Recruitment and baseline data of the Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study: A randomized trial of a hearing loss intervention for reducing cognitive decline.

INTRODUCTION: Hearing loss is highly prevalent among older adults and independently associated with cognitive decline. The Aging and Cognitive Health Evaluation in Elders (ACHIEVE) study is a multicenter randomized control trial (partially nested within the infrastructure of an observational cohort study, the Atherosclerosis Risk in Communities [ARIC] study) to determine the efficacy of best-practice hearing treatment to reduce cognitive decline over 3 years. The goal of this paper is to describe the recruitment process and baseline results. METHODS: Multiple strategies were used to recruit community-dwelling 70-84-year-old participants with adult-onset hearing loss who were free of substantial cognitive impairment from the parent ARIC study and de novo from the surrounding communities into the trial. Participants completed telephone screening, an in-person hearing, vision, and cognitive screening, and a comprehensive hearing assessment to determine eligibility. RESULTS: Over a 24-month period, 3004 telephone screenings resulted in 2344 in-person hearing, vision, and cognition screenings and 1294 comprehensive hearing screenings. Among 1102 eligible, 977 were randomized into the trial (median age = 76.4 years; 53.5% female; 87.8% White; 53.3% held a Bachelor's degree or higher). Participants recruited through the ARIC study were recruited much earlier and were less likely to report hearing loss interfered with their quality of life relative to participants recruited de novo from the community. Minor differences in baseline hearing or health characteristics were found by recruitment route (i.e., ARIC study or de novo) and by study site. DISCUSSION: The ACHIEVE study successfully completed enrollment over 2 years that met originally projected rates of recruitment. Substantial operational and scientific efficiencies during study startup were achieved through embedding this trial within the infrastructure of a longstanding and well-established observational study. Highlights: The ACHIEVE study tests the effect of hearing intervention on cognitive decline.The study is partially nested within an existing cohort study.Over 2 years, 977 participants recruited and enrolled.Eligibility assessed by telephone and in-person for hearing, vision, and cognitive screening.The ACHIEVE study findings will have significant public health implications.

Loneliness and its predictors among older adults prior to and during the COVID-19 pandemic: cross-sectional and longitudinal survey findings from participants of the Atherosclerosis Risk in Communities (ARIC) Study cohort in the USA.

OBJECTIVES: We aimed to ascertain the prevalence of perceived loneliness among older adults following the onset of the COVID-19 pandemic and to examine factors contributing to the perception of loneliness. DESIGN: Cross-sectional and longitudinal data from the Atherosclerosis Risk in Communities (ARIC) Study cohort. SETTING: The ARIC Study cohort, a prospective cohort that recruited (1987-1989) participants from four distinct communities in the USA. PARTICIPANTS: 2984 ARIC cohort members. PRIMARY AND SECONDARY OUTCOMES: Perceived loneliness assessed using the University of California at Los Angeles (UCLA) UCLA three-item Loneliness Scale telephone interviews conducted May-October 2020 and prior to March 2020. RESULTS: Of the total 5037 participants alive in 2020, 2984 (56.2%) responded to the UCLA three-item questionnaire (mean age 82.6 (SD 4.6) years, 586 (19.6%) black participants, 1081 (36.2%) men), of which 66 (2.2%) reported having had a COVID-19 infection during the observation period. The proportion of participants reporting feeling lonely was 56.3% (n=1680). Among participants with repeat measures of loneliness (n=516), 35.2% (n=182) reported feeling more lonely following pandemic onset. Self-rated health and emotional resilience were strongly associated with self-perceived loneliness. The burden of COVID-19 infections, concern about the pandemic and decreased self-reported physical activity were greater among black as compared with white participants and among those with an educational attainment of less than high school as compared with high school or more. CONCLUSION: Findings from this study document the increase in perceived loneliness among older adults during the COVID-19 pandemic in the USA.

Glucose Patterns in Very Old Adults: A Pilot Study in a Community-Based Population.

Context: Continuous glucose monitoring (CGM) provides nuanced information on glucose patterns, but data in very old adults are scarce. Objective: To evaluate CGM patterns in very old adults. Design: Pilot study. Setting: Participants recruited from one center during visit 7 (2019) of the community-based Atherosclerosis Risk in Communities (ARIC) Study. Participants: We enrolled 27 adults (8 with type 2 diabetes and 19 without diabetes) who wore a CGM sensor (Abbott Libre Pro) for up to 14 days. Clinical and laboratory measures, including hemoglobin A1c (HbA1c), were obtained. Main Outcomes: Mean CGM glucose, standard deviation (SD), coefficient of variation (CV), time-in-range (TIR) 70-180 mg/dL, and hypoglycemia. Results: Mean age was 81 (range 77-91 years) and mean CGM wear time was 13.2 days. In persons without diabetes, there was a wide range of CGM parameters: range of mean glucose, 83.7-124.5 mg/dL, SD 12.2-27.3 mg/dL, CV 14.0%-26.7%, and TIR 71.1%-99.5%. In persons with diabetes, the range of mean CGM glucose was 105.5-223.0 mg/dL, SD, 22.3-86.6 mg/dL, CV 18.2%-38.8%, TIR 38.7%-98.3%. The Pearson's correlation of mean glucose with HbA1c was high overall (0.90); but, for some participants with similar HbA1c, glucose patterns differed substantially. There was a high prevalence of hypoglycemia (glucose <70 or <54 mg/dL) in both persons with and without diabetes. Conclusions: There was high feasibility and acceptability of CGM in very old adults. Low readings on CGM are common, even in nondiabetic older adults; the clinical relevance of these low values is unclear. CGM may provide complementary information to HbA1c in some older adults.

The Effects of Four Doses of Vitamin D Supplements on Falls in Older Adults : A Response-Adaptive, Randomized Clinical Trial.

BACKGROUND: Vitamin D supplementation may prevent falls in older persons, but evidence is inconsistent, possibly because of dosage differences. OBJECTIVE: To compare the effects of 4 doses of vitamin D3 supplements on falls. DESIGN: 2-stage Bayesian, response-adaptive, randomized trial. (ClinicalTrials.gov: NCT02166333). SETTING: 2 community-based research units. PARTICIPANTS: 688 participants, aged 70 years and older, with elevated fall risk and a serum 25-hydroxyvitamin D [25-(OH)D] level of 25 to 72.5 nmol/L. INTERVENTION: 200 (control), 1000, 2000, or 4000 IU of vitamin D3 per day. During the dose-finding stage, participants were randomly assigned to 1 of the 4 vitamin D3 doses, and the best noncontrol dose for preventing falls was determined. After dose finding, participants previously assigned to receive noncontrol doses received the best dose, and new enrollees were randomly assigned to receive 200 IU/d or the best dose. MEASUREMENTS: Time to first fall or death over 2 years (primary outcome). RESULTS: During the dose-finding stage, the primary outcome rates were higher for the 2000- and 4000-IU/d doses than for the 1000-IU/d dose, which was selected as the best dose (posterior probability of being best, 0.90). In the confirmatory stage, event rates were not significantly different between participants with experience receiving the best dose (events and observation time limited to the period they were receiving 1000 IU/d; n = 308) and those randomly assigned to receive 200 IU/d (n = 339) (hazard ratio [HR], 0.94 [95% CI, 0.76 to 1.15]; P = 0.54). Analysis of falls with adverse outcomes suggested greater risk in the experience-with-best-dose group versus the 200-IU/d group (serious fall: HR, 1.87 [CI, 1.03 to 3.41]; fall with hospitalization: HR, 2.48 [CI, 1.13 to 5.46]). LIMITATIONS: The control group received 200 IU of vitamin D3 per day, not a placebo. Dose finding ended before the prespecified thresholds for dose suspension and dose selection were reached. CONCLUSION: In older persons with elevated fall risk and low serum 25-(OH)D levels, vitamin D3 supplementation at doses of 1000 IU/d or higher did not prevent falls compared with 200 IU/d. Several analyses raised safety concerns about vitamin D3 doses of 1000 IU/d or higher. PRIMARY FUNDING SOURCE: National Institute on Aging.

A randomized feasibility pilot trial of hearing treatment for reducing cognitive decline: Results from the Aging and Cognitive Health Evaluation in Elders Pilot Study.

INTRODUCTION: Hearing loss (HL) is prevalent and independently related to cognitive decline and dementia. There has never been a randomized trial to test if HL treatment could reduce cognitive decline in older adults. METHODS: A 40-person (aged 70-84 years) pilot study in Washington County, MD, was conducted. Participants were randomized 1:1 to a best practices hearing or successful aging intervention and followed for 6 months. clinicaltrials.gov Identifier: NCT02412254. RESULTS: The Aging and Cognitive Health Evaluation in Elders Pilot (ACHIEVE-P) Study demonstrated feasibility in recruitment, retention, and implementation of interventions with no treatment-related adverse events. A clear efficacy signal of the hearing intervention was observed in perceived hearing handicap (mean of 0.11 to -1.29 standard deviation [SD] units; lower scores better) and memory (mean of -0.10 SD to 0.38 SD). DISCUSSION: ACHIEVE-P sets the stage for the full-scale ACHIEVE trial (N = 850, recruitment beginning November 2017), the first randomized trial to determine efficacy of a best practices hearing (vs. successful aging) intervention on reducing cognitive decline in older adults with HL.