Trial Summary
What is the purpose of this trial?
The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with a larger number of adult Haitian immigrants.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Diabetes Self-Management Education (DSME) and Support (DSMS) for managing Type 2 Diabetes?
Research shows that integrating Diabetes Self-Management Education and Support (DSMES) into primary care significantly improves blood sugar control and body mass index (BMI) in patients with Type 2 Diabetes. This approach helps patients better manage their condition and can lead to improved health outcomes.12345
Is Diabetes Self-Management Education and Support (DSMES) safe for humans?
How is the Diabetes Self-Management treatment unique for managing Type 2 Diabetes?
The Diabetes Self-Management treatment is unique because it focuses on empowering patients through education and support, using the ADCES7 Self-Care Behaviors framework to improve self-management and quality of life. This approach emphasizes behavior change and collaboration with healthcare teams, rather than relying solely on medication.14589
Research Team
CM
Cherlie Magny-Normilus, PhD, FNP-BC
Principal Investigator
Boston College
Eligibility Criteria
This trial is for adult Haitian immigrants, aged 21 or older, who have been living in the US for at least a year and have had type 2 diabetes diagnosed for over a year with an HbA1c level of 7.5% or higher. Participants must be willing to engage in an interview. Those with type 1 diabetes or unable to fully participate are excluded.Inclusion Criteria
I am a Haitian immigrant and I am 21 years old or older.
Have lived in the US for at least one year
I have been diagnosed with type 2 diabetes for over a year.
See 2 more
Exclusion Criteria
I am able to understand and agree to participate in the study.
I have been diagnosed with type 1 diabetes.
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive either the culturally tailored Diabetes Self-Management Education Program or standard care. The program includes an initial 45-minute consultation and six 2-hour weekly educational sessions.
6 weeks
1 initial consultation, 6 weekly sessions
Follow-up
Participants are monitored for changes in diabetes distress, physical activity, glucose variability, self-management behaviors, and self-efficacy.
12 weeks
Treatment Details
Interventions
- Diabetes Self-Management Behaviors (Behavioral Intervention)
- Objective. data (Behavioral Intervention)
- Physical activity (Other)
Trial OverviewThe study is testing the effectiveness of a new education program designed to help participants manage their type 2 diabetes better on their own. It's a pilot randomized study which means some people will receive the program while others may not, by chance.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Diabetes Self-Management BehaviorsExperimental Treatment1 Intervention
Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks.
Group II: Usual Type 2 Diabetes CareActive Control1 Intervention
The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study.
Diabetes Self-Management Behaviors is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Diabetes Self-Management Education for:
- Type 2 Diabetes Management
- Glycemic Control
🇪🇺 Approved in European Union as Diabetes Self-Management Support for:
- Type 1 Diabetes Management
- Type 2 Diabetes Management
- Prediabetes Management
🇨🇦 Approved in Canada as ADCES7 Self-Care Behaviors for:
- Diabetes Management
- Cardiometabolic Disease Management
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston CollegeChestnut Hill, MA
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Who Is Running the Clinical Trial?
Boston College
Lead Sponsor
Trials
40
Patients Recruited
49,300+
National Institute of Nursing Research (NINR)
Collaborator
Trials
623
Patients Recruited
10,400,000+
National Institutes of Health (NIH)
Collaborator
Trials
2896
Patients Recruited
8,053,000+
References
An Effective Model of Diabetes Care and Education: The ADCES7 Self-Care Behaviors™. [2021]Label="PURPOSE">The ADCES7 Self-Care Behaviors™ (ADCES7) is a robust framework for self-management of diabetes and other related conditions, such as prediabetes and cardiometabolic diseases. It is the position of the Association of Diabetes Care and Education Specialists (ADCES) that at the cornerstone of diabetes self-management education and support, the ADCES7 is the framework for achieving behavior change that leads to effective self-management through improved behavior and clinical outcome measures. The ADCES7 model guides the health care team in effective person-centered collaboration and goal setting to achieve health-related outcomes and improved quality of life. Continued research and evidence are critical to expand this model and broaden its application to other chronic conditions. Given the advances in the science of diabetes management as well as diabetes self-management education and support, ADCES has evaluated the ADCES7 within the framework of these advances, including the digital and dynamic health care landscape.
Exploring the Clinical Outcomes of Implementing Diabetes Self-Management Education and Support in a Primary Care Practice: A Quality Improvement Project. [2023]Introduction/Purpose: Diabetes self-management education and support (DSMES) can be a very valuable service for many patients with diabetes. Unfortunately, despite its expected benefits, many patients do not receive DSMES through a quality, structured program. The purpose of this quality improvement project was to determine if integrating a diabetes education program utilizing the Association of Diabetes Care and Education Specialists (ADCES)7 Self-Care Behaviors into diabetes care in a primary care clinic could improve glycemic control and body mass index (BMI). Methods: The DSMES services provided were in accordance with the ADCES and the American Diabetes Association National Standards. The program included a 1-hour face-to-face service incorporating the ADCES7 Self-Care behaviors. A retrospective chart review was conducted to extract outcome data from N = 54 random medical records. This data was then analyzed to evaluate the program's effectiveness. Pre- and postintervention data from medical records were analyzed for eligible patients who participated in the DSMES service (ages 18-75 with type 2 diabetes, hemoglobin A1c [A1c] >8%). Results: Paired t tests were used to determine significant changes in BMI and A1c parameters pre- and postintervention. Preintervention A1c (M = 9.5, SD = 1.7) and BMI (M = 33.2, SD = 7.8) and postintervention A1c (M = 7.8, SD = 1.5) and BMI (M = 32.2, SD = 7.9) indicate that DSMES significantly reduced A1c, t(53) = 8.1, p = <.001, and BMI, t(53) = 4.4, p = <.001. Models were then adjusted for pretest measures, age, gender, and time since diagnosis in a regression analysis. In models adjusted for pretest measures, age, gender, and time since diagnosis was significantly predictive of the postmeasure of BMI (B = .41, p = .01, R2 = .96) and postmeasure of A1c (B = .28, p = .04, R2 =.41). Discussion: This project demonstrated that integrating a simple, cost-effective diabetes education service consisting of ADCES7 Self-Care Behaviors in a primary care practice could bridge gaps in diabetes management and significantly improve patients' BMI and A1c. Long-term utilization of this service may also enhance patient satisfaction, improve the patient's health, and reduce healthcare costs related to diabetes.
Insights From the National Diabetes Education Program National Diabetes Survey: Opportunities for Diabetes Self-Management Education and Support. [2020]IN BRIEF Diabetes self-management education and support (DSMES) provides the foundation to help people with diabetes (PWD) navigate the numerous self-management decisions and complex care activities they face daily and has been shown to improve outcomes. Without DSMES, PWD often lack the skills and knowledge necessary to handle the demands of managing this chronic disease. Understanding self-management behaviors and responses to DSMES is essential for improving DSMES processes and diabetes outcomes. This article provides the most recent findings from questions regarding self-management behaviors and DSMES practices obtained through the National Diabetes Education Program National Diabetes Survey. Insights and gaps in self-management behaviors and DSMES delivery are examined to identify challenges and offer opportunities for improvement.
An Effective Model of Diabetes Care and Education: Revising the AADE7 Self-Care Behaviors®. [2021]Label="PURPOSE">The AADE7 Self-Care Behaviors® (AADE7) is a robust framework for self-management of diabetes and other related conditions, such as prediabetes and cardiometabolic diseases. It is the position of the American Association of Diabetes Educators (AADE) that, at the cornerstone of diabetes self-management education and support, the AADE7 is the framework for achieving behavior change that leads to effective self-management through improved behavior and clinical outcome measures. The AADE7 model guides the health care team in effective person-centered collaboration and goal setting to achieve health-related outcomes and improved quality of life. Continued research and evidence are critical to expand this model and broaden its application to other chronic conditions. Given the advances in the science of diabetes management, as well as in diabetes self-management education and support, AADE has evaluated the AADE7 within the framework of these advances, including the digital and dynamic health care landscape.
Patients' and healthcare professionals' perspectives towards technology-assisted diabetes self-management education. A qualitative systematic review. [2020]Diabetes self-management education is a key aspect in the long-term management of type 2 diabetes. The patient and healthcare professional (HCP) perspective on the use of technology-assisted DSME has yet to be studied. Hence, the objective of this study was to better understand the factors that facilitate or hinder the adoptions of such education by adults with type 2 diabetes and their HCPs.
2017 National Standards for Diabetes Self-Management Education and Support. [2022]Purpose The purpose of this study is to review the literature for Diabetes Self-Management Education and Support (DSMES) to ensure the National Standards for DSMES (Standards) align with current evidence-based practices and utilization trends. Methods The 10 Standards were divided among 20 interdisciplinary workgroup members. Members searched the current research for diabetes education and support, behavioral health, clinical, health care environment, technical, reimbursement, and business practice for the strongest evidence that guided the Standards revision. Results Diabetes Self-Management Education and Support facilitates the knowledge, skills, and ability necessary for diabetes self-care as well as activities that assist a person in implementing and sustaining the behaviors needed to manage their condition on an ongoing basis. The evidence indicates that health care providers and people affected by diabetes are embracing technology, and this is having a positive impact of DSMES access, utilization, and outcomes. Conclusion Quality DSMES continues to be a critical element of care for all people with diabetes. The DSMES services must be individualized and guided by the concerns, preferences, and needs of the person affected by diabetes. Even with the abundance of evidence supporting the benefits of DSMES, it continues to be underutilized, but as with other health care services, technology is changing the way DSMES is delivered and utilized with positive outcomes.
Patient-specific factors associated with use of diabetes self-management education and support programs in Louisiana. [2022]The prevalence of diabetes self-management education and support (DSME/S) use among patients with newly diagnosed type 2 diabetes mellitus (T2DM) and patients with insulin prescription has not been evaluated. It is also unclear what demographic, behavioral, and clinical factors associated with use of DSME/S.
An Analysis of Diabetes Mobile Applications Features Compared to AADE7™: Addressing Self-Management Behaviors in People With Diabetes. [2019]Label="BACKGROUND">Diabetes self-management (DSM) applications (apps) have been designed to improve knowledge of diabetes and self-management behaviors. However, few studies have systematically examined if diabetes apps followed the American Association of Diabetes Educators (AADE) Self-Care Behaviors™ guidelines. The purpose of this study was to compare the features of current DSM apps to the AADE7™ guidelines.
Diabetes Self-management Education Provision by an Interprofessional Collaborative Practice Team: A Quality Improvement Project. [2019]Please note that citations/references numbers are not included in abstracts; please modify if needed: Diabetes is a major health problem and requires patients with diabetes to gain knowledge to manage their care effectively. The shift in diabetes care is to focus teaching on self-management to engage and empower patients with diabetes to live the best quality of life. Health care providers may not always be aware of diabetes self-management education available to patients. The American Association of Diabetes Educators has identified 7 essential self-care behaviors known as AADE7. The focus of this quality improvement project is to increase the provision and documentation of diabetes self-management education at a health center in Cincinnati, Ohio.