E-Health Intervention for Type 2 Diabetes (LUNA-E Trial)
Palo Alto (17 mi)Overseen byGregory A Talavera, MD/MPH
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: N/A
Recruiting
Sponsor: San Diego State University
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial uses a team-based healthcare approach with online tools to help Latino patients with type 2 diabetes manage their condition. The goal is to improve blood sugar control and reduce stress and anxiety related to diabetes.
What safety data exists for the E-Health Intervention for Type 2 Diabetes?The research does not provide specific safety data for the E-Health Intervention for Type 2 Diabetes. However, it highlights the feasibility and effectiveness of tailored diabetes self-management educational interventions, particularly for Latinos. These interventions, which include the use of health information technology tools, patient navigators, and community health workers, have been shown to improve diabetes knowledge, self-management behaviors, and clinical outcomes. The studies emphasize the importance of culturally tailored interventions and the integration of digital health navigators to support patient engagement and adherence.237910
Is LUNA Behavioral Health, LUNA Care Coordination a promising treatment for Type 2 Diabetes?Yes, LUNA Behavioral Health, LUNA Care Coordination is a promising treatment for Type 2 Diabetes, especially for Latinos. It uses e-health technology to improve diabetes management by providing tailored support and education. This approach helps patients better manage their condition by offering frequent communication, personalized feedback, and involving community health workers. These strategies have been shown to improve health outcomes and make it easier for patients to stick to their treatment plans.23456
What data supports the idea that E-Health Intervention for Type 2 Diabetes is an effective treatment?The available research shows that E-Health Intervention for Type 2 Diabetes is effective, especially for Latino populations. Studies highlight that using technology and community health workers can improve diabetes management by increasing patient engagement and satisfaction. Tailored interventions that consider cultural and language needs have been successful in improving health outcomes like blood sugar levels. Compared to usual care, these interventions often lead to better results in managing diabetes.12389
Do I need to stop my current medications for this trial?The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators or your primary care provider for guidance.
Eligibility Criteria
This trial is for Hispanic/Latino adults with Type 2 diabetes and poor blood sugar control (HbA1c >8%). Participants must be registered at a qualifying health center, not in other diabetes programs, and have their doctor's approval. Exclusions include severe diabetes complications, current cancer or Parkinson's treatment, plans to move soon, severe health issues preventing consent, or being pregnant/nursing.Inclusion Criteria
My last HbA1c level was over 8%.
I am 18 years old or older.
Exclusion Criteria
I am currently receiving treatment for cancer or Parkinson's Disease.
I have severe diabetes complications like kidney problems or need dialysis.
Treatment Details
The LUNA-E study is testing a patient-centered care approach using virtual visits, coordinated care management, integrated medical and behavioral support alongside educational videos. This randomized trial aims to improve blood sugar levels and reduce psychological distress among participants.
2Treatment groups
Experimental Treatment
Active Control
Group I: LUNA GroupExperimental Treatment4 Interventions
The LUNA Group is a culturally appropriate, E-Health enhanced, patient-centered, team-care model that includes: 1) care coordination by a Care Coordinator (CC) trained in electronic health records (EHR) clinical decision support and health promotion methods; 2) visits with a specially trained Behavioral Health Provider (BHP) with knowledge of diabetes and psychosocial aspects of diabetes; 3) care integration with primary care provider (PCP) implemented using the clinical decision support dashboard and/or synchronous communication during visits; and 4) a video adapted, evidence-based diabetes self-management education and support curriculum delivered through a learning management system.
Group II: Care CoordinationActive Control1 Intervention
The Care Coordination group applies the current methods of the federally qualified health center (FHQC) Patient Centered Medical Home initiative. Participants assigned to the care coordination group will continue with their regular medical visits with their primary care provider. In addition, they will receive care coordination and brief targeted health education provided by a specially trained medical assistant/care coordinator. This will involve 1 or more brief sessions with a care coordinator to provide health education, assist with appointments and referrals, and review medications. The care coordinator will work closely with their primary care provider. The care coordinator will also assist with referrals to behavioral health that may be initiated by the primary care provider.
Find a clinic near you
Research locations nearbySelect from list below to view details:
South Bay Latino Research CenterChula Vista, CA
Loading ...
Who is running the clinical trial?
San Diego State UniversityLead Sponsor
References
Integrating education, group support, and case management for diabetic Hispanics. [2021]Culturally tailored diabetes self-management education (DSME) improves glycemic control and other health outcomes in Mexican Americans but sociocultural barriers to health improvements remain. This study explored the feasibility of adding a nurse case manager (NCM) to DSME to foster DSME attendance and increase utilization of other available health care services.
Closing the gap: eliminating health care disparities among Latinos with diabetes using health information technology tools and patient navigators. [2022]Latinos have higher rates of diabetes and diabetes-related complications compared to non-Latinos. Clinical diabetes self-management tools that rely on innovative health information technology (HIT) may not be widely used by Latinos, particularly those that have low literacy or numeracy, low income, and/or limited English proficiency. Prior work has shown that tailored diabetes self-management educational interventions are feasible and effective in improving diabetes knowledge and physiological measures among Latinos, especially those interventions that utilize tailored coaching and navigator programs. In this article, we discuss the role of HIT for diabetes management in Latinos and describe a novel "eNavigator" role that we are developing to increase HIT adoption and thereby reduce health care disparities.
Eliminating disparities among Latinos with type 2 diabetes: Effective eHealth strategies. [2021]Latinos are at increased risk for obesity and type 2 diabetes (T2D). Well-designed information technology (IT) interventions have been shown to be generally efficacious in improving diabetes self-management. However, there are very few published IT intervention studies focused on Latinos. With the documented close of the digital divide, Latinos stand to benefit from such advances. There are limited studies on how best to address the unique socio-cultural-linguistic characteristics that would optimize adoption, use and benefit among Latinos. Successful e-health programs involve frequent communication, bidirectionality including feedback, and multimodal delivery of the intervention. The use of community health workers (CHWs) has been shown consistently to improve T2D outcomes in Latinos. Incorporating CHWs into eHealth interventions is likely to address barriers with technology literacy and improve patient activation, satisfaction and adherence. Additionally, tailored interventions are more successful in improving patient activation. It is important to note that tailoring is more than linguistic translation; tailoring interventions to the Latino population will need to address educational, language, literacy and acculturation levels, along with unique illness beliefs and attitudes about T2D found among Latinos. Interventions will need to go beyond the lone participant and include shared decision making models that incorporate family members and friends.
Social Support for Diabetes Self-Management via eHealth Interventions. [2022]eHealth interventions have been increasingly used to provide social support for self-management of type 2 diabetes. In this review, we discuss social support interventions, types of support provided, sources or providers of support, outcomes of the support interventions (clinical, behavioral, psychosocial), and logistical and clinical considerations for support interventions using eHealth technologies. Many types of eHealth interventions demonstrated improvements in self-management behaviors, psychosocial outcomes, and clinical measures, particularly HbA1c. Important factors to consider in clinical application of eHealth support interventions include participant preferences, usability of eHealth technology, and availability of personnel to orient or assist participants. Overall, eHealth is a promising adjunct to clinical care as it addresses the need for ongoing support in chronic disease management.
Innovative Diabetes Interventions in the U.S. Hispanic Population. [2022]IN BRIEF In the United States, Hispanics have a 66% greater risk of developing type 2 diabetes and, once diagnosed, exhibit worse outcomes than non-Hispanic whites. It is therefore imperative to ensure that interventions meet the specific needs of this at-risk group. This article provides a selective review of the evidence on innovative, real-world approaches (both live and technology-based) to improving behavioral, psychosocial, and clinical outcomes in underserved Hispanics with type 2 diabetes. Key aspects of successful live interventions have included multimodal delivery, greater dosage/attendance, and at least some in-person delivery; effective technology-based approaches involved frequent but intermittent communication, bi-directional messaging, tailored feedback, multimodal delivery, and some human interaction. Across modalities, cultural tailoring also improved outcomes. Additional research is needed to address methodological limitations of studies to date and pinpoint the most efficacious components and optimal duration of interventions. Future efforts should also attend to variability within the U.S. Hispanic population to ensure acceptability and sustainability of interventions in this diverse group.
e-Health Interventions for Community-Dwelling Type 2 Diabetes: A Scoping Review. [2021]Background: Because type 2 diabetes mellitus is a critical health problem with increasing incidence, prevalence, and complications worldwide, e-health has been widely utilized for management in type 2 diabetes. Introduction: This scoping review of meta-analyses and systematic reviews on e-health interventions aimed to examine service platforms, program types, outcomes, current status of research activities, research gaps, and the effectiveness of type 2 diabetes self-care management among community-dwelling adults. Materials and Methods: Arksey and O'Malley's method was adopted for this review. The Ovid MEDLINE and Ovid EMBASE databases were searched from inception until April 2018. Two reviewers independently screened, selected, and charted studies using a piloted charting form. Discrepancies were resolved by consensus, and results were collated, summarized, and thematically analyzed. Results: The final studies (N = 81) related to e-health interventions included systematic reviews/meta-analyses on clinical effectiveness (n = 64), usability (n = 14), and behavioral outcomes (n = 47). The commonest e-health intervention subtypes for type 2 diabetes care were patient monitoring (53/163, 32.5%), treatment adherence (50/163, 30.7%), and diabetes-related advice/education (34/163, 20.9%). Mobile devices were most often used to provide e-health services (57/142, 40.1%), followed by the internet (41/142, 28.9%). The e-health strategy that was effective in controlling blood glucose in type 2 diabetes patients was a multimodal intervention comprising treatment advice or education, treatment adherence or reminder methods, and patient monitoring. Treatment adherence or reminder methods and/or patient monitoring showed behavioral effects, but the usability of e-health interventions was controversial. Conclusions: We suggest that e-health intervention should be complex intervention including treatment advice/education, patient monitoring, and treatment adherence or reminder methods.
Exchanges in a Virtual Environment for Diabetes Self-Management Education and Support: Social Network Analysis. [2021]Diabetes remains a major health problem in the United States, affecting an estimated 10.5% of the population. Diabetes self-management interventions improve diabetes knowledge, self-management behaviors, and clinical outcomes. Widespread internet connectivity facilitates the use of eHealth interventions, which positively impacts knowledge, social support, and clinical and behavioral outcomes. In particular, diabetes interventions based on virtual environments have the potential to improve diabetes self-efficacy and support, while being highly feasible and usable. However, little is known about the patterns of social interactions and support taking place within type 2 diabetes-specific virtual communities.
A Chronic Care Management Framework Bridging Clinic, Home, and Community Care in a Mexican American Population. [2022]Despite evidence that chronic care management improves outcomes, a framework designed for low income, uninsured populations is still needed to improve health disparities and guide further replication. We describe the Innovative Care for Chronic Conditions framework implemented by a coalition of clinics and agencies to address chronic care management for Mexican Americans with Type 2 diabetes mellitus who have low income and primarily uninsured. The core elements of the framework are described by clinic, home and community settings with community health workers playing an essential role in the delivery of community-based services that address the social determinants of health. Promising results are described. This framework expands the understanding of chronic care management approaches and contributes to further replication of the framework in diverse settings.
Latinos understanding the need for adherence in diabetes (LUNA-D): a randomized controlled trial of an integrated team-based care intervention among Latinos with diabetes. [2022]We developed and tested a culturally appropriate, team-based, integrated primary care and behavioral health intervention in low income, Spanish-speaking Latinos with type 2 diabetes, at a federally qualified health center. This pragmatic randomized controlled trial included 456 Latino adults, 23-80 years, 63.7% female, with diabetes [recruitment glycosylated hemoglobin (HbA1c) ≥ 7.0%/53.01 mmol/mol)]. The Special Intervention occurred over 6 months and targeted improvement of HbA1c, blood pressure, and lipids. The intervention included: (i) four, same-day integrated medical and behavioral co-located visits; (ii) six group diabetes self-management education sessions addressing the cultural dimensions of diabetes and lifestyle messages; (iii) and care coordination. Usual Care participants received primary care provider led standard diabetes care, with referrals to health education and behavioral health as needed. HbA1c and lipids were obtained through electronic health records abstraction. Blood pressure was measured by trained research staff. Multi-level models showed a significant group by time interaction effect (B = -0.32, p
Digital healthcare equity in primary care: implementing an integrated digital health navigator. [2023]The 21st Century Cures Act and the rise of telemedicine led to renewed focus on patient portals. However, portal use disparities persist and are in part driven by limited digital literacy. To address digital disparities in primary care, we implemented an integrated digital health navigator program supporting portal use among patients with type II diabetes. During our pilot, we were able to enroll 121 (30.9%) patients onto the portal. Of newly enrolled or trained patients, 75 (62.0%) were Black, 13 (10.7%) were White, 23 (19.0%) were Hispanic/Latinx, 4 (3.3%) were Asian, 3 (2.5%) were of another race or ethnicity, and 3 (2.5%) had missing data. Our overall portal enrollment for clinic patients with type II diabetes increased for Hispanic/Latinx patients from 30% to 42% and Black patients from 49% to 61%. We used the Consolidated Framework for Implementation Research to understand key implementation components. Using our approach, other clinics can implement an integrated digital health navigator to support patient portal use.