The Impact of an Educational Video on Clinical Trial Enrollment and Knowledge in Ethnic Minorities: A Randomized Control Trial.

Introduction: Innovative methods to increase awareness about clinical trials and address barriers associated with low participation among racial/ethnic minorities are desperately needed. African Americans comprise 5% of all clinical trial participants, and Hispanics make up 1%. Use of multimedia educational material has shown promise as an effective strategy to increase minority clinical trial enrollment. However, this approach has not been broadly implemented. We tested the effect of a video educational program on clinical trial knowledge and enrollment in a sample of oncology outpatients. Methods: A randomized controlled trial was conducted with 63 oncology patients without previous history of clinical trial participation. Participants were randomly assigned to the intervention, to watch a clinical trial educational video in the office, or to the control group which did not receive in-office education. The Clinical Trial Knowledge survey was administered before the intervention and 1 week after the intervention. Participation in clinical trials was assessed 1-year post study participation. Results for white participants and ethnic minorities were compared. Ethnicity was self-reported through the electronic health record and confirmed by self-reporting on questionnaire. Results: Sixty-three participants were recruited in this study. At 1-year follow-up, 3 participants enrolled in clinical trials in the study group which had received office-based video intervention and 2 participants enrolled in the control group (Z = 0.39, p = 0.69). These results were not statistically significant. Impact of the intervention by ethnicity could not be assessed due to low total clinical trial enrollment. The video intervention did not change knowledge, attitudes, or barriers as measured by the Clinical Trial Knowledge Survey. Minority participants did report significantly more negative beliefs and barriers to participation than white participants. Conclusions: Increasing awareness and knowledge about clinical trials in underrepresented communities is an important step to providing opportunities for participation. Future studies should focus on how to address the negative expectations of clinical trials and the greater information needs in minority populations. Tailored or personalized messaging may address negative perceptions of clinical trial participation.

A Community-Based Collaborative Care Model to Improve Functional Health in Underserved Community-Dwelling Older Adults.

OBJECTIVE: Examine the effects of a 6-month health multidimensional intervention on physical function, bone density, and mood in a diverse sample of community-dwelling older adults at risk for frailty and excess disability. METHOD: A quasi-experimental, pre- post-program design was implemented. Adults aged 55 years and older ( n = 337, 60% African American) participated in the intervention and received assessments at baseline, 6 months, and 12 months. RESULTS: Physical function was maintained during the intervention for both African American and White elders but declined at 12 months for both groups ( p < .0001). Symptoms of depression improved during the intervention ( M = 0.65 ± 0.07, M = 0.15 ± 0.04, M = 0.68 ± 0.07, p < .001, respectively) but worsened at 12 months ( M = 0.68 ± 0.07, p < .001). Bone density scores remained stable from baseline (distal: -1.62 ± 1.17, proximal: -2.73 ± 1.85) to 12 months (distal: -1.72 ± 1.21, proximal: -3.11 ± 1.85, ps > .05) for both groups. DISCUSSION: Program findings may serve as a basis for the development of a randomized, controlled study to provide empirical evidence of intervention efficacy. Such findings may help inform the development of community-based programs to identify vulnerable older adults and provide vital preventative care to decrease frailty and excess disability.

Community Experiences and Perceptions of Clinical and Translational Research and Researchers.

BACKGROUND: Engaging communities in research is increasingly recognized as critical to translation of research into improved health outcomes. Our objective was to understand community stakeholders' perspectives on researchers, academic institutions, and how community is valued in research. METHODS: A 45-item survey assessing experiences and perceptions of research (trust, community value, equity, researcher preparedness, and indicators of successful engagement) was distributed to 226 community members involved in health research with academic institutions. RESULTS: Of the 109 respondents, 60% were racial/ethnic minorities and 78% were women, representing a range of community organizations, faith-based organizations, and public health agencies. Most (57%) reported current involvement with a Clinical and Translational Science Award (CTSA). Only 25% viewed researchers as well-prepared to engage communities and few (13%) reported that resources were available and adequate to support community involvement. Most community stakeholders (66%) were compensated for their involvement in research, but only 40% perceived compensation to be appropriate. Trust of research and perceptions that researchers value community were more positive among those who perceived their compensation as appropriate (P = .001). CONCLUSIONS: Appropriate compensation and resources to support community involvement in research may improve perceptions of trust and value in academic-community partnerships. Strategies are needed to increase researcher preparedness to engage with communities.

Exploring the "Obesity Paradox" as a Correlate of Cognitive and Physical Function in Community-dwelling Black and White Older Adults.

Objective: The obesity paradox has been documented in aged populations, yet it remains unclear if this paradox persists for physical and cognitive outcomes in community-dwelling older adult populations. Our study examines associations between body mass index (BMI) classification, cognitive function, and physical function. We also investigate whether these associations are modified by race or age. Design: Cross-sectional study. Setting: Senior residential sites and community centers in Saint Louis, Missouri. Participants: Study participants included 331 adults, aged >55 years. Age was stratified into young-old (aged 55-74 years) and older (aged ≥75 years). Outcome Measures: Physical function was measured using the mini-Physical Performance Test (mini-PPT) and grip strength. Cognitive function was assessed with the Short Blessed Test (SBT) and the Trail Making Tests (TMT-A and TMT-B) performance. Results: Older adults who were obese had significantly better cognitive flexibility (TMT-B) performance than normal weight older adults (P=.02), and this association was not influenced by age or race. Adiposity was not associated with psychomotor speed (TMT-A), general cognition (SBT), or measures of physical function (Ps>.05). Conclusion: In a diverse sample of community-dwelling older adults, we found partial support for the controversial obesity paradox. Our results suggest excess adiposity may be protective for executive function processes. Future research is needed to examine the underlying physiological processes linking adiposity to executive function in older adults.

Examining the Influence of Measures of Adiposity on Cognitive Function in Middle Age and Older African Americans.

The objectives of the study were to examine whether measures of total obesity (body mass index [BMI]) and central obesity (waist circumference [WC] and waist-to-hip ratio [WHR]) are associated with cognitive function in African Americans, and whether sex moderates these associations. A sample of 194 African Americans, with a mean age of 58.97 years, completed a battery of cognitive tests and a self-reported health questionnaire. Height, weight, waist and hip circumference, and blood pressure were assessed. Linear regression analyses were run. Results suggested lower performance on measures of verbal fluency and complex attention/cognitive flexibility was accounted for by higher levels of central adiposity. Among men, higher WHR was more strongly related to complex attention/cognitive flexibility performance, but for women, WC was a salient predictor. Higher BMI was associated with poorer verbal memory performance among men, but poorer nonverbal memory performance among women. Findings suggest a need for healthy lifestyle interventions for African Americans to maintain healthy weight and cognitive function.

Predictors of Retest Effects in a Longitudinal Study of Cognitive Aging in a Diverse Community-Based Sample.

Better performance due to repeated testing can bias long-term trajectories of cognitive aging and correlates of change. We examined whether retest effects differ as a function of individual differences pertinent to cognitive aging: race/ethnicity, age, sex, language, years of education, literacy, and dementia risk factors including apolipoprotein E ε4 status, baseline cognitive performance, and cardiovascular risk. We used data from the Washington Heights-Inwood Columbia Aging Project, a community-based cohort of older adults (n=4073). We modeled cognitive change and retest effects in summary factors for general cognitive performance, memory, executive functioning, and language using multilevel models. Retest effects were parameterized in two ways, as improvement between the first and subsequent testings, and as the square root of the number of prior testings. We evaluated whether the retest effect differed by individual characteristics. The mean retest effect for general cognitive performance was 0.60 standard deviations (95% confidence interval [0.46, 0.74]), and was similar for memory, executive functioning, and language. Retest effects were greater for participants in the lowest quartile of cognitive performance (many of whom met criteria for dementia based on a study algorithm), consistent with regression to the mean. Retest did not differ by other characteristics. Retest effects are large in this community-based sample, but do not vary by demographic or dementia-related characteristics. Differential retest effects may not limit the generalizability of inferences across different groups in longitudinal research.

Relationship Between Type 2 Diabetes Mellitus and Cognitive Change in a Multiethnic Elderly Cohort.

OBJECTIVES: To examine the association between diabetes mellitus and cognitive functioning at baseline and cognitive change over time in a large, ethnically diverse sample of older adults. DESIGN: Prospective cohort study. SETTING: Washington Heights-Inwood Columbia Aging Project, a community-based, prospective study of risk factors for dementia in northern Manhattan, New York City. PARTICIPANTS: Hispanic, non-Hispanic black, and non-Hispanic white men and women aged 65 and older without dementia at baseline (N = 1,493). MEASUREMENTS: Participants underwent baseline and follow-up cognitive and health assessments approximately every 18 months. Generalized estimating equations were used to examine the longitudinal association between diabetes mellitus and cognition. RESULTS: Diabetes mellitus was associated with poorer baseline cognitive performance in memory, language, processing speed and executive functioning, and visuospatial abilities. After adjusting for age, education, sex, race and ethnicity, and apolipoprotein-ε4, participants with diabetes mellitus performed significantly worse at baseline than those without in language and visuospatial abilities. There were no differences between those with and without diabetes mellitus in terms of rate of cognitive change over a mean follow-up time of 6 years. CONCLUSION: The rate of cognitive change in elderly persons with and without diabetes mellitus is similar, although cognitive performance is poorer in persons with diabetes mellitus. These findings suggest that cognitive changes may occur early during the diabetes mellitus process and highlight the need for studies to follow participants beginning at least in midlife, before the typical later-life onset of dementia.

Assessing the effectiveness of pharmacist-directed medication therapy management in improving diabetes outcomes in patients with poorly controlled diabetes.

PURPOSE: The purpose of this study was to compare medication adherence rates and type 2 diabetes mellitus (T2DM) health outcomes in a sample of underserved patients with suboptimally controlled T2DM (A1C >7%) who had received pharmacist-directed medication therapy management (MTM) to those who had not received MTM. METHODS: A retrospective review of 100 patient records was conducted. For the MTM group, a pharmacist engaged patients in patient-centered services to optimize therapeutic outcomes. Non-MTM patients received usual care. Outcomes were A1C, medication adherence, blood pressure, lipids, and creatinine. Group comparisons on clinical outcomes were analyzed before and after matching MTM and non-MTM patients on demographic characteristics. RESULTS: Before matching, the MTM group had a higher rate of medication adherence than the non-MTM group. The A1C levels were lower in the MTM group compared to the non-MTM group. Similarly, low-density lipoprotein (LDL) cholesterol was lower in the MTM group compared to the non-MTM group. After matching, medication adherence rate remained higher in the MTM group than the non-MTM group. Similarly, A1C levels remained lower in the MTM group than the non-MTM group. CONCLUSIONS: There is a paucity of research focused on behavioral interventions for improving health outcomes in underserved communities. Our results advance the existing literature by demonstrating a positive association between pharmacist-directed MTM, medication adherence, and glycemic control in a sample of underserved patients with suboptimally controlled T2DM. A prospective pharmacy intervention and examination of long-term effects of MTM on medication adherence and T2DM health outcomes in this population is warranted.

Associations between Markers of Glucose and Insulin Function and Cognitive Function in Healthy African American Elders.

BACKGROUND: Glucose and insulin are important moderators of cognitive function. African Americans have poorer glycemic control across the glycemic spectrum and are at increased risk for type 2 diabetes and poor cognitive health. It is unclear which glucoregulatory markers predict cognitive function in this at-risk population. The purpose of this study was to examine the association between cognitive function and common markers of glucoregulation in non-diabetic African Americans elders. METHODS: Thirty-four, community-dwelling African Americans, aged 50-75 years completed cognitive testing and blood collection as part of a health screening assessment. Cognitive outcomes were composite scores derived from neuropsychological tests of executive function and verbal memory. Linear regression was used to examine relationships between cognitive composite scores and fasting blood levels of glucose, insulin, and hemoglobin A1C, with adjustments for age, education, body mass index, and antihypertensive medication use. RESULTS: Fasting plasma glucose was negatively associated with executive function (ß=-0.41, p=0.03). There was a trend of an association between fasting plasma glucose and verbal memory (ß=-0.34, p=0.06). Fasting insulin and hemoglobin A1c were not associated with cognitive function. CONCLUSION: High non-diabetic fasting glucose levels were associated with poorer executive function and verbal memory. These results provide preliminary support for proactive glucose control in older African Americans even before glycemic criteria for type 2 diabetes are met. Our findings suggests that high-normal FPG levels may represent an early red-flag to signify increased risk of cognitive impairment or decline.

Adverse vascular risk is related to cognitive decline in older adults.

BACKGROUND: Cardiovascular disease (CVD) and related risk factors are associated with Alzheimer's disease (AD). This association is less well-defined in normal cognition (NC) or prodromal AD (mild cognitive impairment, MCI). OBJECTIVE: Cross-sectionally and longitudinally relate a vascular risk index to cognitive outcomes among elders free of clinical dementia. METHODS: 3,117 MCI (74 ± 8 years, 56% female) and 6,603 NC participants (72 ± 8 years, 68% female) were drawn from the National Alzheimer's Coordinating Center. A composite measure of vascular risk was defined using the Framingham Stroke Risk Profile (FSRP) score (i.e., age, systolic blood pressure, anti-hypertensive medication, diabetes, cigarette smoking, CVD history, atrial fibrillation). Ordinary linear regressions and generalized linear mixed models related baseline FSRP to cross-sectional and longitudinal cognitive outcomes, separately for NC and MCI, adjusting for age, gender, race, education, and follow-up time (in longitudinal models). RESULTS: In NC participants, increasing FSRP was related to worse baseline global cognition, information processing speed, and sequencing abilities (p-values <0.0001) and a worse longitudinal trajectory on all cognitive measures (p-values <0.0001). In MCI, increasing FSRP correlated with worse longitudinal delayed memory (p = 0.004). In secondary models using an age-excluded FSRP score, associations persisted in NC participants for global cognition, naming, information processing speed, and sequencing abilities. CONCLUSIONS: An adverse vascular risk profile is associated with worse cognitive trajectory, especially global cognition, naming, and information processing speed, among NC elders. Future studies are needed to understand how effective management of CVD and related risk factors can modify cognitive decline to identify the ideal timeframe for primary prevention implementation.

The role of early-life educational quality and literacy in explaining racial disparities in cognition in late life.

OBJECTIVES: Racial disparities in late-life cognition persist even after accounting for educational attainment. We examined whether early-life educational quality and literacy in later life help explain these disparities. METHOD: We used longitudinal data from the Washington Heights-Inwood Columbia Aging Project (WHICAP). Educational quality (percent white students; urban/rural school; combined grades in classroom) was operationalized using canonical correlation analysis. Late-life literacy (reading comprehension and ability, writing) was operationalized using confirmatory factor analysis. We examined whether these factors attenuated race-related differences in late-life cognition. RESULTS: The sample consisted of 1,679 U.S.-born, non-Hispanic, community-living adults aged 65-102 (71% black, 29% white; 70% women). Accounting for educational quality and literacy reduced disparities by 29% for general cognitive functioning, 26% for memory, and 32% for executive functioning but did not predict differences in rate of cognitive change. DISCUSSION: Early-life educational quality and literacy in late life explain a substantial portion of race-related disparities in late-life cognitive function.

Association of vascular risk factors with cognition in a multiethnic sample.

OBJECTIVES: To examine the relationship between cardiovascular risk factors (CVRFs) and cognitive performance in a multiethnic sample of older adults. METHOD: We used longitudinal data from the Washington Heights-Inwood Columbia Aging Project. A composite score including smoking, stroke, heart disease, diabetes, hypertension, and central obesity represented CVRFs. Multiple group parallel process multivariate random effects regression models were used to model cognitive functioning and examine the contribution of CVRFs to baseline performance and change in general cognitive processing, memory, and executive functioning. RESULTS: Presence of each CVRF was associated with a 0.1 SD lower score in general cognitive processing, memory, and executive functioning in black and Hispanic participants relative to whites. Baseline CVRFs were associated with poorer baseline cognitive performances among black women and Hispanic men. CVRF increase was related to baseline cognitive performance only among Hispanics. CVRFs were not related to cognitive decline. After adjustment for medications, CVRFs were not associated with cognition in Hispanic participants. DISCUSSION: CVRFs are associated with poorer cognitive functioning, but not cognitive decline, among minority older adults. These relationships vary by gender and medication use. Consideration of unique racial, ethnic, and cultural factors is needed when examining relationships between CVRFs and cognition.

The Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-Plus): an expansion of the ADAS-Cog to improve responsiveness in MCI.

BACKGROUND: The Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) is widely used in AD, but may be less responsive to change when used in people with mild cognitive impairment (MCI). METHODS: Participants from the Alzheimer's Disease Neuroimaging Initiative were administered a neuropsychological battery and 1.5 T MRI scans over 2-3 years. Informants were queried regarding functional impairments. Some participants had lumbar punctures to obtain cerebrospinal fluid (CSF). We added executive functioning (EF) and functional ability (FA) items to the ADAS-Cog to generate candidate augmented measures. We calibrated these candidates using baseline data (n = 811) and selected the best candidate that added EF items alone and that added EF and FA items. We selected candidates based on their responsiveness over three years in a training sample of participants with MCI (n = 160). We compared traditional ADAS-Cog scores with the two candidates based on their responsiveness in a validation sample of participants with MCI (n = 234), ability to predict conversion to dementia (n = 394), strength of association with baseline MRI (n = 394) and CSF biomarkers (n = 193). RESULTS: The selected EF candidate added category fluency (ADAS Plus EF), and the selected EF and FA candidate added category fluency, Digit Symbol, Trail Making, and five items from the Functional Assessment Questionnaire (ADAS Plus EF&FA). The ADAS Plus EF& FA performed as well as or better than traditional ADAS-Cog scores. CONCLUSION: Adding EF and FA items to the ADAS-Cog may improve responsiveness among people with MCI without impairing validity.

High-intensity physical activity modulates diet effects on cerebrospinal amyloid-ß levels in normal aging and mild cognitive impairment.

We previously showed that amyloid-ß 1-42 (Aß(42)) levels in cerebrospinal fluid (CSF) were markedly altered in response to a 4-week dietary intervention in normal aging and mild cognitive impairment (MCI). Here, we re-examined the data to assess whether diet-induced effects on CSF Aß(42) were modulated by high intensity physical activity (hi-PA). Normal older adults (n = 18, mean age = 68.6 ± 7.4 y) and adults with amnestic MCI (n = 23, mean age = 68.0 ± 6.5 y) received a low saturated fat/low glycemic index (LOW) diet or a high saturated fat/high glycemic index (HIGH) diet, and CSF levels of Aß(42), tau, and IL-8 were measured at baseline and week 4. Pre-study activity levels were assessed using a 7-d questionnaire, and weekly duration of hi-PA was quantified. At baseline, increased hi-PA in normals predicted lower CSF levels of tau (r = -0.54, p = 0.020) and IL-8 (r = -0.70, p = 0.025). Diet-induced effects on CSF Aß(42) during the intervention study were modulated by hi-PA, and the nature of this effect differed for normals and MCI (ANOVA, p = 0.039). That is, for normal adults, increased hi-PA attenuated the effects of the HIGH diet on CSF Aß(42) whereas in MCI, increased hi-PA potentiated the effects of the LOW diet. Our results suggest that normal adults who engage in hi-PA are less vulnerable to the pathological effects of an unhealthy diet, while in MCI, the benefit of a healthy diet on Aß modulation is greatest when paired with hi-PA. Exercise may thus interact with diet to alter pathological processes that ultimately modify risk of Alzheimer's disease.