Type 2 DiabetesNCT06663813
Enhancing Preventative Health Behaviors Among Emergency Department Hyperglycemic Patients
A study testing Educational Intervention in people with Type 2 Diabetes and Hyperglycemia, run by Rutgers, The State University of New Jersey at 2 sites in United States.
Trial 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?… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes, Hyperglycemia
- What is being tested?
- Educational Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 2 sitesUnited States
- Study dates
- 29 Oct 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age less than 18 years and blood glucose \<200 mg/dL.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
One Robert Wood Johnson Place
New Brunswick, New Jersey, 08540
Sara Heinert, PhD, MPH, 732-235-7872, sara.heinert@rutgers.edu
- Recruiting
One Robert Wood Johnson Place
New Brunswick, New Jersey, 08901
Sara Heinert, PhD, MPH, 732-235-7872, sara.heinert@rutgers.edu
About this study
Official title: Enhancing Proactive and Preventative Health Behaviors Among Hyperglycemic Patients Presenting to the Emergency Department
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?
Read more
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.
Read the 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.
- Conditions
- Type 2 Diabetes, Hyperglycemia
- Being tested
- Educational Intervention
- Keywords
- Emergency Medicine, Type 2 Diabetes, Hyperglycemia
- Medical subject headings
- Diabetes Mellitus, Type 2, Hyperglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational InterventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Educational Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes Knowledge
Changes in self-perceived susceptibility, severity, benefits, and barriers to managing T2DM, aligned with the Health Belief Model
Measured: Initial Emergency Department presentation to follow-up survey (2 weeks later)
Secondary outcomes (1)
Proactive and Preventative Health Behaviors
Behavioral changes, which include presence of PCP follow-up, establishing a new PCP, and utilizing medication assistance programs.
Measured: Initial Emergency Department presentation to follow-up survey (2 weeks later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2024
- Study start29 Oct 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Heinert, PhD, MPH, Rutgers, The State University of New Jersey
- Investigators
- Sara Heinert, PhD, MPH, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06663813
- Sponsor's protocol ID
- Pro2024000602
- Status last verified
- Dec 2024
- First submitted
- 25 Oct 2024
- Last updated
- 18 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie the results reported in this article, after deidentification (including text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Proactive and Preventative Health Behaviors Among Hyperglycemic Patients Presenting to the Emergency Department
- ClinicalTrials.gov ID
- NCT06663813
- Acronym / sponsor ID
- Pro2024000602
- Conditions
- Type 2 Diabetes, Hyperglycemia
- Keywords
- Emergency Medicine, Type 2 Diabetes, Hyperglycemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- 29 Oct 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 29 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Educational InterventionParticipants 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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Age less than 18 years and blood glucose \<200 mg/dL.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational InterventionUtilizing 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. | Behavioural | Intervention Arm |
Primary outcome
Diabetes Knowledge
Time frame: Initial Emergency Department presentation to follow-up survey (2 weeks later)
Changes in self-perceived susceptibility, severity, benefits, and barriers to managing T2DM, aligned with the Health Belief Model
1 secondary outcome
Proactive and Preventative Health Behaviors
Time frame: Initial Emergency Department presentation to follow-up survey (2 weeks later)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2024.
- This research table demonstrates that T2DM is currently the most prevalent chronic disease encountered in the ED.Link provided by the sponsor.
- Describes the tenants of the Health Belief ModelLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. IPD that underlie the results reported in this article, after deidentification (including text, tables, figures, and appendices).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sara Heinert, PhD, MPH principal investigator
Rutgers Robert Wood Johnson Medical School
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational Intervention in people with Type 2 Diabetes and Hyperglycemia, run by Rutgers, The State University of New Jersey at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neha V Maddali, BSPH (9739758066, nvm37@rwjms.rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetes Knowledge (time frame: Initial Emergency Department presentation to follow-up survey (2 weeks later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.