Enhancing Preventative Health Behaviors Among Emergency Department Hyperglycemic Patients

NCT06663813 | Recruiting

• 1 other identifier: Pro2024000602
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this clinical trial is to increase Type 2 Diabetes Mellitus knowledge and awareness among patients who present to the Emergency Department with hyperglycemia. The main questions it aims to answer are:

• How do patients view their risk of developing type 2 diabetes based on their demographics and behaviors?
• Does giving patient education increase patient knowledge, leading to healthier behaviors? Researchers will assess if the educational intervention increases diabetes knowledge and positive health behaviors among Emergency Department hyperglycemic patients. Participants will:
• Receive the educational packet (intervention) alongside standard Emergency Care.
• Take pre-survey at time of Emergency Department visit and post- survey two weeks later.

Conditions

Type 2 Diabetes; Hyperglycemia

Keywords

Emergency Medicine; Type 2 Diabetes; Hyperglycemia

Outcome Measures

Primary Outcomes (1)

• Diabetes Knowledge

  Changes in self-perceived susceptibility, severity, benefits, and barriers to managing T2DM, aligned with the Health Belief Model

  Initial Emergency Department presentation to follow-up survey (2 weeks later)

Secondary Outcomes (1)

• Proactive and Preventative Health Behaviors

  Initial Emergency Department presentation to follow-up survey (2 weeks later)

Study Arms (1)

Intervention Arm

EXPERIMENTAL

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.

Behavioral: Educational Intervention

Interventions

Educational Intervention BEHAVIORAL

Utilizing the Health Belief model, educational materials detailing diabetes risk factors to address perceived susceptibility, diabetes severity and complications to address perceived severity, and PCP follow-up information and medication assistance programs to address perceived barriers will be provided.

Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Persons 18 years of age or older who present as patients in the Robert Wood Johnson University Hospital Emergency Department with or without a preexisting Type 2 Diabetes Mellitus diagnosis with a blood glucose of ≥200 mg/dL. Participants must speak English to participate in the study.

You may not qualify if:

• Age less than 18 years and blood glucose \<200 mg/dL.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (2)

One Robert Wood Johnson Place

New Brunswick, New Jersey, 08540, United States

RECRUITING

One Robert Wood Johnson Place

New Brunswick, New Jersey, 08901, United States

RECRUITING

Related Links

• This research table demonstrates that T2DM is currently the most prevalent chronic disease encountered in the ED.
• Describes the tenants of the Health Belief Model

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Officials

• Sara Heinert, PhD, MPH

  Rutgers Robert Wood Johnson Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Neha V Maddali, BSPH

CONTACT

9739758066; nvm37@rwjms.rutgers.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Director of Research; Assistant Professor at the Department of Emergency Medicine

Study Record Dates

• First Submitted: October 25, 2024
• First Posted: October 29, 2024
• Study Start: October 29, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: December 18, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Due to the nature of the data being collected, and to ensure participant confidentiality, data will be made available using a tiered request for access system. All tiers of data require a data-use agreement (DUA) at a minimum, additional precautions for restricted-use will be included in data request forms.

Locations

US (2)