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Recruiting NCT06663813

Enhancing Preventative Health Behaviors Among Emergency Department Hyperglycemic Patients

No phase Interventional Type 2 Diabetes Hyperglycemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Educational Intervention.
Who it may be relevant to
Registry conditions: Type 2 Diabetes, Hyperglycemia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Enhancing Proactive and Preventative Health Behaviors Among Hyperglycemic Patients Presenting to the Emergency Department

Overview

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

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.

Interventions

  • Behavioral 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.

Primary outcome measures

  • Diabetes Knowledge [Time frame: Initial Emergency Department presentation to follow-up survey (2 weeks later)]
Secondary outcome measures (1)
  • Proactive and Preventative Health Behaviors [Time frame: Initial Emergency Department presentation to follow-up survey (2 weeks later)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

United States · 2 centers
  • One Robert Wood Johnson Place — New Brunswick
  • One Robert Wood Johnson Place — New Brunswick

Identifiers

NCT: NCT06663813 · Pro2024000602

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗