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Health Beliefs, Glycemic Control, and Preventing Cognitive Decline in African Americans with Diabetes and Mild Cognitive Impairment: a Randomized Clinical Trial

NCT04259047 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 145

Last updated 2024-11-21

No results posted yet for this study

Summary

This double-masked, 2-year, single-site, phase II RCT will test the efficacy of DREAM (Diabetes Regulation for Eye Sight and Memory to prevent cognitive decline in African Americans (AAs) with amnestic multiple domain mild cognitive impairment (MCI) and poorly controlled diabetes (i.e., hemoglobin A1c \[HbA1c\] level ≥ 7.5%). Participants will be randomized to DREAM \[11 home-based treatment sessions with a community health worker (CHW), and 4 telehealth visits with a Diabetes Nurse Educator over 2 years\] or Enhanced Usual Care (EUC), which is usual care enhanced with home-based diabetes education. The primary outcome is decline in verbal memory over 2 years. Follow-up data will be collected at 6, 12, 18, and 24 months. In addition, participants will have ophthalmology assessments (at Wills) at baseline, 12 and 24 months to determine whether retinal Vessel Area Density, and/or Retinal Nerve Fiber Layer thickness mediate DREAM's treatment effect.

Conditions

Interventions

BEHAVIORAL

Diabetes Regulation for Eyesight and Memory

Participants randomized to DREAM will have 11 in-home visits over 2 years with a CHW, and 4 telehealth visits with a DM nurse educator.

BEHAVIORAL

Enhanced Usual Care

Participants in this group will have 11 in-home CHW visits over 24 months to control for attention. During these visits, the CHW will provide general diabetes education. There will be no telehealth visits.

Sponsors & Collaborators

  • Thomas Jefferson University

    lead OTHER

Principal Investigators

  • Barry Rovner, MD · Thomas Jefferson University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-25
Primary Completion
2024-08-31
Completion
2024-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04259047 on ClinicalTrials.gov