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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

Age ≥ 65 years

Type 2 DM

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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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 had diabetes for at least one year.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Decline in Verbal Memory

Other study objectives

Dementia

Glycemic Control

Retinal Nerve Fiber Layer Thickness Layer thickness mediates treatment effects;

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 4Eligibility criteria met