This study will assess the psychosocial and behavioral impacts of receiving Alzheimer's disease genetic risk assessment incorporating APOE genotypes among Latinos in northern Manhattan. The investigators will conduct a longitudinal, community-based study with a mixed methods design. Participants will be randomized to learn about their lifetime risk of late-onset Alzheimer's disease (AD) based either on (a) Latino ethnicity and family history alone (genotype nondisclosure group), or (b) the same factors plus APOE genotype (genotype disclosure group). Responses will be evaluated at 6 weeks, 9 months, and 15 months after risk assessment. In the quantitative component of the study, the investigators will assess psychosocial outcomes, memory test performance, and health-related behaviors. In the qualitative component of the study, the investigators will investigate the lived experience of receiving personal AD risk information, using a stress and coping theoretical framework.
Apolipoprotein E (APOE) is the strongest genetic predictor of risk for late-onset Alzheimer's disease (AD). Given the high level of interest in genetic testing, the demand for predictive testing for APOE will surely increase. Improved understanding of the impacts of testing, sources of variability in response, and inclusion of diverse samples are critical for informing methods to promote safe and effective disclosure of AD genetic risk information. As with other diseases, previous research on AD, a devastating and incurable illness, has found little significant or sustained distress in response to genetic susceptibility testing for APOE, even among persons who learn they are at elevated risk. These surprising findings, which run counter to the experience of many clinicians, may be related to limitations in the methods of previous studies. Most previous studies primarily enrolled well-educated Caucasians with a family history, who were strongly motivated to pursue genetic risk information. Further, most studies assessed impacts primarily through standardized measures of depression and anxiety, which may not capture the kinds of distress experienced or coping strategies that might blunt or mask distress. Qualitative research shows that receipt of genetic information can have important psychosocial effects not well captured through standardized measures. Also, in one study, people with a high-risk gene test for APOE performed worse on memory tests if they were informed about the results than if they were not informed, suggesting that other impact measures are needed. Another important limitation of prior work is that it has lacked representation of ethnic minority groups. Latinos are the second largest U.S. ethnic group, comprising about 18% of the population, yet no previous study has investigated the impacts of receiving AD genetic risk information among Latinos. While AD incidence rates may vary among Latino subgroups, data from the Washington Heights-Inwood Columbia Aging Project (WHICAP), a study in northern Manhattan, indicate that they are about twice as high among Caribbean Hispanics (primarily Dominicans) as among persons of European ancestry. In this study, the investigators will improve understanding of the impacts of receiving personal AD genetic risk information and the factors that influence adjustment to such information among Latinos who live in the same communities studied in WHICAP.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Enrollment
374
Information about risk of Alzheimer's disease will be given to participants based on their APOE genotypes, in addition to Latino ethnicity and family history.
Columbia University Irving Medical Center
New York, New York, United States
Impact of Genetic Testing in AD (IGT-AD)
16-item scale that assesses the impact of test result disclosure across both distress and positive domains. The scale will be modified to anchor it to "risk assessment" rather than genetic test results to enable it to be used in both disclosure groups. Each item scored 0 (never), 1 (rarely) 3 (sometimes) 5 (often). Values are summed; higher total indicates worse outcome (greater adverse impact). Scale range: 0-80.
Time frame: 6 weeks after risk evaluation
Impact of Genetic Testing in AD (IGT-AD)
16-item scale that assesses the impact of test result disclosure across both distress and positive domains. The scale will be modified to anchor it to "risk assessment" rather than genetic test results to enable it to be used in both disclosure groups. Each item scored 0 (never), 1 (rarely) 3 (sometimes) 5 (often). Values are summed; higher total indicates worse outcome (greater adverse impact). Scale range: 0-80.
Time frame: 9 months after risk evaluation
Impact of Genetic Testing in AD (IGT-AD)
16-item scale that assesses the impact of test result disclosure across both distress and positive domains. The scale will be modified to anchor it to "risk assessment" rather than genetic test results to enable it to be used in both disclosure groups. Each item scored 0 (never), 1 (rarely) 3 (sometimes) 5 (often). Values are summed; higher total indicates worse outcome (greater adverse impact). Scale range: 0-80.
Time frame: 15 months after risk evaluation
Impact of Event Scale-Revised
22-item scale to assess subjective distress caused by traumatic events. Each item scored on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscales can be calculated for Intrusion, Avoidance, and Hyperarousal. The authors recommend using means instead of summed scores; higher mean score indicates worse outcome (greater impact). Scale range: 0-4.
Time frame: 6 weeks after risk evaluation
Impact of Event Scale-Revised
22-item scale to assess subjective distress caused by traumatic events. Each item scored on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscales can be calculated for Intrusion, Avoidance, and Hyperarousal. The authors recommend using means instead of summed scores; higher mean score indicates worse outcome (greater impact). Scale range: 0-4.
Time frame: 9 months after risk evaluation
Impact of Event Scale-Revised
22-item scale to assess subjective distress caused by traumatic events. Each item scored on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely"). Subscales can be calculated for Intrusion, Avoidance, and Hyperarousal. The authors recommend using means instead of summed scores; higher mean score indicates worse outcome (greater impact). Scale range: 0-4.
Time frame: 15 months after risk evaluation
Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)
15-20 minute test of cognitive differences in normal aging. Composite score (the average of standardized z-scores for six measures: immediate memory, delayed memory, working memory, verbal fluency, speed, and reasoning. Lower scores indicate worse outcome (worse memory performance). Range of scale values: -1 to +1.
Time frame: Baseline and 6 weeks after risk evaluation
Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)
15-20 minute test of cognitive differences in normal aging. Composite score (the average of standardized z-scores for six measures: immediate memory, delayed memory, working memory, verbal fluency, speed, and reasoning. Lower scores indicate worse outcome (worse memory performance). Range of scale values: -1 to +1.
Time frame: Baseline and 9 months after risk evaluation
Change in Score on the Brief Test of Adult Cognition by Telephone (BTACT)
15-20 minute test of cognitive differences in normal aging. Composite score (the average of standardized z-scores for six measures: immediate memory, delayed memory, working memory, verbal fluency, speed, and reasoning. Lower scores indicate worse outcome (worse memory performance). Range of scale values: -1 to +1.
Time frame: Baseline and 15 months after risk evaluation
Change in Score on the Metamemory in Adulthood Questionnaire-Revised
20-item test of subjective memory. Each item measured on a 5-point Likert scale from 1 (agree strongly) to 5 (disagree strongly). Lower scores indicate worse outcome (worse subjective memory functioning and more decline in memory across time). Scale range: 20-100.
Time frame: Baseline and 6 weeks after risk evaluation
Change in Score on the Metamemory in Adulthood Questionnaire-Revised
20-item test of subjective memory. Each item measured on a 5-point Likert scale from 1 (agree strongly) to 5 (disagree strongly). Lower scores indicate worse outcome (worse subjective memory functioning and more decline in memory across time). Scale range: 20-100.
Time frame: Baseline and 9 months after risk evaluation
Change in Score on the Metamemory in Adulthood Questionnaire-Revised
20-item test of subjective memory. Each item measured on a 5-point Likert scale from 1 (agree strongly) to 5 (disagree strongly). Lower scores indicate worse outcome (worse subjective memory functioning and more decline in memory across time). Scale range: 20-100.
Time frame: Baseline and 15 months after risk evaluation
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.
Time frame: Baseline and 6 weeks after risk evaluation
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.
Time frame: Baseline and 9 months after risk evaluation
Change in Score on Patient Health Questionnaire-9 (PHQ-9)
9-item screen for depressive symptoms. Each item rated by the frequency with which symptoms were experienced during the preceding 2 weeks (0-3, with 3 most frequent). Scores are summed; higher total indicates worse outcome (more depressive symptoms). Scale range: 0-27.
Time frame: Baseline and 15 months after risk evaluation
Change in Score on the General Anxiety Disorder-7 (GAD-7)
7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.
Time frame: Baseline and 6 weeks after risk evaluation
Change in Score on the General Anxiety Disorder-7 (GAD-7)
7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.
Time frame: Baseline and 9 months after risk evaluation
Change in Score on the General Anxiety Disorder-7 (GAD-7)
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7-item screen for anxiety symptoms. Each item rated by self-reported severity of a given symptom over the past 2 weeks from 0 (not at all) to 3 (nearly every day). Higher total score indicates worse outcome (more anxiety symptoms). Scale range: 0-21.
Time frame: Baseline and 15 months after risk evaluation
Change in Perceived Threat of AD
7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.
Time frame: Baseline and 6 weeks after risk evaluation
Change in Perceived Threat of AD
7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.
Time frame: Baseline and 9 months after risk evaluation
Change in Perceived Threat of AD
7-item scale to assess perceived threat of developing Alzheimer's disease. Each item rated on 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). Scores are summed; higher scores indicate worse outcome (more threat). Scale range: 7-35.
Time frame: Baseline and 15 months after risk evaluation
Health-related behavior changes
22 items, with each item answered yes (1) or no (0). Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).
Time frame: 6 weeks after risk evaluation
Health-related behavior changes
22 items, with each item answered yes (1) or no (0). Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).
Time frame: 9 months after risk evaluation
Health-related behavior changes
22 items, with each item answered yes (1) or no (0). Total value greater than 0 indicates better outcome (the participant made a change in diet, exercise, or medications/vitamins in response to receiving genetic information).
Time frame: 15 months after risk evaluation
Recall/understanding of results
5 questions will be asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.
Time frame: 6 weeks after risk evaluation
Recall/understanding of results
5 questions will be asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.
Time frame: 9 months after risk evaluation
Recall/understanding of results
5 questions will be asked to assess recall of results, each of which is answered correctly or incorrectly. Outcome is the total number of correct answers (0 thru 5). Higher score indicates better outcome.
Time frame: 15 months after risk evaluation