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HOME DM-BAT: home-based diabetes-modified behavioral activation treatment for low-income seniors with type 2 diabetes-study protocol for a randomized controlled trial. Trials 2021 Nov 08;22(1):787

Date

11/10/2021

Pubmed ID

34749788

Pubmed Central ID

PMC8574935

DOI

10.1186/s13063-021-05744-1

Scopus ID

2-s2.0-85118750454

Abstract

BACKGROUND: About 13% of African Americans and 13% of Hispanics have diabetes, compared to 8% of non-Hispanic Whites (NHWs). This is more pronounced in the elderly where about 25-30% of those aged 65 and older have diabetes. Studies have found associations between social determinants of health (SDoH) and increased incidence, prevalence, and burden of diabetes; however, few interventions have accounted for the context in which the elderly live by addressing SDoH. Specifically, psychosocial factors (such as cognitive dysfunction, functional impairment, and social isolation) impacting this population may be under-addressed due to numerous medical concerns addressed during the clinical visit. The long-term goal of the project is to identify strategies to improve glycemic control and reduce diabetes complications and mortality in African Americans and Hispanics/Latinos with type 2 diabetes.

METHODS: This is a 5-year prospective, randomized clinical trial, which will test the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with type 2 diabetes mellitus (T2DM) (HOME DM-BAT). Two hundred, aged 65 and older and with an HbA1c ≥8%, will be randomized into one of two groups: (1) an intervention using in-home, nurse telephone-delivered diabetes education, and behavioral activation or (2) a usual care group using in-home, nurse telephone-delivered, health education/supportive therapy. Participants will be followed for 12 months to ascertain the effect of the intervention on glycemic control, blood pressure, and low-density lipoprotein (LDL) cholesterol. The primary hypothesis is low-income, minority seniors with poorly controlled type 2 diabetes randomized to HOME DM-BAT will have significantly greater improvements in clinical outcomes at 12 months of follow-up compared to usual care.

DISCUSSION: Results from this study will provide important insight into the effectiveness of a home-based diabetes-modified behavioral activation treatment for low-income, minority seniors with uncontrolled type 2 diabetes mellitus and inform strategies to improve glycemic control and reduce diabetes complications in minority elderly with T2DM.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04203147 ). Registered on December 18, 2019, with the National Institutes of Health Clinical Trials Registry.

Author List

Egede LE, Davidson TM, Knapp RG, Walker RJ, Williams JS, Dismuke CE, Dawson AZ

Authors

Aprill Z. Dawson PhD, MPH Assistant Professor in the Medicine department at Medical College of Wisconsin
Leonard E. Egede MD Center Director, Chief, Professor in the Medicine department at Medical College of Wisconsin
Rebekah Walker PhD Associate Professor in the Medicine department at Medical College of Wisconsin




MESH terms used to index this publication - Major topics in bold

African Americans
Aged
Diabetes Mellitus, Type 2
Humans
Poverty
Prospective Studies
Randomized Controlled Trials as Topic
Telephone