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.
Alzheimer's disease
Dementia
Diabetes
Health disparities
Journal
Contemporary clinical trials
ISSN: 1559-2030
Titre abrégé: Contemp Clin Trials
Pays: United States
ID NLM: 101242342
Informations de publication
Date de publication:
12 2022
12 2022
Historique:
received:
14
07
2022
revised:
24
10
2022
accepted:
25
10
2022
pubmed:
8
11
2022
medline:
7
12
2022
entrez:
7
11
2022
Statut:
ppublish
Résumé
The prevalence of dementia in Blacks/African Americans (AAs) is almost twice that of Whites. Inequities in access to health care, socioeconomic conditions, and diabetes contribute to this disparity. Poorly controlled diabetes, which is more prevalent in Blacks/AAs, causes microvascular disease and neurodegeneration and increases dementia risk. Improving glycemic control, therefore, may prevent cognitive decline. To address this issue, we developed Diabetes Regulation for Eyesight and Memory (DREAM), a community health worker (CHW)-led behavioral intervention to improve diabetes self-management and thereby prevent cognitive decline. DREAM consists of home-based diabetes education, goal setting, and telehealth visits with a diabetes nurse educator. Exploratory aims will investigate whether APOE genotype moderates and retinal biomarkers mediate treatment effects. This report describes the trial's rationale, methodology, and study procedures. (clinicaltrials.gov identifier NCT04259047). This randomized controlled trial will test the efficacy of DREAM to prevent decline in memory (primary outcome) in Blacks/AAs aged 65+ with poorly controlled diabetes and Mild Cognitive Impairment (MCI). Two hundred participants will be randomized to DREAM or an attention control condition, and will receive 11 in-home treatment sessions over two years. Outcome data are collected at 6, 12, 18, and 24 months. The primary outcome is verbal learning as measured by Hopkins Verbal Learning Test (HVLT) Total Recall scores. Participants will have retinal imaging at baseline, 12, and 24 months. This research aims to prevent cognitive decline in older Blacks/AAs with diabetes and MCI. If successful, this research will preserve health in an underserved population and reduce racial health disparities.
Sections du résumé
BACKGROUND
The prevalence of dementia in Blacks/African Americans (AAs) is almost twice that of Whites. Inequities in access to health care, socioeconomic conditions, and diabetes contribute to this disparity. Poorly controlled diabetes, which is more prevalent in Blacks/AAs, causes microvascular disease and neurodegeneration and increases dementia risk. Improving glycemic control, therefore, may prevent cognitive decline. To address this issue, we developed Diabetes Regulation for Eyesight and Memory (DREAM), a community health worker (CHW)-led behavioral intervention to improve diabetes self-management and thereby prevent cognitive decline. DREAM consists of home-based diabetes education, goal setting, and telehealth visits with a diabetes nurse educator. Exploratory aims will investigate whether APOE genotype moderates and retinal biomarkers mediate treatment effects. This report describes the trial's rationale, methodology, and study procedures. (clinicaltrials.gov identifier NCT04259047).
METHODS
This randomized controlled trial will test the efficacy of DREAM to prevent decline in memory (primary outcome) in Blacks/AAs aged 65+ with poorly controlled diabetes and Mild Cognitive Impairment (MCI). Two hundred participants will be randomized to DREAM or an attention control condition, and will receive 11 in-home treatment sessions over two years. Outcome data are collected at 6, 12, 18, and 24 months. The primary outcome is verbal learning as measured by Hopkins Verbal Learning Test (HVLT) Total Recall scores. Participants will have retinal imaging at baseline, 12, and 24 months.
CONCLUSIONS
This research aims to prevent cognitive decline in older Blacks/AAs with diabetes and MCI. If successful, this research will preserve health in an underserved population and reduce racial health disparities.
Identifiants
pubmed: 36341847
pii: S1551-7144(22)00303-2
doi: 10.1016/j.cct.2022.106977
pmc: PMC9787831
mid: NIHMS1859388
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04259047']
Types de publication
Randomized Controlled Trial
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Sous-ensembles de citation
IM
Pagination
106977Subventions
Organisme : NIDDK NIH HHS
ID : P30 DK111022
Pays : United States
Organisme : NIA NIH HHS
ID : R01 AG065467
Pays : United States
Informations de copyright
Copyright © 2022 Elsevier Inc. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of Competing Interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.
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