Enhancing Preventative Health Behaviors Among Emergency Department Hyperglycemic Patients

NCT ID: NCT06663813

Last Updated: 2024-12-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-29

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Despite the large prevalence of patients presenting to the Emergency Department (ED) with hyperglycemia or disease manifestations related to Type 2 Diabetes Mellitus (T2DM), there remains a gap in our understanding of rapid educational strategies delivered within the ED itself. As such, the goal of this project is to utilize the Health Belief Model (HBM) framework to target ED patients' perceived susceptibility, severity, benefits, and barriers in an effort to enhance proactive health behaviors, such as primary care physician (PCP) follow-up and utilization of medication assistance programs, among ED patients.

We will recruit 400 English speaking adults who present to the ED with a blood glucose of ≥200 mg/dL. All participants will receive educational materials on diabetes, as well as resources to local primary-care follow up and medication assistance programs. Participants will complete pre- and post-surveys to quantify changes in self-perceived susceptibility, severity, barriers to managing T2DM, and behavioral changes, which include presence of PCP follow-up, establishing a new PCP, and utilizing medication assistance programs.

Quantitative pre- and post-survey responses will be analyzed via regression models and paired t-tests to evaluate for statistically significant changes in perceived susceptibility, severity, benefits, and barriers to T2DM self-management among participants before and after receiving the educational intervention.The expected findings of this research study are increases in patient diabetes knowledge and self-perception of susceptibility and severity, leading to higher rates of PCP follow-up among participants following dissemination of educational materials grounded in the HBM framework. These research outcomes can be utilized to inform future interventions that target further barriers or reduce ED recidivism for hyperglycemic patients in the ED.

Conditions

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Type 2 Diabetes Hyperglycemia

Keywords

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Emergency Medicine Type 2 Diabetes Hyperglycemia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Intervention Arm

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.

Group Type EXPERIMENTAL

Educational Intervention

Intervention Type 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.

Interventions

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Educational Intervention

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 Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* Age less than 18 years and blood glucose \<200 mg/dL.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Sara Heinert, PhD, MPH

Co-Director of Research; Assistant Professor at the Department of Emergency Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sara Heinert, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

Rutgers Robert Wood Johnson Medical School

Locations

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One Robert Wood Johnson Place

New Brunswick, New Jersey, United States

Site Status RECRUITING

One Robert Wood Johnson Place

New Brunswick, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Neha V Maddali, BSPH

Role: CONTACT

Phone: 9739758066

Email: [email protected]

Facility Contacts

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Sara Heinert, PhD, MPH

Role: primary

Sara Heinert, PhD, MPH

Role: primary

Related Links

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https://archive.cdc.gov/www_cdc_gov/nchs/data/ahcd/nhamcs_emergency/2010_ed_web_tables.pdf

This research table demonstrates that T2DM is currently the most prevalent chronic disease encountered in the ED.

Other Identifiers

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Pro2024000602

Identifier Type: -

Identifier Source: org_study_id