BACKGROUND: African Americans suffer more than non-Hispanic whites from type 2 diabetes, but diabetes selfmanagement education (DSME) has been less effective at improving glycemic control for African Americans. Our objective was to determine whether a novel, culturally tailored DSME intervention would result in sustained improvements in glycemic control in low-income African-American patients of public hospital clinics. RESEARCH DESIGN AND METHODS: This randomized controlled trial (n = 211) compared changes in hemoglobin A1c (A1c) at 6, 12, and 18 months between two arms: (1) Lifestyle Improvement through Food and Exercise (LIFE), a culturally tailored, 28-session community-based intervention, focused on diet and physical activity, and (2) a standard of care comparison group receiving two group DSME classes. Cluster-adjusted ANCOVA modeling was used to assess A1c changes from baseline to 6, 12, and 18 months, respectively, between arms. RESULTS: At 6 months, A1c decreased significantly more in the intervention group than the control group (− 0.76 vs − 0.21%, p = 0.03). However, by 12 and 18 months, the difference was no longer significant (12 months − 0.63 intervention vs − 0.45 control, p = 0.52). There was a decrease in A1c over 18 months in both the intervention (β = − 0.026, p = 0.003) and the comparison arm (β = − 0.018, p = 0.048) but no difference in trend (p = 0.472) between arms. The intervention group had greater improvements in nutrition knowledge (11.1 vs 6.0 point change, p = 0.002) and diet quality (4.0 vs − 0.5 point change, p = 0.018) while the comparison group had more participants with improved medication adherence (24% vs 10%, p < 0.05) at 12 months. CONCLUSIONS: The LIFE intervention resulted in improved nutrition knowledge and diet quality and the comparison intervention resulted in improved medication adherence. LIFE participants showed greater A1c reduction than standard of care at 6 months but the difference between groups was no longer significant at 12 and 18 months. NIH TRIAL REGISTRY NUMBER: NCT01901952
Please tell me the day of the week 2: Please tell me the months of the year backward, say December as your first month
MISSED MONTHIf participant finished reciting months but missed one or more, it is incorrect and no prompting is allowed.
STUCKPrompt only with: "what month comes before __________ (last month they said)?"Prompt up to two times; if after 2 prompts participant is frustrated, confused, or taking a long time, mark it incorrect and offer them an exit such as, "that's a tough one, you're doing well… let's try the next question."
WRONG TYPE OF ANSWERIf the participant begins at November, starts forward, or begins spelling, assume they don't understand the question and re-read the instructions once. If the participant is incorrect again, mark it as incorrect but let them finish.The participant can check anywhere (e.g., white board, newspaper, etc.), but cannot ask anyone else in the room.
Objectives
African American and Hispanic elderly are at elevated risk of both depression and cardiovascular disease, relative to non-Hispanic whites. Effective interventions are therefore needed to address depressive symptoms and to reduce these disparities. BRIGHTEN Heart was a behavioral randomized controlled trial to test the efficacy of a virtual team intervention in reducing depressive symptoms in minority elderly as measured by the 9-item Patient Health Questionnaire (PHQ9).
Study design
250 African American and Hispanic adults, age ≥60 years, with comorbid depression and overweight/obesity were randomized. Participants randomized to the Intervention condition received a social work evaluation, team-based electronic consultation, case management, and psychotherapy over a 12 month period. Control participants were enrolled in a membership program that provided health classes and other services to support chronic disease self-management. Blinded research assistants completed assessments at baseline, and 6 and 12 months postrandomization.
Results
The study population was characterized by low socioeconomic status, with 81.4% having a household income of less than $20,000. Although median depression scores were in the mild range, 25% of participants had scores showing moderate to severe depression at baseline. 75% of participants had four or more chronic conditions. Significant demographic and clinical differences were observed between the African American and Hispanic populations.
Conclusions
BRIGHTEN Heart was designed to rigorously test the efficacy of a multi-level intervention to reduce comorbid depressive symptoms and cardiovascular risk in minority elderly. Investigators successfully recruited a cohort well suited to testing the study hypothesis.
Although outcomes were attenuated relative to those obtained in therapist led intervention studies, the results suggest that self-help CBT-I has good potential to serve as a first-line, cost-effective treatment for both primary and comorbid insomnia in older adults.
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