NCT06736431

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable diabetes

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 16, 2024

Completed
7 months until next milestone

Study Start

First participant enrolled

July 15, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 3, 2026

Completed
21 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2026

Completed
Last Updated

April 29, 2026

Status Verified

April 1, 2026

Enrollment Period

8 months

First QC Date

December 13, 2024

Last Update Submit

April 23, 2026

Conditions

Diabetes

Outcome Measures

Primary Outcomes (4)

  • Diabetes Distress

    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

    Diabetes Knowledge Questionnaire, with response choices of Yes, No, or I Don't Know

    Baseline, 3 months

  • Diabetes Self-Care

    Diabetes Self-Care Assessment, which asks about ask you about diabetes self-care activities during the past 7 days.

    Baseline, 3 months

  • Doctor Visit

    Did the patient attend a doctor appointment?

    3 months

Secondary Outcomes (2)

  • Intervention Acceptability

    3 months

  • Intervention Feasibility

    3 months

Study Arms (1)

Text-based platform

EXPERIMENTAL

Text-based resource referral platform with diabetes educational materials

Behavioral: Text-based resource referral platform with diabetes educational materials

Interventions

Text-based resource referral platform with diabetes educational materialsBEHAVIORAL

Text-based resource referral platform with diabetes educational materials

Text-based platform

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \) Intubated patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robert Wood Johnson University Hospital

New Brunswick, New Jersey, 08901, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 13, 2024

First Posted

December 16, 2024

Study Start

July 15, 2025

Primary Completion

March 3, 2026

Study Completion

March 24, 2026

Last Updated

April 29, 2026

Record last verified: 2026-04

Locations

US(1)