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

NCT04259047 | Completed Phase 2 DMC

• 1 other identifier: R01AG065467
• Study Type: interventional
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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

Mild Cognitive Impairment; Diabetes

Keywords

Mild Cognitive Impairment; Diabetes; African American; Health Disparities; Retinal Imaging

Outcome Measures

Primary Outcomes (1)

• Decline in Verbal Memory

  Scores on the Hopkins Verbal Learning Test total recall (HVLT)

  24 months

Other Outcomes (4)

• Glycemic Control

  24 months

• Retinal Vessel Area Density Layer thickness mediates treatment effects;

  24 months

• Retinal Nerve Fiber Layer Thickness Layer thickness mediates treatment effects;

  24 months

Study Arms (2)

Diabetes Regulation for Eyesight and Memory (DREAM)

EXPERIMENTAL

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. .

Behavioral: Diabetes Regulation for Eyesight and Memory

Enhanced Usual Care (EUC)

ACTIVE COMPARATOR

EUC consists of home visits by a CHW in which general DM education is provided.

Behavioral: Enhanced Usual Care

Interventions

Diabetes Regulation for Eyesight and Memory BEHAVIORAL

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.

Also known as: DREAM

Diabetes Regulation for Eyesight and Memory (DREAM)

Enhanced Usual Care BEHAVIORAL

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.

Also known as: EUC

Enhanced Usual Care (EUC)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• African American race
• Age ≥ 65 years
• Type 2 DM
• Duration of DM ≥ 1 year
• HbA1c ≥ 7.5
• Amnestic multiple-domain MCI by NIA-AA criteria
• Able to provide written informed consent

You may not qualify if:

• Dementia
• Excluded medical conditions
• Life expectancy less than two years in the opinion of the PCP
• Psychiatric disorders
• Cannot provide written consent

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (1)

• Casten R, Leiby BE, Kelley M, Rovner BW. A randomized controlled trial to test the efficacy of a diabetes behavioral intervention to prevent memory decline in older blacks/African Americans with diabetes and mild cognitive impairment. Contemp Clin Trials. 2022 Dec;123:106977. doi: 10.1016/j.cct.2022.106977. Epub 2022 Oct 28.

  PMID: 36341847 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Barry Rovner, MD

  Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This RCT will be double-masked in that all participants will receive an active intervention, and investigators and outcome assessors will be masked to treatment assignment. To maintain masking: 1) the Outcome Assessor will be masked to treatment assignment; 2) interventionists who deliver study treatments gather no outcome data; and 3) only primary care physicians (PCPs) who treat participants in the active group\[, and the Study Coordinator, Project Director, and Statistician will be unmasked. Because the 2 interventions (DREAM and EUC) share identifying characteristics (i.e., in-home delivery by CHWs, same educational materials, same visit frequency), the risk of unmasking is reduced. At each outcome assessment, the Outcome Assessor will instruct participants on the purpose and importance of maintaining masking, and will request that they reveal no information about their study participation.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 6, 2020
• Study Start: October 25, 2021
• Primary Completion: August 31, 2024
• Study Completion: August 31, 2024
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)