REVEAL III: Risk Evaluation and Education for Alzheimer's Disease (REVEAL)
Risk Evaluation and Education for Alzheimer's Disease
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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 that has been identified which can provide information about a person's chances of developing Alzheimer's diseases. Previous research explored the behavioral and psychological impact of receiving genetic risk information for Alzheimer's disease (AD). The REVEAL I Study, funded in 1999, showed that an Alzheimer's disease genetic risk assessment can be given to relatives of people with AD in a safe way. REVEAL II, which was funded in 2003, demonstrated that this same information can be given in a condensed education and counseling protocol without causing severe psychological harm. REVEAL III will further study different ways of providing genetic risk information for Alzheimer's disease.
Participation in this study will entail an initial screening phone call to determine eligibility, followed by a phone interview which will ask about demographic information and thoughts and feelings about AD. Participants will complete a mailed survey. Following completion of the survey, a genetic counselor will meet with the participant at the clinic to review family and medical history, administer additional questionnaires asking about AD and genetic testing, and draw blood for genetic testing. Results will be disclosed either in person or over the phone about 3 to 4 weeks later. The genetic counselor will make a brief follow-up phone call 1 week after that. The participant will visit the clinic twice to provide additional information, at 6 weeks and 6 months after disclosure. Finally, the participant will complete a mailed 12 month survey, and the genetic counselor will make a brief follow-up phone call.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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District of Columbia
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Washington, District of Columbia, Forenede Stater, 20059
- Howard University
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Massachusetts
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Boston, Massachusetts, Forenede Stater, 02118
- Boston University School of Medicine
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
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Ohio
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Cleveland, Ohio, Forenede Stater, 44120
- Case Western Reserve University
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Aged 18 years to 85 years old
Exclusion Criteria:
- Unable to visit a study site
- Current untreated depression or anxiety
- Family history of AD diagnosed under age 60
- More than one first-degree relative diagnosed with AD (e.g. Mother and brother)
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Sundhedstjenesteforskning
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Pleiotropic info, in-person disclosure
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed in-person during an APOE-based genetic risk assessment
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Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information. Genetic counselors communicate results to participants during an in-person disclosure session. |
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Eksperimentel: AD-only info, phone disclosure
Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment
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Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping. Genetic counselors communicate results to participants during an in-person disclosure session. |
|
Eksperimentel: Pleiotropic info, phone disclosure
Incidental pleiotropic risk information, in addition to AD risk information, is disclosed via telephone during an APOE-based genetic risk assessment
|
Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping as well as additional pleiotropic information. Genetic counselors communicate results to participants during a telephone disclosure session. |
|
Aktiv komparator: AD-only info, in-person disclosure
Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment
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Individuals are provided with a lifetime percentage risk of developing Alzheimer's disease based on APOE genotyping. Genetic counselors communicate results to participants during an in-person disclosure session. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Center for Epidemiological Studies-Depression Scale (CES-D)
Tidsramme: 6 weeks, 6 months, and 12 months post-disclosure
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A 20-item scale measuring general depression.
Scores range from 0-60, with higher scores indicating greater general depression.
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6 weeks, 6 months, and 12 months post-disclosure
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Beck Anxiety Inventory (BAI)
Tidsramme: 6 weeks, 6 months, 12 months post-disclosure
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A 21-item scale measuring general anxiety.
Scores range from 0-63, with higher scores indicating greater anxiety.
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6 weeks, 6 months, 12 months post-disclosure
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Impact of Events Scale (IES)
Tidsramme: 6 weeks, 6 months, 12 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.
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6 weeks, 6 months, 12 months post-disclosure
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Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Robert Green, MD, MPH, Brigham and Women's Hospital
Publikationer og nyttige links
Generelle publikationer
- Hipps YG, Roberts JS, Farrer LA, Green RC. Differences between African Americans and Whites in their attitudes toward genetic testing for Alzheimer's disease. Genet Test. 2003 Spring;7(1):39-44. doi: 10.1089/109065703321560921.
- Roberts JS, LaRusse SA, Katzen H, Whitehouse PJ, Barber M, Post SG, Relkin N, Quaid K, Pietrzak RH, Cupples LA, Farrer LA, Brown T, Green RC. Reasons for seeking genetic susceptibility testing among first-degree relatives of people with Alzheimer disease. Alzheimer Dis Assoc Disord. 2003 Apr-Jun;17(2):86-93. doi: 10.1097/00002093-200304000-00006.
- Roberts JS, Barber M, Brown TM, Cupples LA, Farrer LA, LaRusse SA, Post SG, Quaid KA, Ravdin LD, Relkin NR, Sadovnick AD, Whitehouse PJ, Woodard JL, Green RC. Who seeks genetic susceptibility testing for Alzheimer's disease? Findings from a multisite, randomized clinical trial. Genet Med. 2004 Jul-Aug;6(4):197-203. doi: 10.1097/01.gim.0000132688.55591.77.
- LaRusse S, Roberts JS, Marteau TM, Katzen H, Linnenbringer EL, Barber M, Whitehouse P, Quaid K, Brown T, Green RC, Relkin NR. Genetic susceptibility testing versus family history-based risk assessment: Impact on perceived risk of Alzheimer disease. Genet Med. 2005 Jan;7(1):48-53. doi: 10.1097/01.gim.0000151157.13716.6c.
- Roberts JS, Cupples LA, Relkin NR, Whitehouse PJ, Green RC; REVEAL (Risk Evaluation and Education for Alzheimer's Disease) Study Group. Genetic risk assessment for adult children of people with Alzheimer's disease: the Risk Evaluation and Education for Alzheimer's Disease (REVEAL) study. J Geriatr Psychiatry Neurol. 2005 Dec;18(4):250-5. doi: 10.1177/0891988705281883.
- 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.
- Christensen KD, Uhlmann WR, Roberts JS, Linnenbringer E, Whitehouse PJ, Royal CDM, Obisesan TO, Cupples LA, Butson MB, Fasaye GA, Hiraki S, Chen CA, Siebert U, Cook-Deegan R, Green RC. A randomized controlled trial of disclosing genetic risk information for Alzheimer disease via telephone. Genet Med. 2018 Jan;20(1):132-141. doi: 10.1038/gim.2017.103. Epub 2017 Jul 20.
- Christensen KD, Roberts JS, Whitehouse PJ, Royal CD, Obisesan TO, Cupples LA, Vernarelli JA, Bhatt DL, Linnenbringer E, Butson MB, Fasaye GA, Uhlmann WR, Hiraki S, Wang N, Cook-Deegan R, Green RC; REVEAL Study Group*. Disclosing Pleiotropic Effects During Genetic Risk Assessment for Alzheimer Disease: A Randomized Trial. Ann Intern Med. 2016 Feb 2;164(3):155-63. doi: 10.7326/M15-0187. Epub 2016 Jan 26.
- Christensen KD, Roberts JS, Zikmund-Fisher BJ, Kardia SL, McBride CM, Linnenbringer E, Green RC; REVEAL Study Group. Associations between self-referral and health behavior responses to genetic risk information. Genome Med. 2015 Jan 31;7(1):10. doi: 10.1186/s13073-014-0124-0. eCollection 2015.
- Besser AG, Sanderson SC, Roberts JS, Chen CA, Christensen KD, Lautenbach DM, Cupples LA, Green RC. Factors affecting recall of different types of personal genetic information about Alzheimer's disease risk: the REVEAL study. Public Health Genomics. 2015;18(2):78-86. doi: 10.1159/000368888. Epub 2015 Jan 24.
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IA0113
- R01HG002213 (U.S. NIH-bevilling/kontrakt)
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