Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene which can provide information about a person's chances of developing Alzheimer's disease.
Some people with a diagnosis of Mild Cognitive Impairment (MCI) are curious to learn more about the chance of developing Alzheimer's disease. In the REVEAL IV Study, we are examining the psychological and behavioral impact of learning genetic risk information pertaining to the chance for an individual with MCI to progress to dementia of the Alzheimer's type within three years.
Participation in this study requires an initial phone call which will elicit some demographic information about the participant and his or her study partner. A first in-person visit to the research clinic will consist of an education session, the administration of knowledge and attitudinal surveys and some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Participants with MCI will have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the intervention arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age, the diagnosis of MCI and their own APOE gene test result. Those in the comparison arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age and the diagnosis of MCI, without the APOE gene test result. Participants randomized to the comparison arm will have the opportunity to learn their own APOE gene test result at the end of the study. Participants and their study partners will be followed for 6 months following disclosure of results with 1 additional clinic visit and 1 additional phone interviews.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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District of Columbia
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Washington, District of Columbia, Stati Uniti, 20060
- Howard University
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Michigan
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Ann Arbor, Michigan, Stati Uniti, 48109
- University of Michigan
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Pennsylvania
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Philadelphia, Pennsylvania, Stati Uniti, 19104
- University of Pennsylvania
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore attivo: APOE Genotype Non-Disclosure
Subjects will receive Alzheimer's disease risk disclosure.
This assessment is based on age and MCI status alone.
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Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
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Sperimentale: APOE Genotype Disclosure
Subjects will receive both APOE genotype and Alzheimer's disease risk disclosure.
The assessment is based on age, MCI status, and genotype.
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Subjects with MCI will learn their own APOE genotype and a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Geriatric Depression Scale
Lasso di tempo: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
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A 15-item self-report assessment used to identify depression in the elderly.
GDS scores ranged from 0-15.
Higher scores indicated greater depression.
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Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
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Mini State Trait Anxiety Inventory
Lasso di tempo: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
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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.
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Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Impact of Event Scale (IES)
Lasso di tempo: 1-3 Days, 6 Weeks and 6 Months Post-disclosure
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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.
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1-3 Days, 6 Weeks and 6 Months Post-disclosure
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Psychological Impact of Test Disclosure (IGT-AD)
Lasso di tempo: 6 Weeks and 6 Months Post-disclosure
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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.
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6 Weeks and 6 Months Post-disclosure
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Recall and Comprehension of Risk Information
Lasso di tempo: 6 Weeks and 6 Months Post-disclosure
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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.
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6 Weeks and 6 Months Post-disclosure
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Participant Satisfaction
Lasso di tempo: 6 Weeks and 6 Months Post-disclosure
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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.
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6 Weeks and 6 Months Post-disclosure
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User Ratings of Risk Assessment Experience
Lasso di tempo: 6 Weeks and 6 Months Post-disclosure
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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"
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6 Weeks and 6 Months Post-disclosure
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Health Behavior and Insurance Changes
Lasso di tempo: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
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AD prevention behaviors enacted within the prior two weeks.
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Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
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Insurance and Advance Planning Changes
Lasso di tempo: 6 months post-disclosure
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A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.
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6 months post-disclosure
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Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.
Lasso di tempo: 6 weeks and 6 months post-disclosure
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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?"
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6 weeks and 6 months post-disclosure
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Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Robert C Green, MD, MPH, Brigham and Women's Hospital/Harvard Medical School
Pubblicazioni e link utili
Pubblicazioni generali
- 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.
- 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.
- 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 Couns. 2018 May;101(5):817-823. doi: 10.1016/j.pec.2017.11.019. Epub 2017 Nov 27.
- 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):927-935. doi: 10.1016/j.pec.2016.12.005. Epub 2016 Dec 14.
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Altri numeri di identificazione dello studio
- R01HG002213 (Sovvenzione/contratto NIH degli Stati Uniti)
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