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Enhanced Usual Care for Diabetes and Cognitive Health for Mild Cognitive Impairment (DREAM Trial)

Phase 2
Recruiting
Led By Barry Rovner, MD
Research Sponsored by Thomas Jefferson University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Type 2 DM
Age ≥ 65 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights

DREAM Trial Summary

This trial will test if the DREAM program can help African Americans with poorly controlled diabetes and mild cognitive decline. The primary outcome is decline in verbal memory over 2 years, and follow-up data will be collected at 6, 12, 18, and 24 months.

Who is the study for?
This trial is for African Americans aged 65 or older with Type 2 diabetes and mild cognitive impairment. Participants must have a hemoglobin A1c level of at least 7.5% and be able to give written consent. Those with psychiatric disorders, dementia, certain medical conditions, or a life expectancy under two years are not eligible.Check my eligibility
What is being tested?
The study compares the DREAM program (home sessions and telehealth visits focused on managing diabetes to preserve memory) against Enhanced Usual Care (standard care plus home-based education). The goal is to see if DREAM can prevent cognitive decline over two years in participants.See study design
What are the potential side effects?
Since this trial involves educational interventions rather than medications, traditional side effects are not expected. However, there may be indirect effects related to changes in diabetes management.

DREAM Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have type 2 diabetes.
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I am 65 years old or older.
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I have type 2 diabetes.
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I have been diagnosed with a specific type of memory loss affecting several areas.
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I have been diagnosed with a specific type of memory loss affecting several areas.
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I have had diabetes for at least one year.
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I have been diagnosed with a specific type of memory loss affecting several areas.
Select...
I have type 2 diabetes.
Select...
I have had diabetes for at least one year.
Select...
I am 65 years old or older.

DREAM Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Decline in Verbal Memory
Other outcome measures
Dementia
Glycemic Control
Retinal Nerve Fiber Layer Thickness Layer thickness mediates treatment effects;
+1 more

DREAM Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Diabetes Regulation for Eyesight and Memory (DREAM)Experimental Treatment1 Intervention
DREAM is a behavioral treatment for diabetes mellitus (DM), as well as a secondary prevention strategy for dementia. DREAM acts to reinforce DM self-care and address negative beliefs about medications and physicians, which compromise glycemic control in African Americans (AAs). In DREAM, race-concordant community health workers (CHWs) will: 1) deliver in-home DM education tailored to AAs with MCI; 2) use action plans to reinforce diabetes self-care; 3) facilitate telehealth visits with a DM nurse educator to improve DM self-care and address participants' health beliefs; and 4) increase primary care physicians' (PCP) awareness of participants' cognitive deficits and health beliefs to optimize treatment of DM. .
Group II: Enhanced Usual Care (EUC)Active Control1 Intervention
EUC consists of home visits by a CHW in which general DM education is provided.

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
443 Previous Clinical Trials
145,300 Total Patients Enrolled
2 Trials studying Diabetes
400 Patients Enrolled for Diabetes
Barry Rovner, MDPrincipal InvestigatorThomas Jefferson University
2 Previous Clinical Trials
240 Total Patients Enrolled
1 Trials studying Diabetes
200 Patients Enrolled for Diabetes

Media Library

Diabetes Regulation for Eyesight and Memory Clinical Trial Eligibility Overview. Trial Name: NCT04259047 — Phase 2
Diabetes Research Study Groups: Diabetes Regulation for Eyesight and Memory (DREAM), Enhanced Usual Care (EUC)
Diabetes Clinical Trial 2023: Diabetes Regulation for Eyesight and Memory Highlights & Side Effects. Trial Name: NCT04259047 — Phase 2
Diabetes Regulation for Eyesight and Memory 2023 Treatment Timeline for Medical Study. Trial Name: NCT04259047 — Phase 2

Frequently Asked Questions

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

How many participants is this trial recruiting?

"Affirmative. According to clinicaltrials.gov, the trial which was initially advertised on October 25th 2021 is still actively looking for 200 patients from a single medical facility. The post was last amended December 15th of this year."

Answered by AI

Has the FDA certified Diabetes Regulation for Eyesight and Memory?

"The safety of Diabetes Regulation for Eyesight and Memory was rated a 2 due to the phase two status, meaning that efficacy has yet to be demonstrated in clinical trials but there is some safety data available."

Answered by AI

Are there any available slots for prospective participants in this trial?

"Affirmative. Clinicaltrials.gov has data demonstrating that the medical experiment, which was first posted on October 25th 2021, is still recruiting participants. 200 people are needed to be enrolled from 1 centre of research."

Answered by AI

Who else is applying?

What state do they live in?
Pennsylvania
How old are they?
18 - 65
What site did they apply to?
Thomas Jefferson University
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
~51 spots leftby Jan 2025