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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00462917
Recruitment Status : Completed
First Posted : April 19, 2007
Results First Posted : September 11, 2014
Last Update Posted : October 23, 2018
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
Enrollment 290
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pleiotropic Info, In-person Disclosure AD-only Info, Phone Disclosure Pleiotropic Info, Phone Disclosure AD-only Info, In-person Disclosure
Hide Arm/Group Description

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.

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.

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.

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.

Period Title: Overall Study
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
Arm/Group Title Pleiotropic Info, In-person Disclosure AD-only Info, Phone Disclosure Pleiotropic Info, Phone Disclosure AD-only Info, In-person Disclosure Total
Hide Arm/Group Description

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.

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 64 70 55 68 257
Hide Baseline Analysis Population Description
Baseline population includes all participants who received genetic risk information, regardless of whether they completed follow-up time surveys.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 64 participants 70 participants 55 participants 68 participants 257 participants
57  (12) 57  (13) 59  (13) 59  (12) 58  (13)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 70 participants 55 participants 68 participants 257 participants
Female
36
  56.3%
39
  55.7%
29
  52.7%
37
  54.4%
141
  54.9%
Male
28
  43.8%
31
  44.3%
26
  47.3%
31
  45.6%
116
  45.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 64 participants 70 participants 55 participants 68 participants 257 participants
American Indian or Alaska Native
0
   0.0%
1
   1.4%
0
   0.0%
0
   0.0%
1
   0.4%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
   7.8%
13
  18.6%
4
   7.3%
16
  23.5%
38
  14.8%
White
59
  92.2%
55
  78.6%
50
  90.9%
51
  75.0%
215
  83.7%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
1
   1.4%
1
   1.8%
1
   1.5%
3
   1.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 64 participants 70 participants 55 participants 68 participants 257 participants
64 70 55 68 257
Anxiety (Beck Anxiety Index: BAI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 64 participants 70 participants 55 participants 68 participants 257 participants
2.7  (2.9) 3.6  (3.4) 3.8  (3.7) 4.0  (3.8) 3.5  (3.5)
[1]
Measure Description: 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] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 64 participants 70 participants 55 participants 68 participants 257 participants
5.1  (4.6) 5.5  (5.4) 5.5  (5.0) 6.6  (5.3) 5.7  (5.1)
[1]
Measure Description: 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.
1.Primary Outcome
Title Center for Epidemiological Studies-Depression Scale (CES-D)
Hide Description A 20-item scale measuring general depression. Scores range from 0-60, with higher scores indicating greater general depression.
Time Frame 6 weeks, 6 months, and 12 months post-disclosure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
"Number of participants analyzed" are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data.
Arm/Group Title Pleiotropic Info, In-person Disclosure AD-only Info, Phone Disclosure Pleiotropic Info, Phone Disclosure AD-only Info, In-person Disclosure
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 63 70 55 68
Mean (Standard Deviation)
Unit of Measure: score on a scale
6 Weeks Number Analyzed 63 participants 70 participants 55 participants 68 participants
4.8  (5.0) 7.0  (8.4) 6.4  (6.4) 5.5  (5.4)
6 Months Number Analyzed 63 participants 68 participants 55 participants 66 participants
5.5  (7.0) 6.6  (6.7) 5.8  (6.4) 6.1  (6.6)
12 Months Number Analyzed 62 participants 65 participants 54 participants 66 participants
7.1  (8.2) 7.6  (9.0) 7.1  (7.0) 6.2  (6.9)
2.Primary Outcome
Title Beck Anxiety Inventory (BAI)
Hide Description A 21-item scale measuring general anxiety. Scores range from 0-63, with higher scores indicating greater anxiety.
Time Frame 6 weeks, 6 months, 12 months post-disclosure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
"Number of participants analyzed" are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data.
Arm/Group Title Pleiotropic Info, In-person Disclosure AD-only Info, Phone Disclosure Pleiotropic Info, Phone Disclosure AD-only Info, In-person Disclosure
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 63 70 55 68
Mean (Standard Deviation)
Unit of Measure: score on a scale
6 Weeks Number Analyzed 63 participants 70 participants 55 participants 68 participants
2.9  (3.6) 4.1  (5.4) 3.2  (4.2) 3.1  (3.3)
6 Months Number Analyzed 63 participants 68 participants 55 participants 66 participants
3.4  (5.4) 3.4  (4.3) 3.3  (3.8) 3.0  (5.0)
12 Months Number Analyzed 62 participants 65 participants 54 participants 66 participants
3.4  (5.5) 4.0  (5.3) 3.5  (3.4) 3.8  (4.8)
3.Secondary Outcome
Title Impact of Events Scale (IES)
Hide Description 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.
Time Frame 6 weeks, 6 months, 12 months post-disclosure
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
"Number of participants analyzed" are the number of participants who received genetic risk information and completed the 6-week follow-up (256). At 6 months, 252 participants provided data. At 12 months, 247 participants provided data.
Arm/Group Title Pleiotropic Info, In-person Disclosure AD-only Info, Phone Disclosure Pleiotropic Info, Phone Disclosure AD-only Info, In-person Disclosure
Hide Arm/Group Description:

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.

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.

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.

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.

Overall Number of Participants Analyzed 63 70 55 68
Mean (Standard Deviation)
Unit of Measure: score on a scale
6 Weeks Number Analyzed 63 participants 70 participants 55 participants 68 participants
3.4  (6.4) 4.5  (7.9) 3.7  (6.3) 3.8  (7.7)
6 Months Number Analyzed 63 participants 68 participants 55 participants 66 participants
3.5  (8.7) 4.0  (8.2) 3.0  (4.2) 3.2  (5.8)
12 Months Number Analyzed 62 participants 65 participants 54 participants 66 participants
2.4  (5.9) 4.0  (10.4) 2.5  (5.2) 3.3  (7.4)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pleiotropic Info, In-person Disclosure AD-only Info, Phone Disclosure Pleiotropic Info, Phone Disclosure AD-only Info, In-person Disclosure
Hide Arm/Group Description

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.

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.

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.

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.

All-Cause Mortality
Pleiotropic Info, In-person Disclosure AD-only Info, Phone Disclosure Pleiotropic Info, Phone Disclosure AD-only Info, In-person Disclosure
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Pleiotropic Info, In-person Disclosure AD-only Info, Phone Disclosure Pleiotropic Info, Phone Disclosure AD-only Info, In-person Disclosure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/64 (1.56%)      0/70 (0.00%)      0/55 (0.00%)      0/68 (0.00%)    
Social circumstances         
Death *  1/64 (1.56%)  1 0/70 (0.00%)  0 0/55 (0.00%)  0 0/68 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 2%
Pleiotropic Info, In-person Disclosure AD-only Info, Phone Disclosure Pleiotropic Info, Phone Disclosure AD-only Info, In-person Disclosure
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   8/64 (12.50%)      9/70 (12.86%)      4/55 (7.27%)      5/68 (7.35%)    
General disorders         
Hospitalization * [1]  3/64 (4.69%)  3 1/70 (1.43%)  1 0/55 (0.00%)  0 0/68 (0.00%)  0
Psychiatric disorders         
Potential mood disorder  [2]  5/64 (7.81%)  5 8/70 (11.43%)  8 4/55 (7.27%)  6 5/68 (7.35%)  5
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
[1]
Participant was hospitalized. Events are reported regardless of whether they are study-related
[2]
BAI or CES-D scores above standard cutoffs for severe anxiety or depression, respectively; or increases of at least 15 points from baseline on BAI or CES-D scores at any follow up. Events are noted regardless of whether they are study-related
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
Other Publications:
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: October 23, 2018