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PREVENT (Preventing and Reducing Emergency Visits in Diabetes through Education and Telehealth) for Diabetes (PREVENT Trial)
Phase 3
Waitlist Available
Led By Barry W Rovner
Research Sponsored by Thomas Jefferson University
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 12 months
Awards & highlights
PREVENT Trial Summary
This trial will compare the PREVENT intervention to intensive home-based diabetes education (EUC) to see if PREVENT can reduce diabetes-related emergency department visits and/or hospitalizations.
Eligible Conditions
- Diabetes
PREVENT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Incident Diabetes-related ED Visits and/or Hospitalizations
Secondary outcome measures
Actual Access to Care
Change From Baseline to 12 Months on Diabetes Self-Care Inventory Scores
Perceived Access to Health Care
Side effects data
From 2023 Phase 3 trial • 156 Patients • NCT0346686621%
Cardiac
13%
Gastrointestinal
12%
Infection
8%
Neurological (excluding stroke)
8%
Diabetes-related
8%
Pulmonary
6%
musculoskeletal
4%
renal
4%
Blood disorders
4%
shortness of breath
3%
Stroke
3%
COPD
1%
metabolic-not diabetes related
1%
psychiatric
1%
Respiratory
1%
Surgical
100%
80%
60%
40%
20%
0%
Study treatment Arm
EUC (Enhanced Usual Care)
PREVENT (Preventing and Reducing Emergency Visits in Diabetes Through Education and Telehealth)
PREVENT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PREVENT (Preventing and Reducing Emergency Visits in Diabetes through Education and Telehealth)Experimental Treatment1 Intervention
Community Health Workers (CHWs), who are race-concordant with participants, will: 1) deliver in-home DM education to increase participants' knowledge and skills; 2) use DM-specific Behavioral Activation to improve DM self-care; and 3) facilitate telehealth visits with the participant's primary care physician (PCP) and a DM nurse educator to increase access to care.
Group II: EUC (Enhanced Usual Care)Active Control1 Intervention
In-home diabetes education with no goal setting or telehealth visits
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
PREVENT
2016
Completed Phase 3
~260
Find a Location
Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
448 Previous Clinical Trials
147,606 Total Patients Enrolled
3 Trials studying Diabetes
600 Patients Enrolled for Diabetes
Barry W RovnerPrincipal InvestigatorThomas Jefferson University
Barry w RovnerPrincipal InvestigatorThomas Jefferson University
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a significant problem with memory or thinking that affects your daily life.You have either Type 1 or Type 2 diabetes.You visited the emergency department due to an issue related to diabetes, as determined by the emergency department doctor.You identify as an African American.You have a medical or mental health condition that the emergency department doctor thinks would make it difficult for you to participate in the study.You are pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: PREVENT (Preventing and Reducing Emergency Visits in Diabetes through Education and Telehealth)
- Group 2: EUC (Enhanced Usual Care)
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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