Chelsea

Researchers are evaluating the effects of atorvastatin 40 mg compared to a placebo in older adults aged 75 years and above who live in the community without cardiovascular disease, dementia, or significant disability. This Phase 4 study aims to determine if statins can reduce death, dementia, persistent disability, mild cognitive impairment, and cardiovascular events. The study involves about 20,000 participants across roughly 100 US sites, including both VA and non-VA locations, with inclusion of English or Spanish speakers. Participants will be randomly assigned to receive either atorvastatin 40 mg daily or a matching placebo. The study drug will be mailed directly to participants every 90 days starting immediately after randomization and continuing as long as the participant remains on the study drug. Enrollment and follow-up may include in-person visits or telehealth options. Baseline assessments include physical function tests, cognitive and physical function phone screens annually, and blood samples for lipid panels and biorepository specimens. Lipid testing is repeated at 3 months in a subset of participants. During the study, researchers will collect data through phone assessments, electronic health records, Medicare records, and the National Death Index to monitor cognitive and physical function, cardiovascular events, and other outcomes. Participants will be followed for up to 5 years, with an estimated median follow-up of 3.8 years. Safety and adherence will be supported by centralized recruitment, retention efforts, and direct mailing of study medication, with ongoing monitoring for dementia diagnosis, disability, and cardiovascular events.

This research aims to support the physical and mental health of Veterans living with heart failure by enhancing their disease self-management and coping skills at home. The study evaluates a culturally sensitive, telephone-based, tailored problem-solving intervention designed to improve health outcomes for these Veterans. The research includes a single-group, repeated measures design with a goal to assess recruitment feasibility, program acceptability, effectiveness on health outcomes, and sustainability of benefits over time. Participants will engage in a 12-week telehealth program called Care-HF, which involves eight telephone sessions with a registered nurse. During these sessions, Veterans learn a 5-step problem-solving process based on the Theory of Social Problem-Solving to manage heart failure-related challenges. This intervention emphasizes developing a positive approach to problems and using rational problem-solving strategies to support better physical and mental health. Veterans will complete baseline surveys and follow-up assessments at 3, 6, 12, and 18 months after the intervention. These assessments include evaluations of heart failure self-care, symptoms, depression, anxiety, quality of life, stress, resilience, coping, and healthcare use. Data is collected by trained research staff via telephone to monitor the program's effects and participant progress throughout the study period.