- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06736431
Bringing Advocacy Via Digital Guide to the Emergency Department (Project BADGE)
April 23, 2026 updated by: Sara Heinert, PhD, MPH, Rutgers, The State University of New Jersey
The pilot study of Project BADGE will focus on emergency department (ED) patients with diabetes, which has significant disparities in prevalence and mortality for underserved populations.
The objective is to determine the effect of a text-based resource referral platform with diabetes educational materials on patient diabetes knowledge, diabetes distress, diabetes self-care activities, and acceptability and feasibility of the intervention.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New Jersey
-
New Brunswick, New Jersey, United States, 08901
- Robert Wood Johnson University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Adult (18+) ED/observation unit patients
- Have poorly controlled or new onset diabetes (hyperglycemia or Diabetic ketoacidosis (DKA))
- Speak English or Spanish
- Has a cell phone able to send and receive text messages
Exclusion Criteria:
1) Intubated patient
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Text-based platform
Text-based resource referral platform with diabetes educational materials
|
Text-based resource referral platform with diabetes educational materials
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Doctor Visit
Time Frame: 3 months
|
Did the patient attend a doctor appointment?
|
3 months
|
|
Diabetes Distress
Time Frame: Baseline, 3 months
|
2-item Diabetes Distress Scale (DDS2)- if positive on DDS2, will complete DDS17 (On a scale of 1- "not a problem" to 6- "a very serious problem.")
|
Baseline, 3 months
|
|
Diabetes Knowledge
Time Frame: Baseline, 3 months
|
Diabetes Knowledge Questionnaire, with response choices of Yes, No, or I Don't Know
|
Baseline, 3 months
|
|
Diabetes Self-Care
Time Frame: Baseline, 3 months
|
Diabetes Self-Care Assessment, which asks about ask you about diabetes self-care activities during the past 7 days.
|
Baseline, 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intervention Acceptability
Time Frame: 3 months
|
Acceptability of Intervention Measure (AIM) on a scale of 1 (completely disagree) to 5 (completely agree)
|
3 months
|
|
Intervention Feasibility
Time Frame: 3 months
|
Feasibility of Intervention Measure (FIM) on a scale of 1 (completely disagree) to 5 (completely agree)
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2025
Primary Completion (Actual)
March 3, 2026
Study Completion (Actual)
March 24, 2026
Study Registration Dates
First Submitted
December 13, 2024
First Submitted That Met QC Criteria
December 13, 2024
First Posted (Actual)
December 16, 2024
Study Record Updates
Last Update Posted (Actual)
April 29, 2026
Last Update Submitted That Met QC Criteria
April 23, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro2024001476
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.