Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV
24 de septiembre de 2018 actualizado por: Robert C. Green, MD, MPH, Brigham and Women's Hospital
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).
Descripción general del estudio
Estado
Terminado
Condiciones
Intervención / Tratamiento
Descripción detallada
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 de estudio
Intervencionista
Inscripción (Actual)
146
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
District of Columbia
-
Washington, District of Columbia, Estados Unidos, 20060
- Howard University
-
-
Michigan
-
Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Estados Unidos, 19104
- University of Pennsylvania
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Investigación de servicios de salud
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: APOE Genotype Non-Disclosure
Subjects will receive Alzheimer's disease risk disclosure.
This assessment is based on age and MCI status alone.
|
Subjects with MCI will learn a three-year numerical risk estimate for the chance of progressing to dementia of the Alzheimer's type.
|
|
Experimental: 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.
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Geriatric Depression Scale
Periodo de tiempo: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
|
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
|
|
Mini State Trait Anxiety Inventory
Periodo de tiempo: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
|
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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Impact of Event Scale (IES)
Periodo de tiempo: 1-3 Days, 6 Weeks and 6 Months Post-disclosure
|
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
|
|
Psychological Impact of Test Disclosure (IGT-AD)
Periodo de tiempo: 6 Weeks and 6 Months Post-disclosure
|
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
|
|
Recall and Comprehension of Risk Information
Periodo de tiempo: 6 Weeks and 6 Months Post-disclosure
|
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
|
|
Participant Satisfaction
Periodo de tiempo: 6 Weeks and 6 Months Post-disclosure
|
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
|
|
User Ratings of Risk Assessment Experience
Periodo de tiempo: 6 Weeks and 6 Months Post-disclosure
|
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
|
|
Health Behavior and Insurance Changes
Periodo de tiempo: Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
|
AD prevention behaviors enacted within the prior two weeks.
|
Baseline, 6 weeks post-disclosure, and 6 months post-disclosure
|
|
Insurance and Advance Planning Changes
Periodo de tiempo: 6 months post-disclosure
|
A series of yes/no questions that ask whether the risk assessment motivated changes to insurance or advance planning.
|
6 months post-disclosure
|
|
Participation in Alzheimer's Disease-related Research After Receiving the Alzheimer's Disease Risk Estimate.
Periodo de tiempo: 6 weeks and 6 months post-disclosure
|
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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Robert C Green, MD, MPH, Brigham and Women's Hospital/Harvard Medical School
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de enero de 2010
Finalización primaria (Actual)
1 de julio de 2014
Finalización del estudio (Actual)
1 de julio de 2014
Fechas de registro del estudio
Enviado por primera vez
7 de septiembre de 2011
Primero enviado que cumplió con los criterios de control de calidad
14 de septiembre de 2011
Publicado por primera vez (Estimar)
15 de septiembre de 2011
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
23 de octubre de 2018
Última actualización enviada que cumplió con los criterios de control de calidad
24 de septiembre de 2018
Última verificación
1 de septiembre de 2018
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- R01HG002213 (Subvención/contrato del NIH de EE. UU.)
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .