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Trial record 3 of 5 for:    Risk Evaluation and Education for Alzheimer's disease REVEAL

REVEAL III: Risk Evaluation and Education for Alzheimer's Disease (REVEAL)

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ClinicalTrials.gov Identifier: NCT00462917
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : September 11, 2014
Last Update Posted : September 11, 2014
Sponsor:
Collaborator:
National Human Genome Research Institute (NHGRI)
Information provided by (Responsible Party):
Robert C. Green, MD, MPH, Brigham and Women's Hospital

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Participant);   Primary Purpose: Health Services Research
Condition: Alzheimer Disease
Interventions: Behavioral: Pleiotropic info, in-person disclosure
Behavioral: AD-only info, in-person disclosure
Behavioral: Pleiotropic info, phone disclosure
Behavioral: AD-only info, phone disclosure

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Pleiotropic Info, In-person Disclosure

Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed in-person during an APOE-based genetic risk assessment

Pleiotropic info, in-person disclosure: 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.

AD-only Info, Phone Disclosure

Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment

AD-only info, phone disclosure: 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.

Pleiotropic Info, Phone Disclosure

Incidental pleiotropic risk information, in addition to Alzheimer's disease risk information, is disclosed via telephone during an APOE-based genetic risk assessment

Pleiotropic info, phone disclosure: 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.

AD-only Info, In-person Disclosure

Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment

AD-only info, in-person disclosure: 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.


Participant Flow:   Overall Study
    Pleiotropic Info, In-person Disclosure   AD-only Info, Phone Disclosure   Pleiotropic Info, Phone Disclosure   AD-only Info, In-person Disclosure
STARTED   72   75   66   77 
Met With Genetic Counselor   66   71   56   71 
Received Risk Information   64   70   55   68 
Completed 6 Week Follow-up   63   70   55   68 
Completed 6 Month Follow-up   63   68   55   66 
COMPLETED   62   65   54   66 
NOT COMPLETED   10   10   12   11 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Baseline population includes all participants who received genetic risk information, regardless of whether they completed follow-up time surveys.

Reporting Groups
  Description
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

Pleiotropic info, in-person disclosure: 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.

AD-only Info, Phone Disclosure

Alzheimer's disease risk information only is disclosed via telephone during an APOE-based genetic risk assessment

AD-only info, phone disclosure: 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.

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

Pleiotropic info, phone disclosure: 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.

AD-only Info, In-person Disclosure

Alzheimer's disease risk information only is disclosed in-person during an APOE-based genetic risk assessment

AD-only info, in-person disclosure: 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.

Total Total of all reporting groups

Baseline Measures
   Pleiotropic Info, In-person Disclosure   AD-only Info, Phone Disclosure   Pleiotropic Info, Phone Disclosure   AD-only Info, In-person Disclosure   Total 
Overall Participants Analyzed 
[Units: Participants]
 64   70   55   68   257 
Age 
[Units: Years]
Mean (Standard Deviation)
 57  (12)   57  (13)   59  (13)   59  (12)   58  (13) 
Gender 
[Units: Participants]
         
Female   36   39   29   37   141 
Male   28   31   26   31   116 
Race (NIH/OMB) 
[Units: Participants]
         
American Indian or Alaska Native   0   1   0   0   1 
Asian   0   0   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0   0   0 
Black or African American   5   13   4   16   38 
White   59   55   50   51   215 
More than one race   0   0   0   0   0 
Unknown or Not Reported   0   1   1   1   3 
Region of Enrollment 
[Units: Participants]
         
United States   64   70   55   68   257 
Anxiety (Beck Anxiety Index: BAI) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 2.7  (2.9)   3.6  (3.4)   3.8  (3.7)   4.0  (3.8)   3.5  (3.5) 
[1] Scores on the Beck Anxiety Index (BAI), a 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.
Depression (Center for Epidemiological Studies Depression Scale: CES-D) [1] 
[Units: Units on a scale]
Mean (Standard Deviation)
 5.1  (4.6)   5.5  (5.4)   5.5  (5.0)   6.6  (5.3)   5.7  (5.1) 
[1] Scores on the Center for Epidemiological Studies Depression Scale (CES-D), a 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.


  Outcome Measures

1.  Primary:   Center for Epidemiological Studies-Depression Scale (CES-D)   [ Time Frame: 6 weeks, 6 months, and 12 months post-disclosure ]

2.  Primary:   Beck Anxiety Inventory (BAI)   [ Time Frame: 6 weeks, 6 months, 12 months post-disclosure ]

3.  Secondary:   Impact of Events Scale (IES)   [ Time Frame: 6 weeks, 6 months, 12 months post-disclosure ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Robert C. Green, MD, MPH
Organization: Brigham and Women's Hospital and Harvard Medical School
phone: 617-264-5838
e-mail: rcgreen@genetics.med.harvard.edu


Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Robert C. Green, MD, MPH, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT00462917     History of Changes
Other Study ID Numbers: IA0113
R01HG002213 ( U.S. NIH Grant/Contract )
First Submitted: April 17, 2007
First Posted: April 19, 2007
Results First Submitted: August 21, 2014
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014