Salud y Vida 2.0: Enhancing Integrated Behavioral Health for Diabetics in the Rio Grande Valley
1 other identifier
interventional
353
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes-mellitus-type-2
Started Sep 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 13, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2018
CompletedFirst Submitted
Initial submission to the registry
July 24, 2019
CompletedFirst Posted
Study publicly available on registry
July 29, 2019
CompletedAugust 2, 2019
July 1, 2019
1.7 years
July 24, 2019
July 30, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Rate of Change in Hemoglobin A1c
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).
12 month period
Secondary Outcomes (6)
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 Total Cholesterol
12 month period
- +1 more secondary outcomes
Study Arms (2)
Intervention
EXPERIMENTALParticipants 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.
Control
NO INTERVENTIONParticipants 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.
Interventions
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.
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 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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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%)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
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.
PMID: 22863308BACKGROUNDReininger 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.
PMID: 32475836DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Belinda M. Reininger, DrPH
The University of Texas Health Science Center, Houston
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- 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.
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor and Regional Dean
Study Record Dates
First Submitted
July 24, 2019
First Posted
July 29, 2019
Study Start
September 29, 2016
Primary Completion
June 13, 2018
Study Completion
June 13, 2018
Last Updated
August 2, 2019
Record last verified: 2019-07
Data Sharing
- IPD Sharing
- Will not share