PMID- 34749788 OWN - NLM STAT- MEDLINE DCOM- 20211110 LR - 20231108 IS - 1745-6215 (Electronic) IS - 1745-6215 (Linking) VI - 22 IP - 1 DP - 2021 Nov 8 TI - 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. PG - 787 LID - 10.1186/s13063-021-05744-1 [doi] LID - 787 AB - 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. CI - (c) 2021. The Author(s). FAU - Egede, Leonard E AU - Egede LE AUID- ORCID: 0000-0003-1546-1515 AD - Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA. legede@mcw.edu. AD - Center for Advancing Population Science, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA. legede@mcw.edu. FAU - Davidson, Tatiana M AU - Davidson TM AD - College of Nursing, Medical University of South Carolina, 99 Jonathan Lucas St, MSC 160, Charleston, SC, 29425, USA. FAU - Knapp, Rebecca G AU - Knapp RG AD - Department of Public Health Services, College of Medicine, Medical University of South Carolina, 135 Cannon St., Charleston, SC, 29425, USA. FAU - Walker, Rebekah J AU - Walker RJ AD - Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA. AD - Center for Advancing Population Science, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA. FAU - Williams, Joni S AU - Williams JS AD - Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA. AD - Center for Advancing Population Science, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA. FAU - Dismuke, Clara E AU - Dismuke CE AD - Health Economics Resource Center, VA Palo Alto Healthcare System, 795 Willow Road (152 MPD), Menlo Park, CA, 94025, USA. FAU - Dawson, Aprill Z AU - Dawson AZ AD - Department of Medicine, Division of General Internal Medicine, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA. AD - Center for Advancing Population Science, Medical College of Wisconsin, 8701 Watertown Plank Rd, Milwaukee, WI, 53226, USA. LA - eng SI - ClinicalTrials.gov/NCT04203147 GR - K24DK093699/DK/NIDDK NIH HHS/United States GR - R01DK118038/DK/NIDDK NIH HHS/United States GR - R01MD013826/MD/NIMHD NIH HHS/United States GR - R01 DK120861/DK/NIDDK NIH HHS/United States GR - R01 MD013826/MD/NIMHD NIH HHS/United States GR - R01DK120861/DK/NIDDK NIH HHS/United States GR - R01 DK118038/DK/NIDDK NIH HHS/United States PT - Clinical Trial Protocol PT - Journal Article DEP - 20211108 PL - England TA - Trials JT - Trials JID - 101263253 SB - IM MH - Black or African American MH - Aged MH - *Diabetes Mellitus, Type 2/diagnosis/therapy MH - Humans MH - Poverty MH - Prospective Studies MH - Randomized Controlled Trials as Topic MH - Telephone PMC - PMC8574935 OTO - NOTNLM OT - Behavioral activation OT - Diabetes OT - Education OT - Elderly OT - Older adults OT - Seniors OT - Skills training COIS- The authors declare that they have no competing interests. EDAT- 2021/11/10 06:00 MHDA- 2021/11/11 06:00 PMCR- 2021/11/08 CRDT- 2021/11/09 05:43 PHST- 2021/06/10 00:00 [received] PHST- 2021/10/20 00:00 [accepted] PHST- 2021/11/09 05:43 [entrez] PHST- 2021/11/10 06:00 [pubmed] PHST- 2021/11/11 06:00 [medline] PHST- 2021/11/08 00:00 [pmc-release] AID - 10.1186/s13063-021-05744-1 [pii] AID - 5744 [pii] AID - 10.1186/s13063-021-05744-1 [doi] PST - epublish SO - Trials. 2021 Nov 8;22(1):787. doi: 10.1186/s13063-021-05744-1.