This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.There is an unmet need for effective, efficient and economical methods for conducting AD prevention trials. Traditional in-person visits to clinical assessment sites are time consuming and costly and may exclude certain constituencies from participation, such as those who are older, or are less mobile or with significant medical illnesses. These may be the very people who are at greatest risk for cognitive decline, as well as those without financial resources for services such as transportation to a study site. Furthermore, prevention trials require long observation periods and these same issues of health, resources, and transportation may cause significant drop out. These obstacles increase expense of clinical trials as they require large sample sizes, costly clinical staff and long observation periods. Thus, home-based assessments may lead to more representative recruitment of those most at risk for decline, better retention and reduced study costs. In previous work, the use of mail-in and phone assessments was examined as possible methods for assessment.This is a randomized study of 600 subjects, comparing three methods of test administration and data collection (N = 200/method). Each enrolled subject will have an in-person (Standard) assessment (in the clinic or at home) prior to baseline. All eligible subjects will be randomly assigned to an assessment method and to a frequency of assessment. Based on an algorithm using data from the in-person evaluation, participants will be classified as either non-demented or AL-MCI and randomization will be done with stratification for this classification. All domains (i.e., cognitive performance, self-related cognitive complaint, functioning in daily life, affective symptoms, global change, quality of life and resource use) will be assessed in each method at each visit. The total time for the at-home assessments (cognitive performance battery plus the brief questionnaires for the other domains) will be approximately 45 minutes. In addition, all subjects will be provided with a multi-vitamin to be taken twice a day, and a measure of medication adherence will be collected for each assessment method. Based on existing data, a predefined score on a specific cognitive measure will be used to identify significant impairment that will 'trigger' an in-person assessment. The in-person assessment will provide the Standard for assessing change and diagnostic categorization of normal, amnestic MCI (single or multiple domains), non-amnestic MCI (single or multiple domain) impaired not MCI, or dementia (i.e., specifically Alzheimer's Disease or another dementia). We estimate that 12% of the study population will trigger over the 4 years of the study and will progress to a more impaired diagnostic category. In addition, a random sample of non-triggered cases (25%) will be selected for an in-person re-assessment during the 4 years of the protocol as a comparison for the trigger group. At the end of the 4-year study period all subjects will undergo an in-person evaluation.N.B.: This is a prevention instrumentation trial and we expect that most visits will take place in subjects' homes. We may require access to GCRC for initial visits and 'trigger'/discontinuation visits.
| Goldman, Noreen; Glei, Dana A; Weinstein, Maxine (2018) Declining mental health among disadvantaged Americans. Proc Natl Acad Sci U S A 115:7290-7295 |
| Nersesian, Paula V; Han, Hae-Ra; Yenokyan, Gayane et al. (2018) Loneliness in middle age and biomarkers of systemic inflammation: Findings from Midlife in the United States. Soc Sci Med 209:174-181 |
| Glei, Dana A; Goldman, Noreen; Ryff, Carol D et al. (2018) Physical Function in U.S. Older Adults Compared With Other Populations: A Multinational Study. J Aging Health :898264318759378 |
| Stephan, Yannick; Sutin, Angelina R; Bayard, Sophie et al. (2018) Personality and sleep quality: Evidence from four prospective studies. Health Psychol 37:271-281 |
| Magidson, Jessica F; Robustelli, Briana L; Seitz-Brown, C J et al. (2017) Activity enjoyment, not frequency, is associated with alcohol-related problems and heavy episodic drinking. Psychol Addict Behav 31:73-78 |
| Boylan, Jennifer Morozink; Robert, Stephanie A (2017) Neighborhood SES is particularly important to the cardiovascular health of low SES individuals. Soc Sci Med 188:60-68 |
| Liebzeit, Daniel; Phelan, Cynthia; Moon, Chooza et al. (2017) Rest-Activity Patterns in Older Adults with Heart Failure and Healthy Older Adults. J Aging Phys Act 25:116-122 |
| Chirinos, Diana A; Murdock, Kyle W; LeRoy, Angie S et al. (2017) Depressive symptom profiles, cardio-metabolic risk and inflammation: Results from the MIDUS study. Psychoneuroendocrinology 82:17-25 |
| Robinette, Jennifer W; Charles, Susan T; Gruenewald, Tara L (2017) Neighborhood Socioeconomic Status and Health: A Longitudinal Analysis. J Community Health 42:865-871 |
| Sloan, Richard P; Schwarz, Emilie; McKinley, Paula S et al. (2017) Vagally-mediated heart rate variability and indices of well-being: Results of a nationally representative study. Health Psychol 36:73-81 |
Showing the most recent 10 out of 128 publications
