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
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 heal...
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| Format: | Article |
| Language: | English |
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BMC
2021-11-01
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| Series: | Trials |
| Subjects: | |
| Online Access: | https://doi.org/10.1186/s13063-021-05744-1 |
| _version_ | 1819006310496075776 |
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| author | Leonard E. Egede Tatiana M. Davidson Rebecca G. Knapp Rebekah J. Walker Joni S. Williams Clara E. Dismuke Aprill Z. Dawson |
| author_facet | Leonard E. Egede Tatiana M. Davidson Rebecca G. Knapp Rebekah J. Walker Joni S. Williams Clara E. Dismuke Aprill Z. Dawson |
| author_sort | Leonard E. Egede |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-12-21T00:06:39Z |
| format | Article |
| id | doaj.art-529459c191324a39a9d77c88c034bd92 |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-12-21T00:06:39Z |
| publishDate | 2021-11-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-529459c191324a39a9d77c88c034bd922022-12-21T19:22:27ZengBMCTrials1745-62152021-11-0122111110.1186/s13063-021-05744-1HOME DM-BAT: home-based diabetes-modified behavioral activation treatment for low-income seniors with type 2 diabetes—study protocol for a randomized controlled trialLeonard E. Egede0Tatiana M. Davidson1Rebecca G. Knapp2Rebekah J. Walker3Joni S. Williams4Clara E. Dismuke5Aprill Z. Dawson6Department of Medicine, Division of General Internal Medicine, Medical College of WisconsinCollege of Nursing, Medical University of South CarolinaDepartment of Public Health Services, College of Medicine, Medical University of South CarolinaDepartment of Medicine, Division of General Internal Medicine, Medical College of WisconsinDepartment of Medicine, Division of General Internal Medicine, Medical College of WisconsinHealth Economics Resource Center, VA Palo Alto Healthcare SystemDepartment of Medicine, Division of General Internal Medicine, Medical College of WisconsinAbstract 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.https://doi.org/10.1186/s13063-021-05744-1DiabetesElderlySeniorsOlder adultsEducationBehavioral activation |
| spellingShingle | Leonard E. Egede Tatiana M. Davidson Rebecca G. Knapp Rebekah J. Walker Joni S. Williams Clara E. Dismuke Aprill Z. Dawson 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 Diabetes Elderly Seniors Older adults Education Behavioral activation |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| topic | Diabetes Elderly Seniors Older adults Education Behavioral activation |
| url | https://doi.org/10.1186/s13063-021-05744-1 |
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