Educational Intervention for High Blood Sugar

Overseen By Neha V Maddali, BSPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Age < 18, Blood glucose < 200

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on increasing knowledge and awareness of Type 2 Diabetes among patients visiting the Emergency Department with high blood sugar levels. The researchers aim to determine if educational materials can help patients understand their risk and encourage healthier habits. Participants will receive educational packets about diabetes symptoms and risk factors, in addition to their regular emergency care. This trial suits anyone visiting the emergency room with a blood sugar level of 200 mg/dL or higher who can speak English. As an unphased study, it offers a unique opportunity to gain valuable insights into managing diabetes effectively.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. It seems to focus on educational intervention rather than medication changes.

What prior data suggests that this educational intervention is safe?

A previous study demonstrated that educational programs are safe and easy for people to handle. Research shows these programs can help individuals make lifestyle changes without harmful effects. For example, strong evidence indicates that diabetes self-management education and support (DSMES) can increase knowledge and improve health without causing side effects.

Educational programs emphasize teaching and guidance rather than medicine or medical procedures. This approach eliminates the risk of physical side effects, ensuring safety for participants. Overall, participating in a trial using educational materials poses no physical risk and can offer valuable knowledge for managing health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for high blood sugar, which typically involve medications like metformin and lifestyle changes such as diet and exercise, this educational intervention offers something different. Researchers are excited because it emphasizes empowering patients with knowledge about Type 2 Diabetes, its symptoms, and risk factors, alongside standard emergency care. This approach aims to enhance patient understanding and self-management, potentially leading to better long-term health outcomes. By focusing on education, the intervention could help patients make informed decisions about their health and encourage proactive follow-up care, which is a fresh angle in managing high blood sugar.

What evidence suggests that this educational intervention is effective for increasing diabetes knowledge and awareness?

Research has shown that learning about diabetes can help people manage the condition more effectively. In this trial, participants in the intervention arm will receive educational materials about Type 2 Diabetes Mellitus, covering symptoms, risk factors, and resources for further follow-up care. Studies indicate that education on self-care for people with type 2 diabetes increases their knowledge and improves their self-care practices. One study found that these educational programs can lead to better blood sugar control and healthier habits. Specifically, participants in that study demonstrated improvements in their blood sugar levels and gained a better understanding of their condition. This suggests that gaining knowledge about diabetes can help people make positive changes in their health. ^{1 6 7 8 9}

Who Is on the Research Team?

Sara Heinert, PhD, MPH

Principal Investigator

Rutgers Robert Wood Johnson Medical School

Are You a Good Fit for This Trial?

This trial is for English-speaking adults 18 or older who come to the Robert Wood Johnson University Hospital Emergency Department with high blood sugar levels (≥200 mg/dL), whether they've been diagnosed with Type 2 Diabetes Mellitus before or not.

Inclusion Criteria

I am 18 or older, might have Type 2 Diabetes, and my blood sugar is 200 mg/dL or higher.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Intervention

Participants receive educational materials on Type 2 Diabetes Mellitus and resources for follow-up care during their Emergency Department visit

1 day

1 visit (in-person)

Follow-up

Participants complete a post-survey to assess changes in diabetes knowledge and health behaviors

2 weeks

1 visit (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Educational Intervention

Trial Overview The study tests if an educational packet given during an emergency visit can boost patients' understanding of Type 2 Diabetes and encourage healthier lifestyle choices. Participants will be surveyed at their visit and two weeks later to measure the intervention's effectiveness.

How Is the Trial Designed?

Group I: Intervention Arm Experimental Treatment 1 Intervention

Participants in the intervention arm will receive Type 2 Diabetes Mellitus educational materials that includes information regarding Type 2 Diabetes symptoms, risk factors, and resources for further follow-up care alongside standard Emergency Medicine care, which includes discharge instructions provided by ED practitioners along with verbal explanations from their assigned ED nurse.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

A web-based eLearning module was developed to educate healthcare professionals on preventing hypoglycemia related to diabetes medications, based on formative research and stakeholder feedback.

After its release, the training received over 24,000 unique page views and more than 90% of participants felt confident in applying the knowledge gained, indicating its effectiveness in improving healthcare practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive Web-Based Learning: Translating Health Policy Into Improved Diabetes Care. Rider, BB., Lier, SC., Johnson, TK., et al.[2017]

Integrating web-based diabetes survival skills education (DSSE) into nursing workflows is seen as beneficial by healthcare staff, highlighting a strong interest in improving patient education for diabetes management during hospital discharge.

Key barriers to implementation include concerns about tablet usability, infection control, and workflow integration, indicating that adaptations are necessary to successfully deliver DSSE in inpatient settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Redesigning Hospital Diabetes Education: A Qualitative Evaluation With Nursing Teams. Smith, KM., Baker, KM., Bardsley, JK., et al.[2020]

Both diabetes education programs, 'the ABC's of Diabetes' and 'Conversation Maps', showed a trend towards improved glycemic control, with reductions in HbA1c levels of 0.2% and 0.6% respectively after 6 months, indicating their effectiveness in managing diabetes.

Patients with higher initial HbA1c levels (≥8%) experienced a significant drop of 1.1% in HbA1c three months after attending either class, suggesting that both educational formats can effectively support diabetes self-management, regardless of their intensity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A pragmatic comparison of two diabetes education programs in improving type 2 diabetes mellitus outcomes. Dorland, K., Liddy, C.[2022]

A systematic review of 13 studies on patient education for Type 2 diabetes found that multi-component educational interventions can lead to mixed results in diabetic control, with longer interventions showing more consistent positive effects.

Education delivered by a multi-professional team, along with reinforcement at additional contact points, appears to be the most effective approach for improving patient outcomes in diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of diabetes education models for Type 2 diabetes: a systematic review. Loveman, E., Frampton, GK., Clegg, AJ.[2022]

A 5-year interactive educational program for 148 elderly diabetic patients significantly improved their knowledge and skills in managing diabetes, leading to better treatment adherence and self-management.

Participants experienced notable health benefits, including reduced body weight, lower doses of antidiabetic medications, and improved HbA1c levels, along with fewer diabetes-related emergencies and hospital admissions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes education in the elderly: a 5-year follow-up of an interactive approach. García, R., Suárez, R.[2019]

In a study of 185 insulin-treated patients with type 2 diabetes, higher levels of communicative and critical health literacy were linked to better glycemic control, as measured by lower HbA1c levels after 9 months.

Patient empowerment significantly improved health literacy over time, which in turn directly contributed to better glycemic control, suggesting that empowering patients can enhance their ability to manage their diabetes effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling patient empowerment and health literacy to glycemic control in insulin-treated patients: A prospective study. Wang, RH., Hsu, HC., Chen, SY., et al.[2022]

Patient education programs can significantly enhance self-management of chronic illnesses like diabetes, which is crucial for prevention and lifestyle modification.

Evaluating the effectiveness of these programs is complex due to various influencing factors, including patient demographics, disease characteristics, and healthcare system dynamics, all of which must be considered in research design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measures and methods in evaluating patient education programs for chronic illness. Lane, DS., Evans, D.[2019]

Continuous education for diabetic patients is crucial, as it empowers them to make informed decisions and manage their condition effectively, leading to better long-term glycemic control.

Using practical and visual educational tools enhances learning and retention, which has been shown to improve glycemic control in both individual and group education settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effectiveness of education in diabetes care management - instructions for educators]. Jirkovská, J.[2018]

The activation intervention increased patient involvement in diabetes self-management discussions, which was linked to better glycemic control, indicating that engaging patients actively can enhance their management of the disease.

Despite the increased involvement, the activation intervention itself did not lead to a direct improvement in HbA1c levels, suggesting that while patient engagement is beneficial, it may not be sufficient alone to improve clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promoting glycemic control through diabetes self-management: evaluating a patient activation intervention. Williams, GC., McGregor, H., Zeldman, A., et al.[2022]

Diabetes education is crucial for effective self-care management, but there is significant inconsistency in how educational interventions are reported in the literature, making it hard to interpret research results.

The authors propose a new taxonomy to improve the design and reporting of diabetes educational interventions, which they applied to 30 randomized controlled trials to demonstrate the existing variation in these programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A taxonomy for diabetes educational interventions. Elasy, TA., Ellis, SE., Brown, A., et al.[2019]

A structured interactive group education program for 150 patients with type 2 diabetes led to significant reductions in HbA1c levels at 12 and 24 months, indicating improved blood sugar control.

Patients with a shorter duration of diabetes were more likely to benefit from the education program, suggesting that early intervention is crucial for maximizing the effectiveness of diabetes education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Targeting educational therapy for type 2 diabetes: identification of predictors of therapeutic success. da Vico, L., Monami, M., Biffi, B., et al.[2022]

In a study of 150 patients at a safety-net hospital, the initiation of SGLT2 inhibitors led to significant improvements in cardiovascular markers, including a reduction in systolic blood pressure by an average of 3.12 mm Hg, a decrease in urine microalbumin by 3.98 mg/dL, and a reduction in hemoglobin A1c by 1.06%.

Despite the positive outcomes, only 4% of patients had their renal function monitored within the recommended 14-day period, highlighting a need for better education and adherence to monitoring protocols among healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Sodium-glucose Cotransporter-2 Inhibitor Initiation in a Safety-net Hospital. Wienkers, S., Boka, A., Krantz, MJ.[2023]

The study developed a consensus list of 22 essential communication elements for safely managing patients with diabetes during transitions of care, addressing the high rates of serious hypoglycemic events associated with antihyperglycemic agents.

This Diabetes Management Discharge Communication List categorizes key information into three areas: diagnosis and treatment, factors affecting glycemic control, and patient self-management, aiming to enhance safety and quality of care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Defining Minimum Necessary Communication During Care Transitions for Patients on Antihyperglycemic Medication: Consensus of the Care Transitions Task Force of the IPRO Hypoglycemia Coalition. Munshi, MN., Sy, SL., Florez, HJ., et al.[2022]

The Next Education (NEED) patient education approach significantly improved self-management skills and medication adherence among 193 diabetes patients at intervention sites compared to 58 control patients.

The success of the NEED approach was linked to its participatory methods, which fostered better group dynamics and patient motivation, although similar positive mechanisms were also noted at control sites.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What does theory-driven evaluation add to the analysis of self-reported outcomes of diabetes education? A comparative realist evaluation of a participatory patient education approach. Pals, RA., Olesen, K., Willaing, I.[2022]

Citations

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Effect of educational intervention based on PRECEDE ... The present study aimed to evaluate the Effect of educational intervention based on PRECEDE model on lifestyle, self-management, and hypertension of diabetic ...

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Effectiveness of diabetes self-management education (DSME ... In conclusion, diabetes self-management education intervention has been shown to be effective in dealing with type 2 diabetes mellitus. Furthermore, DSME has a ...

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Mobile Health Intervention in Patients With Type 2 Diabetes A clinical pharmacist and health coach–delivered mobile health intervention can improve blood glucose levels in African American and Latinx populations.

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Comparative effectiveness of diabetes self-management ... Comparative effectiveness of diabetes self-management education and support intervention strategies among adults with type 2 diabetes in Texas. Marcia G. Ory, ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10433589/

The impact of patient navigation on glycemic control ... After the intervention, glycemic control improved in 37 (24.3%) participants (p < 0.001), and knowledge about diabetes also improved in 37 (24.3 ...

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Educational Model and Prevention on Prediabetes The current study reviews the roles of early detection, educational models, life modification, and prophylaxis of individuals with prediabetes

7. dmsjournal.biomedcentral.com dmsjournal.biomedcentral.com/articles/10.1186/s13098-023-01147-1

The impact of patient navigation on glycemic control ... This study aims to evaluate the effect of patient navigation on glycemic control, disease knowledge, adherence to self-care in people with type 1 diabetes ...

8. researchgate.net researchgate.net/publication/321196823_Patient_navigation_to_improve_diabetes_outpatient_care_at_a_safety-net_hospital_A_retrospective_cohort_study

(PDF) Patient navigation to improve diabetes outpatient ... The objective of this study was to evaluate the effect of a patient navigation program on medical and administrative outcomes among patients ...

9. diabetesjournals.org diabetesjournals.org/care/article/45/11/2753/147671/Management-of-Hyperglycemia-in-Type-2-Diabetes

Management of Hyperglycemia in Type 2 Diabetes, 2022. A ... High-quality evidence has consistently shown that DSMES significantly improves knowledge, glycemic levels, and clinical and psychological ...