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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

145 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-25

Study Completion Date

2024-08-31

Brief Summary

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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.

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Detailed Description

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Thirty percent of African Americans (AAs) with Mild Cognitive Impairment (MCI) have (DM), which increases risk for cognitive decline and dementia. Poorly controlled DM magnifies this risk, and AAs have worse glycemic control than Whites. This single-site, double-blind, active-control, phase II randomized controlled trial (RCT) will compare the efficacy of DM-Specific Behavioral Activation (DM-BA) vs. Enhanced Usual Care (EUC) to prevent decline in verbal memory (primary outcome) over 2 years in 200 AAs over age 65 years with amnestic multiple-domain MCI and poorly controlled DM. DM-BA is a behavioral treatment for DM, as well as a secondary prevention strategy for dementia. DM-BA reinforces DM self-care and addresses negative beliefs about medications and physicians. In DM-BA, race-concordant community health workers (CHWs) will: 1) deliver in-home DM education tailored to AAs with MCI; 2) use action plans to reinforce DM self-care; 3) facilitate telehealth visits with a DM nurse educator to guide management of DM 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. The control treatment, EUC, is usual medical care enhanced with DM self-care education. Both DM-BA and EUC deliver DM education and have the same number of in-home treatment visits (i.e., 6 visits over 6 months, and 5 booster visits over the next 18 months). EUC, however, does not include DM-BA's behavioral approach to improve glycemic control, telehealth visits with a DM nurse educator, or PCP communication. The treatment comparison will identify DM-BA's specific efficacy over and above EUC. Randomization will follow a fixed scheme with a 1:1 allocation ratio and stratification by hemoglobin A1c level (7.5% - 9% vs. ≥ 9%). We are recruiting participants from primary care practices. We will administer the Hopkins Verbal Learning Test-Revised (HVLT-R) (to assess verbal memory; the primary outcome) and the Uniform Data Set neuropsychological battery (to assess executive function, processing speed, language, visuospatial function, and global cognition; all exploratory outcomes) at baseline and months 6, 12, 18, and 24. The primary efficacy analysis will compare trajectories in HVLT-R Total Recall scores over 2 years by treatment group. A novel exploratory aim will investigate whether Optical Coherence Tomography (OCT) measures of retinal Vessel Area Density (an indicator of microvascular disease) and/or Retinal Nerve Fiber Layer thickness (an indicator of neurodegeneration) \[i.e., proxies for cerebral microvascular and neurodegenerative disease, respectively\] mediate treatment effects. We will also explore whether APOE genotype moderates treatment effects, and explore DM-BA's impact on multiple cognitive domains and incidence rates of dementia. We powered this RCT to test the hypothesis that the slope of the trajectory of HVLT-R Total Recall scores in DM-BA participants will not differ significantly from 0 (i.e., no change), whereas the slope of the trajectory of HVLT-R Total Recall scores in EUC controls will be significantly negative (i.e., decline) over 2 years. With 25% attrition over 2 years, a randomized sample of 200 participants will provide over 80% power for detecting an annual 1-point difference in slopes (2-point difference in 2-year means; a clinically meaningful difference) at the two-sided alpha=0.05 level. The scientific rigor of this study derives from the double-blind RCT design; recruitment of a sample at high risk for cognitive decline; use of validated outcome measures; adequate power; masked outcome assessments; delivery of two standardized credible interventions, and data already demonstrating DM-BA's effectiveness to improve glycemic control. This RCT is innovative because it will determine whether improving glycemic control prevents cognitive decline in a high risk population. Previous RCTs have studied lower risk populations and have been inconclusive. We will also uniquely explore whether OCT-evidence of retinal microvascular disease and/or neurodegeneration mediate treatment effects. This RCT is significant because it targets two prevalent problems in older AAs with DM (i.e., poor glycemic control and dementia). AAs' high risk for this comorbidity emerges in part from cultural factors (e.g., health beliefs) and requires culturally relevant treatment. The number of older AAs with DM in the U.S. (now 1 million) will double by 2030. This doubling will increase the burden of dementia in AAs (who already have twice the rate of dementia as Whites) and necessitates preventive treatment. We have the experience and expertise to test this treatment, and the opportunity to change how DM is treated to prevent cognitive decline in AAs with DM. If successful, this RCT will bring us closer to achieving health equity for all Americans and meet the goals of the National Alzheimer's Project Act.

Conditions

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Mild Cognitive Impairment Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

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.

Study Groups

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Diabetes Regulation for Eyesight and Memory (DREAM)

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 Type EXPERIMENTAL

Diabetes Regulation for Eyesight and Memory

Intervention Type 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.

Enhanced Usual Care (EUC)

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

Group Type ACTIVE_COMPARATOR

Enhanced Usual Care

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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DREAM EUC

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

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

Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No