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COPDE 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
Diabetes self-care behaviors
Perceived access to health care
PREVENT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: COPDEExperimental 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: Intensive Diabetes EducationActive Control1 Intervention
In-home diabetes education
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Who is running the clinical trial?
Thomas Jefferson UniversityLead Sponsor
445 Previous Clinical Trials
145,558 Total Patients Enrolled
3 Trials studying Diabetes
600 Patients Enrolled for Diabetes
Barry w RovnerPrincipal InvestigatorThomas Jefferson University
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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: COPDE
- Group 2: Intensive Diabetes Education
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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