The virtual cognitive health (VC Health) study: design, recruitment, and baseline characteristics of a fully remote single-arm pre-post study to prevent or delay cognitive impairment in older adults (Preprint)
BACKGROUND A growing body of evidence supports the use of lifestyle interventions for preventing or delaying the onset of Alzheimer’s disease (AD) and other forms of dementia in at-risk individuals. The development of virtually delivered programs would increase the scalability and reach of these interventions, but requires validation to ensure similar efficacy to brick and mortar options. OBJECTIVE The aims of this study are to describe the study design, recruitment process, and baseline participant characteristics of the sample in the virtual cognitive health (VC Health) study. Future analyses will assess the impact of the remotely delivered lifestyle intervention on (1) cognitive function, (2) depression and anxiety, and (3) various lifestyle behaviors, including diet, exercise, and sleep in a cohort of older adults with subjective memory decline. Additional analyses will explore feasibility outcomes, as well as the participants’ engagement patterns with the program. METHODS Older adults (age 60-75) with subjective memory decline as measured by the Subjective Cognitive Decline (SCD-9) questionnaire, and who reported feeling worried about their memory decline, were eligible to participate in this single-arm pre-post study. All participants enrolled in the year-long virtual intervention, which consists of health coach-guided lifestyle change for improving diet, exercise, sleep, stress, and cognition. All components of this study were conducted virtually, including the collection of data and the administration of the intervention. Participants were assessed at baseline, 12 weeks, 24 weeks, and 52 weeks with online surveys and the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) test. Intention-to-treat analysis will be conducted on all outcomes. RESULTS A total of 85 participants enrolled in the intervention and 82 are included in the study sample (3 participants withdrew). The study cohort is 74% female, 88% Caucasian, 78% overweight or obese, and 67% have at least a college degree. The average baseline RBANS score was 95.9±11.1, which is within age-adjusted norms. The average SCD-9 score was 6.0±2.0, indicating minor subjective cognitive impairment at the beginning of the study. Average baseline Generalized Anxiety Disorder (GAD-7) scores were 6.2±4.5 and Patient Health Questionnaire (PHQ-9) scores were 8.5±4.9, indicating mild levels of anxiety and depression at baseline. CONCLUSIONS Virtually delivered lifestyle interventions may represent a scalable solution for the prevention or delay of AD. The results of this study will provide the first evidence for the efficacy of a fully remote intervention and lay the groundwork for future investigations. CLINICALTRIAL NCT02969460