Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Diabetics in the Rio Grande Valley
NCT ID: NCT04035395
Last Updated: 2019-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
353 participants
INTERVENTIONAL
2016-09-29
2018-06-13
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
No interventions assigned to this group
Interventions
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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.
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.
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.
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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
74 Years
ALL
Yes
Sponsors
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Health Resources in Action, Inc.
OTHER
The University of Texas Health Science Center, Houston
OTHER
Responsible Party
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Belinda Reininger
Professor and Regional Dean
Principal Investigators
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Belinda M. Reininger, DrPH
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
References
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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.
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.
Related Links
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U.S. Census Bureau. (2013). 2013 American Community Survey 5-Year Estimates.
Other Identifiers
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HSC-SPH-16-0044
Identifier Type: -
Identifier Source: org_study_id
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