Mild Cognitive Impairment Clinical Trial
Official title:
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Verified date | September 2018 |
Source | Brigham and Women's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study is intended to examine the impact of receiving a genetic risk assessment for Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).
Status | Completed |
Enrollment | 146 |
Est. completion date | July 2014 |
Est. primary completion date | July 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Individuals (55-90 years old) with Mild Cognitive Impairment (amnestic-MCI as defined by the Petersen criteria) - Individuals who have a close friend, relative or spouse (18+) willing to be a study partner. Study partners attend each study visit with the participant and also complete surveys and interviews. Exclusion Criteria: - Individuals with current, untreated anxiety or depression - Individuals who do not meet the criteria for amnestic-MCI - Individuals who have the diagnosis of dementia or Alzheimer's disease - Individuals not fluent in English - Individuals who do not have a study partner |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | University of Pennsylvania | Philadelphia | Pennsylvania |
United States | Howard University | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Brigham and Women's Hospital | Howard University, National Human Genome Research Institute (NHGRI), University of Michigan, University of Pennsylvania |
United States,
Guan Y, Roter DL, Erby LH, Wolff JL, Gitlin LN, Roberts JS, Green RC, Christensen KD. Disclosing genetic risk of Alzheimer's disease to cognitively impaired patients and visit companions: Findings from the REVEAL Study. Patient Educ Couns. 2017 May;100(5) — View Citation
Guan Y, Roter DL, Wolff JL, Gitlin LN, Christensen KD, Roberts JS, Green RC, Erby LH. The impact of genetic counselors' use of facilitative strategies on cognitive and emotional processing of genetic risk disclosure for Alzheimer's disease. Patient Educ C — View Citation
Roberts JS, Christensen KD, Green RC. Using Alzheimer's disease as a model for genetic risk disclosure: implications for personal genomics. Clin Genet. 2011 Nov;80(5):407-14. doi: 10.1111/j.1399-0004.2011.01739.x. Epub 2011 Jul 18. Review. — View Citation
Roberts JS, Karlawish JH, Uhlmann WR, Petersen RC, Green RC. Mild cognitive impairment in clinical care: a survey of American Academy of Neurology members. Neurology. 2010 Aug 3;75(5):425-31. doi: 10.1212/WNL.0b013e3181eb5872. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Geriatric Depression Scale | A 15-item self-report assessment used to identify depression in the elderly. GDS scores ranged from 0-15. Higher scores indicated greater depression. | Baseline, 6 weeks post-disclosure, and 6 months post-disclosure | |
Primary | Mini State Trait Anxiety Inventory | Validated introspective psychological inventory consisting of 6 self-report items pertaining to anxiety affect. Responses are transformed into scores that range from 20 to 80, with higher scores indicating greater anxiety. | Baseline, 6 weeks post-disclosure, and 6 months post-disclosure | |
Secondary | Impact of Event Scale (IES) | The Impact of Event assesses intrusive thoughts and avoidance related to a specific stressful life event. It is a 15-item self-report measure with scores that range from 0 to 75, with greater scores indicating greater distress about the event. | 1-3 Days, 6 Weeks and 6 Months Post-disclosure | |
Secondary | Psychological Impact of Test Disclosure (IGT-AD) | A 15-item scale measuring distress specific to the test results received. Scores range from 0-75, with higher scores indicating greater test-related distress. Higher scores indicate greater distress about the risk assessment. | 6 Weeks and 6 Months Post-disclosure | |
Secondary | Recall and Comprehension of Risk Information | Several measures to assess participant recall and comprehension of personalized risk information for AD. The sum number correct of the two items that were presented to both randomization arms ("What form of APOE increases risk for Alzheimer's disease?", and "What percentage were you given as your 3-year risk of developing Alzheimer's disease?") are summarized here. | 6 Weeks and 6 Months Post-disclosure | |
Secondary | Participant Satisfaction | How well participants' expectations about information, explanations, reassurance, advice, and help in decision making were met. Participants rated satisfaction for each dimension on a 1-7 scale, with higher scores indicating that expectations were met better. | 6 Weeks and 6 Months Post-disclosure | |
Secondary | User Ratings of Risk Assessment Experience | Subjective ratings of the impact of risk assessment. Participants provided ratings on a 1-5 scale, with 1 being "very negative" and 5 being "very positive" | 6 Weeks and 6 Months Post-disclosure | |
Secondary | Health Behavior and Insurance Changes | AD prevention behaviors enacted within the prior two weeks. | Baseline, 6 weeks post-disclosure, and 6 months post-disclosure | |
Secondary | Insurance and Advance Planning Changes | A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning. | 6 months post-disclosure | |
Secondary | Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate. | Yes/no response to the question, "Since receiving your Alzheimer's disease risk estimate, have you joined any other Alzheimer's disease-related research studies?" | 6 weeks and 6 months post-disclosure |
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