Intervention
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.
干预措施: Peer-led Support Group (Other)
Intervention
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.
干预措施: Behavioral Health Consult (Other)
Intervention
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.
干预措施: Medication Therapy Management Consult (Other)
Intervention
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.
干预措施: La Cocina Alegre/ The Happy Kitchen (Other)
Intervention
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.
干预措施: Mind, Exercise, Nutrition, Do it! (Other)
Control
Participants randomized to the usual care group will receive the SyV 1.0 program which includes community based program referrals (excluding intervention programs) and home-based visits from CHWs. These participants will also receive the standard follow-up from UTHealth staff such as a phone call, an information session as per their treatment plan, and /or a onetime mailing of information about the importance of following their treatment plan. Before implementation begins, additional details about standard care will be ascertained from partner organizations to better understand how these differ from the treatment conditions of the intervention group. Once the participant completes 12 months in the study, 2.0 services will be initiated.
结局指标
主要结局
Rate of Change in Hemoglobin A1c
时间窗: 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).
次要结局
- Rate of Change in Blood Pressure(12 month period)
- Rate of Change in BMI(12 month period)
- Rate of Change in Depressive Symptoms(12 month period)
- Rate of Change in Quality of Life: Duke Health Profile(12 month period)
- Rate of Change in Self-efficacy: Diabetes Self-Efficacy Scale(12 month period)
- Rate of Change in Total Cholesterol(12 month period)
研究者
Belinda Reininger
Professor and Regional Dean
The University of Texas Health Science Center, Houston