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Diabetes Education and Management for Diabetes (PROMPT Trial)

N/A
Recruiting
Led By Katrina Donahue, MD, MPH
Research Sponsored by University of North Carolina, Chapel Hill
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, month 6
Awards & highlights

PROMPT Trial Summary

This trial seeks to improve referral & attendance to diabetes self-management services, by testing the best time points for referral & by conducting a pilot study to compare the effectiveness of peer support.

Who is the study for?
This trial is for adult, English-speaking patients with type 2 diabetes who are referred to Diabetes Self-Management Education and Support (DSMES) classes by primary care providers from the participating practices. Providers not employed at these practices or patients not referred to DSMES from them cannot join.Check my eligibility
What is being tested?
The study tests a Best Practice Advisory (BPA) timing strategy to maximize referrals to DSMES services and compares peer support's effectiveness in improving attendance at these services. It involves three steps: optimizing BPA timing, piloting peer support, and planning a larger trial.See study design
What are the potential side effects?
Since this trial focuses on education and management strategies rather than medication, it does not have typical medical side effects. However, participants may experience stress or time constraints due to additional commitments.

PROMPT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, month 6
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 6 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Odds of attending 1 DSMES class
Odds of referral for DSMES Placed through the Electronic Health Record (EHR)
Secondary outcome measures
A1c - Baseline
Change in A1c from baseline to 3 months
Change in A1c from baseline to 6 months
+10 more

PROMPT Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: 3. Peer SupportExperimental Treatment1 Intervention
45 patients in the 6 clinics who are referred to DSMES classes who enroll in the study will be assigned a peer supporter who will work with the participant and encourage attendance to the DSMES classes in addition to the usual support offered by the clinic.
Group II: 1. Best Practice AdvisoryExperimental Treatment1 Intervention
Four practices receive a suite of tools intended to increase the rate of referral to DSMES classes for patients with type 2 diabetes. In these four practices, the assigned DCE specialist will have access to a list of eligible patients who have upcoming appointments with their primary care providers. The DCE specialist will message the providers about the eligible patients via the EHR. They will also place a pended order for referral to DSMES class for the eligible patients. The health care provider will be able to either approve or deny the order for the referral Additionally, when an eligible patient presents for an appointment in one of the four intervention clinics, a best practice advisory (BPA) will fire within the EHR and encourage the provider to place a referral for DSMES classes.
Group III: 4. Usual CarePlacebo Group1 Intervention
45 patients in the 6 clinics who are referred to DSMES classes who enroll in the study will receive the usual support offered by the clinic.
Group IV: 2. Silent Best Practice AdvisoryPlacebo Group1 Intervention
Two practices will not receive the suite of tools, but the lists and BPA will be created and sent to the research team.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Best Practice Advisory
2022
N/A
~160
Peer Support
2011
N/A
~4780

Find a Location

Who is running the clinical trial?

University of North Carolina, Chapel HillLead Sponsor
1,510 Previous Clinical Trials
4,193,003 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,365 Previous Clinical Trials
4,316,112 Total Patients Enrolled
Katrina Donahue, MD, MPHPrincipal InvestigatorUNC Chapel Hill

Media Library

1. Best Practice Advisory Clinical Trial Eligibility Overview. Trial Name: NCT05587348 — N/A
Type 2 Diabetes Research Study Groups: 4. Usual Care, 2. Silent Best Practice Advisory, 1. Best Practice Advisory, 3. Peer Support
Type 2 Diabetes Clinical Trial 2023: 1. Best Practice Advisory Highlights & Side Effects. Trial Name: NCT05587348 — N/A
1. Best Practice Advisory 2023 Treatment Timeline for Medical Study. Trial Name: NCT05587348 — N/A
Type 2 Diabetes Patient Testimony for trial: Trial Name: NCT05587348 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the primary aim of this scientific research?

"This trial, spanning 30 days in duration, strives to ascertain the Odds of individuals attending one DSMES class. To further measure effectiveness, a Diabetes Distress Scale (DDS17) is employed at baseline and follow-up check ups for 3 months and 6 months respectively; this 17-item questionnaire assesses emotional burden, physician distress, regimen distress, and interpersonal distress."

Answered by AI

Is there still an opportunity to participate in this experiment?

"The data hosted on clinicaltrials.gov depicts that this particular medical trial is not actively recruiting patients as of the 18th October 2022. However, there are 1391 other studies currently searching for participants across various locations."

Answered by AI

Who else is applying?

How old are they?
18 - 65
What site did they apply to?
University of North Carolina at Chapel Hill
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
What state do they live in?
Mississippi
Pennsylvania
How many prior treatments have patients received?
1
3+
2

What questions have other patients asked about this trial?

Why did patients apply to this trial?

I would like to reduce my medications. to contribute to this clinical trial to help myself and others.
PatientReceived 1 prior treatment
I have had a1C as high as 7.4. want to lose weight and bring my a1C below 6.0.
PatientReceived 1 prior treatment

How responsive is this trial?

Most responsive sites:
  1. University of North Carolina at Chapel Hill: < 24 hours
Average response time
  • < 1 Day
Typically responds via
Email
Recent research and studies
clinicaltrials.govStudy
PROmoting Diabetes Education and Management Through Peer Support and Team Referral
2023. "PROmoting Diabetes Education and Management Through Peer Support and Team Referral". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05587348.
~30 spots leftby Sep 2024
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