Trial Outcomes & Findings for Computerized Cognitive Training for Diabetic Elderly Veterans (NCT NCT01736124)
NCT ID: NCT01736124
Last Updated: 2023-07-27
Results Overview
The data below represent values of the Diabetes Self-Management Questionnaire (DSMQ) scores at 6 months post-intervention, the primary outcome. DSMQ scores range from 0 to 20, with higher scores indicating better self-management, the same as baseline.
COMPLETED
PHASE4
199 participants
6 months after the intervention
2023-07-27
Participant Flow
Recruitment Period: 4/7/2015 to 1/11/2018 Primary Recruitment Outreach: Mailings to potential participants Recruitment locations: James J. Peters Veterans Affairs Medical Center, Bronx, New York \& Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan
Review of demographic and medical records in the VA's Computerized Patient Record System, baseline assessment of diabetes self-management and cognitive functions, assessment of computer/internet availability, identification of a potential informant. 199 Veterans enrolled, but 19 were subsequently excluded prior to randomization
Participant milestones
| Measure |
Computerized Cognitive Training (CCT)
Randomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits.
computerized cognitive training: A variety of computer games tailored to address their personal cognitive deficits.
|
Active Control
Randomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills.
control games: A variety of computer games that are engaging but not designed to enhance cognitive skills
|
|---|---|---|
|
Baseline
STARTED
|
90
|
90
|
|
Baseline
COMPLETED
|
90
|
90
|
|
Baseline
NOT COMPLETED
|
0
|
0
|
|
Post-intervention Assessment
STARTED
|
90
|
90
|
|
Post-intervention Assessment
COMPLETED
|
59
|
69
|
|
Post-intervention Assessment
NOT COMPLETED
|
31
|
21
|
|
6 Mo. Post-Intervention Assessment
STARTED
|
62
|
70
|
|
6 Mo. Post-Intervention Assessment
COMPLETED
|
57
|
58
|
|
6 Mo. Post-Intervention Assessment
NOT COMPLETED
|
5
|
12
|
|
12 Mo. Post-Intervention Assessment
STARTED
|
58
|
62
|
|
12 Mo. Post-Intervention Assessment
COMPLETED
|
46
|
50
|
|
12 Mo. Post-Intervention Assessment
NOT COMPLETED
|
12
|
12
|
Reasons for withdrawal
| Measure |
Computerized Cognitive Training (CCT)
Randomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits.
computerized cognitive training: A variety of computer games tailored to address their personal cognitive deficits.
|
Active Control
Randomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills.
control games: A variety of computer games that are engaging but not designed to enhance cognitive skills
|
|---|---|---|
|
Post-intervention Assessment
Death
|
2
|
2
|
|
Post-intervention Assessment
lost computer access
|
1
|
1
|
|
Post-intervention Assessment
Moved away
|
3
|
1
|
|
Post-intervention Assessment
Withdrawal by Subject
|
11
|
9
|
|
Post-intervention Assessment
Illness
|
3
|
2
|
|
Post-intervention Assessment
Lost to Follow-up
|
8
|
5
|
|
Post-intervention Assessment
Temporarily away
|
3
|
1
|
|
6 Mo. Post-Intervention Assessment
Death
|
0
|
1
|
|
6 Mo. Post-Intervention Assessment
Moved away
|
0
|
2
|
|
6 Mo. Post-Intervention Assessment
Withdrawal by Subject
|
3
|
3
|
|
6 Mo. Post-Intervention Assessment
Illness
|
1
|
2
|
|
6 Mo. Post-Intervention Assessment
Temporarily away
|
1
|
4
|
|
12 Mo. Post-Intervention Assessment
Death
|
1
|
0
|
|
12 Mo. Post-Intervention Assessment
Moved away
|
1
|
0
|
|
12 Mo. Post-Intervention Assessment
Withdrawal by Subject
|
0
|
2
|
|
12 Mo. Post-Intervention Assessment
End of study
|
10
|
10
|
Baseline Characteristics
4 participants missing HBA1c
Baseline characteristics by cohort
| Measure |
Computerized Cognitive Training (CCT)
n=90 Participants
Randomly selected subjects perform adaptive computerized cognitive training (CCT) program, CognifitTM\], involving a variety of computer games tailored to address their personal cognitive deficits. Cognifit is a web-accessed CCT program designed to improve cognition by targeting the user's weaker cognitive functions. The challenge at each session was adapted according to the user's prior performance and a cognitive score pertaining to the specific session was provided. Participants were instructed to have sessions three times per week for eight weeks, with at least one day of rest between sessions, for a total of 24 sessions. Each 20 minute session included a unique combination of three games accessing a variety of cognitive abilities.
|
Active Control
n=90 Participants
As for the CCT intervention group, these randomly selected subjects performed three games each session from the same set of Cognifit computer games over the same eight week schedule. The activity differed only in the program did not target training games nor adaptive in their level of challenge based on prior performance and no cognitive score was provided at the end of the session.
|
Total
n=180 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
69.6 years
STANDARD_DEVIATION 6.5 • n=90 Participants
|
70.7 years
STANDARD_DEVIATION 6.6 • n=90 Participants
|
70.1 years
STANDARD_DEVIATION 6.6 • n=180 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=90 Participants
|
3 Participants
n=90 Participants
|
4 Participants
n=180 Participants
|
|
Sex: Female, Male
Male
|
89 Participants
n=90 Participants
|
87 Participants
n=90 Participants
|
176 Participants
n=180 Participants
|
|
Race/Ethnicity, Customized
White, non-Hispanic
|
48 Participants
n=90 Participants
|
43 Participants
n=90 Participants
|
91 Participants
n=180 Participants
|
|
Race/Ethnicity, Customized
Black, non-Hispanic
|
25 Participants
n=90 Participants
|
27 Participants
n=90 Participants
|
52 Participants
n=180 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
15 Participants
n=90 Participants
|
19 Participants
n=90 Participants
|
34 Participants
n=180 Participants
|
|
Race/Ethnicity, Customized
other/unknown
|
2 Participants
n=90 Participants
|
1 Participants
n=90 Participants
|
3 Participants
n=180 Participants
|
|
Region of Enrollment
United States
|
90 Participants
n=90 Participants
|
90 Participants
n=90 Participants
|
180 Participants
n=180 Participants
|
|
Years of Education
|
14.4 years
STANDARD_DEVIATION 2.3 • n=90 Participants
|
14.3 years
STANDARD_DEVIATION 2.7 • n=90 Participants
|
14.3 years
STANDARD_DEVIATION 2.5 • n=180 Participants
|
|
Site
James J. Peters VAMC, Bronx, NY
|
53 Participants
n=90 Participants
|
52 Participants
n=90 Participants
|
105 Participants
n=180 Participants
|
|
Site
Ann Arbor VAMC, Ann Arbor, MI
|
37 Participants
n=90 Participants
|
38 Participants
n=90 Participants
|
75 Participants
n=180 Participants
|
|
Clinical Dementia Rating (CDR) Scale
CDR = 0
|
77 Participants
n=90 Participants
|
74 Participants
n=90 Participants
|
151 Participants
n=180 Participants
|
|
Clinical Dementia Rating (CDR) Scale
CDR = 0.5
|
13 Participants
n=90 Participants
|
16 Participants
n=90 Participants
|
29 Participants
n=180 Participants
|
|
Mini-Mental Status Exam (MMSE)
|
28.5 units on a scale
STANDARD_DEVIATION 1.3 • n=90 Participants
|
28.3 units on a scale
STANDARD_DEVIATION 1.4 • n=90 Participants
|
28.4 units on a scale
STANDARD_DEVIATION 1.4 • n=180 Participants
|
|
Diabetes Self-Management Questionnaire (DSMQ)
|
14.2 units on a scale
STANDARD_DEVIATION 2.3 • n=90 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 2.4 • n=90 Participants
|
14.3 units on a scale
STANDARD_DEVIATION 2.3 • n=180 Participants
|
|
Hemoglobin A1c (HbA1c)
|
7.7 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.5 • n=88 Participants • 4 participants missing HBA1c
|
7.5 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.2 • n=88 Participants • 4 participants missing HBA1c
|
7.6 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.4 • n=176 Participants • 4 participants missing HBA1c
|
|
Systolic Blood Pressure
|
133.5 mmHg
STANDARD_DEVIATION 18.7 • n=88 Participants • 4 participants were missing on this measure
|
131.8 mmHg
STANDARD_DEVIATION 17.7 • n=88 Participants • 4 participants were missing on this measure
|
132.7 mmHg
STANDARD_DEVIATION 18.2 • n=176 Participants • 4 participants were missing on this measure
|
|
Diastolic Blood Pressure
|
74.7 mmHg
STANDARD_DEVIATION 10.3 • n=88 Participants • 4 participants were missing on this measure
|
73.6 mmHg
STANDARD_DEVIATION 10.8 • n=88 Participants • 4 participants were missing on this measure
|
74.1 mmHg
STANDARD_DEVIATION 10.5 • n=176 Participants • 4 participants were missing on this measure
|
|
Memory Score
|
-0.009 average of z-scores
STANDARD_DEVIATION 0.723 • n=85 Participants • For analysis, memory was calculated only for participants with at least 14 of 16 neuropsychological test scores (169 at baseline). Non-missing scores of each memory test were converted to z-scores and averaged for the participant.
|
0.009 average of z-scores
STANDARD_DEVIATION 0.800 • n=84 Participants • For analysis, memory was calculated only for participants with at least 14 of 16 neuropsychological test scores (169 at baseline). Non-missing scores of each memory test were converted to z-scores and averaged for the participant.
|
0.000 average of z-scores
STANDARD_DEVIATION 0.760 • n=169 Participants • For analysis, memory was calculated only for participants with at least 14 of 16 neuropsychological test scores (169 at baseline). Non-missing scores of each memory test were converted to z-scores and averaged for the participant.
|
|
Attention/Executive Functions
|
-0.017 average of z-scores
STANDARD_DEVIATION 0.613 • n=85 Participants • For analysis, attention/executive functions was calculated only for participants with at least 14 of 16 neuropsychological test scores (169 at baseline). Non-missing scores of each attention/executive function test were converted to z-scores and averaged for the participant.
|
0.017 average of z-scores
STANDARD_DEVIATION 0.628 • n=84 Participants • For analysis, attention/executive functions was calculated only for participants with at least 14 of 16 neuropsychological test scores (169 at baseline). Non-missing scores of each attention/executive function test were converted to z-scores and averaged for the participant.
|
0.000 average of z-scores
STANDARD_DEVIATION 0.619 • n=169 Participants • For analysis, attention/executive functions was calculated only for participants with at least 14 of 16 neuropsychological test scores (169 at baseline). Non-missing scores of each attention/executive function test were converted to z-scores and averaged for the participant.
|
|
Rivermead Behavioral Memory Prospective Memory (Appointments Subtest)
|
2.8 units on a scale
STANDARD_DEVIATION 1.3 • n=83 Participants • 12 participants were missing on this assessment.
|
2.7 units on a scale
STANDARD_DEVIATION 1.3 • n=85 Participants • 12 participants were missing on this assessment.
|
2.8 units on a scale
STANDARD_DEVIATION 1.3 • n=168 Participants • 12 participants were missing on this assessment.
|
|
Medication Adherence
|
0.150 percentage of refill gap-days per year
STANDARD_DEVIATION 0.107 • n=75 Participants • Medication data was derived from the VA's Computerized Patient Record System (CPRS). Not all participants obtained their medications from the VA.
|
0.146 percentage of refill gap-days per year
STANDARD_DEVIATION 0.142 • n=75 Participants • Medication data was derived from the VA's Computerized Patient Record System (CPRS). Not all participants obtained their medications from the VA.
|
0.148 percentage of refill gap-days per year
STANDARD_DEVIATION 0.125 • n=150 Participants • Medication data was derived from the VA's Computerized Patient Record System (CPRS). Not all participants obtained their medications from the VA.
|
|
Cognitive Self-Report Questionnaire (CSRQ)
|
63.4 units on a scale
STANDARD_DEVIATION 12.8 • n=84 Participants • Not all participants completed this assessment.
|
62.3 units on a scale
STANDARD_DEVIATION 14.1 • n=83 Participants • Not all participants completed this assessment.
|
62.9 units on a scale
STANDARD_DEVIATION 13.4 • n=167 Participants • Not all participants completed this assessment.
|
|
Geriatric Depression Scale
|
7.0 units on a scale
STANDARD_DEVIATION 6.2 • n=83 Participants • Not all participants completed this assessment.
|
6.3 units on a scale
STANDARD_DEVIATION 6.4 • n=83 Participants • Not all participants completed this assessment.
|
6.6 units on a scale
STANDARD_DEVIATION 6.3 • n=166 Participants • Not all participants completed this assessment.
|
|
Short -Test of Functional Health Literacy in Adults
|
32.3 units on a scale
STANDARD_DEVIATION 6.0 • n=90 Participants
|
33.5 units on a scale
STANDARD_DEVIATION 3.5 • n=90 Participants
|
32.9 units on a scale
STANDARD_DEVIATION 5.0 • n=180 Participants
|
PRIMARY outcome
Timeframe: 6 months after the interventionThe data below represent values of the Diabetes Self-Management Questionnaire (DSMQ) scores at 6 months post-intervention, the primary outcome. DSMQ scores range from 0 to 20, with higher scores indicating better self-management, the same as baseline.
Outcome measures
| Measure |
Adaptive CCT
n=57 Participants
Participants engaged in computerized cognitive training program involving games meant to enhance specific cognitive skills; the specific games presented and their level of challenge adapted to the prior performance of the participant.
|
Active Control
n=58 Participants
Participants were presented with the same CCT games but presentation was not dependent on prior performance and the challenge level did not change.
|
|---|---|---|
|
Diabetes Self-management
|
14.9 score on a scale
Standard Deviation 2.4
|
15.1 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 12 months post-interventionPopulation: Some participants did not use VA pharmacy for medication reducing samples in groups.
Medication adherence was assessed by the Continuous Multiple interval measure of Gaps in therapy (CMG), using diabetes medication refill data from the CPRS for the full year post-intervention. To calculate CMG percentage, the total number of days without medication refills when due - refill gap-days - was divided by 365, the days in a year. Multiplying this fraction by 100 provides the CMG percentage, where a higher percentage indicates worse medication adherence. The data below represent the CMG percentage at 12 months post-intervention.
Outcome measures
| Measure |
Adaptive CCT
n=49 Participants
Participants engaged in computerized cognitive training program involving games meant to enhance specific cognitive skills; the specific games presented and their level of challenge adapted to the prior performance of the participant.
|
Active Control
n=55 Participants
Participants were presented with the same CCT games but presentation was not dependent on prior performance and the challenge level did not change.
|
|---|---|---|
|
Medication Adherence
|
0.11 percentage of refill gap-days
Standard Deviation 0.10
|
0.14 percentage of refill gap-days
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: 6 month after the interventionPopulation: Two active control participants did not complete neuropsychological test battery.
As with baseline memory score, the outcome score was the mean of Word List Memory and Logical Memory (Story A) tests, each providing three scores: immediate recall, delayed recall, and recognition tasks after conversion to a common unit of measurement. However, to standardize these outcome tasks, the statistics from which the baseline z-scores were calculated (mean\_baseline and SD\_baseline from the full sample before randomization) were used, rather than the means of the given outcome period: standardized score = (outcome task score - mean\_baseline) / SD\_baseline. Thus, while baseline task scores were conventional z-scores, the six-month post-intervention standardized scores were not, in order to best inform the outcome measure and better facilitate comparison with baseline. The data below represent outcome values at 6 months. Like the baseline measure, this measure does not have a theoretical minimum or maximum, and higher scores indicate better performance.
Outcome measures
| Measure |
Adaptive CCT
n=57 Participants
Participants engaged in computerized cognitive training program involving games meant to enhance specific cognitive skills; the specific games presented and their level of challenge adapted to the prior performance of the participant.
|
Active Control
n=56 Participants
Participants were presented with the same CCT games but presentation was not dependent on prior performance and the challenge level did not change.
|
|---|---|---|
|
Memory
|
0.652 units on a scale
Standard Deviation 0.594
|
0.460 units on a scale
Standard Deviation 0.738
|
SECONDARY outcome
Timeframe: 6 months after the interventionPopulation: Two active control participants did not complete neuropsychological test battery.
As with baseline attention/executive function score, the outcome score was the mean of the Target Cancellation (TMX, Diamond), Trail Making (A, B; reversed), Digit Symbol Substitution, and, Digit Span (Forward, Backward) tasks after conversion to a common unit of measurement. However, to standardize these outcome tasks, the statistics from which the baseline z-scores were calculated (mean\_baseline and SD\_baseline from the full sample before randomization) were used, rather than the means of the given outcome period: standardized score = (outcome task score - mean\_baseline) / SD\_baseline. Thus, while baseline task scores were conventional z-scores, the six-month post-intervention standardized scores were not, in order to best inform the outcome measure and better facilitate comparison with baseline. The data below represent outcome values at 6 months. Like the baseline measure, this measure does not have a theoretical minimum or maximum, and higher scores indicate better performance.
Outcome measures
| Measure |
Adaptive CCT
n=57 Participants
Participants engaged in computerized cognitive training program involving games meant to enhance specific cognitive skills; the specific games presented and their level of challenge adapted to the prior performance of the participant.
|
Active Control
n=56 Participants
Participants were presented with the same CCT games but presentation was not dependent on prior performance and the challenge level did not change.
|
|---|---|---|
|
Executive Function/Attention
|
0.288 units on a scale
Standard Deviation 0.628
|
0.327 units on a scale
Standard Deviation 0.531
|
SECONDARY outcome
Timeframe: 6 months after the interventionPopulation: Siemens HbA1c machine was unavailable for 2 adaptive CCT and 1 active control participant.
A measure of glycemic control derived from blood sample. The data below represent outcome values at 6 months. Higher values represent poorer control of glycation.
Outcome measures
| Measure |
Adaptive CCT
n=55 Participants
Participants engaged in computerized cognitive training program involving games meant to enhance specific cognitive skills; the specific games presented and their level of challenge adapted to the prior performance of the participant.
|
Active Control
n=57 Participants
Participants were presented with the same CCT games but presentation was not dependent on prior performance and the challenge level did not change.
|
|---|---|---|
|
Hemoglobin A1c
|
7.58 percentage of hemoglobin glycation
Standard Deviation 1.68
|
7.50 percentage of hemoglobin glycation
Standard Deviation 1.40
|
SECONDARY outcome
Timeframe: 6 months after the interventionPopulation: Omron HEM-780 blood pressure device not available for 1 adaptive CCT and 2 active control participants.
A measure of the extent of pressure that blood is exerting against an individual's artery walls when the heart beats, assessed using a blood pressure cuff. Higher values indicate worse outcome. The data below represent outcome values at 6 months.
Outcome measures
| Measure |
Adaptive CCT
n=56 Participants
Participants engaged in computerized cognitive training program involving games meant to enhance specific cognitive skills; the specific games presented and their level of challenge adapted to the prior performance of the participant.
|
Active Control
n=56 Participants
Participants were presented with the same CCT games but presentation was not dependent on prior performance and the challenge level did not change.
|
|---|---|---|
|
Systolic Blood Pressure
|
129.82 mmHg
Standard Deviation 14.21
|
125.99 mmHg
Standard Deviation 16.13
|
SECONDARY outcome
Timeframe: assessed 6 months after interventionPopulation: Omron HEM-780 blood pressure device not available for 1 adaptive CCT and 2 active control participants.
A measure of the extent of pressure of the blood in the arteries when the heart is filling, assessed using a blood pressure cuff. Higher values indicate worse outcome. The data below represent outcome values at 6 months.
Outcome measures
| Measure |
Adaptive CCT
n=56 Participants
Participants engaged in computerized cognitive training program involving games meant to enhance specific cognitive skills; the specific games presented and their level of challenge adapted to the prior performance of the participant.
|
Active Control
n=56 Participants
Participants were presented with the same CCT games but presentation was not dependent on prior performance and the challenge level did not change.
|
|---|---|---|
|
Diastolic Blood Pressure
|
74.38 mmHg
Standard Deviation 10.45
|
69.77 mmHg
Standard Deviation 11.01
|
SECONDARY outcome
Timeframe: 6 months after the interventionPopulation: Test not administered to 5 participants (4 adaptive CCT and 1 active control).
The "Appointments - Delayed Recall" subtest of the Rivermead Behavioral Memory Test - Third Edition (RBMT - 3) is a test of prospective memory - remembering to do something in the future. The examinee was instructed to ask two questions when an alarm rings 25 minutes later. For each question, a score of 2 was given when a participant responded without requiring a prompt, 1 point when a prompt was needed and elicited a correct response, and 0 when there was no appropriate response despite prompting. Scores were summed and the total score ranges from 0 to 4. Higher scores indicate better performance. The data below represent outcome values at 6 months.
Outcome measures
| Measure |
Adaptive CCT
n=53 Participants
Participants engaged in computerized cognitive training program involving games meant to enhance specific cognitive skills; the specific games presented and their level of challenge adapted to the prior performance of the participant.
|
Active Control
n=57 Participants
Participants were presented with the same CCT games but presentation was not dependent on prior performance and the challenge level did not change.
|
|---|---|---|
|
Prospective Memory
|
3.47 score on a scale
Standard Deviation 0.77
|
3.40 score on a scale
Standard Deviation 0.90
|
Adverse Events
Computerized Cognitive Training (CCT)
Active Control
Serious adverse events
| Measure |
Computerized Cognitive Training (CCT)
n=90 participants at risk
Randomly selected subjects perform adaptive computerized cognitive training (CCT) program, CognifitTM\], involving a variety of computer games tailored to address their personal cognitive deficits. Cognifit is a web-accessed CCT program designed to improve cognition by targeting the user's weaker cognitive functions. The challenge at each session was adapted according to the user's prior performance and a cognitive score pertaining to the specific session was provided. Participants were instructed to have sessions three times per week for eight weeks, with at least one day of rest between sessions, for a total of 24 sessions. Each 20 minute session included a unique combination of three games accessing a variety of cognitive abilities.
|
Active Control
n=90 participants at risk
As for the CCT intervention group, these randomly selected subjects performed three games each session from the same set of Cognifit computer games over the same eight week schedule. The activity differed only in the program did not target training games nor adaptive in their level of challenge based on prior performance and no cognitive score was provided at the end of the session.
|
|---|---|---|
|
Gastrointestinal disorders
Surgery
|
0.00%
0/90 • The time period for each subject's participation was approximately 14.5 months. The initial baseline assessment (1 to 2 days) was followed by 8 weeks of adaptive CCT/active control activity. Participants were then assessed immediately after the intervention, and at 6 and 12 months post-intervention.
|
2.2%
2/90 • Number of events 2 • The time period for each subject's participation was approximately 14.5 months. The initial baseline assessment (1 to 2 days) was followed by 8 weeks of adaptive CCT/active control activity. Participants were then assessed immediately after the intervention, and at 6 and 12 months post-intervention.
|
|
Nervous system disorders
Stroke
|
1.1%
1/90 • Number of events 1 • The time period for each subject's participation was approximately 14.5 months. The initial baseline assessment (1 to 2 days) was followed by 8 weeks of adaptive CCT/active control activity. Participants were then assessed immediately after the intervention, and at 6 and 12 months post-intervention.
|
0.00%
0/90 • The time period for each subject's participation was approximately 14.5 months. The initial baseline assessment (1 to 2 days) was followed by 8 weeks of adaptive CCT/active control activity. Participants were then assessed immediately after the intervention, and at 6 and 12 months post-intervention.
|
|
Immune system disorders
Surgery
|
0.00%
0/90 • The time period for each subject's participation was approximately 14.5 months. The initial baseline assessment (1 to 2 days) was followed by 8 weeks of adaptive CCT/active control activity. Participants were then assessed immediately after the intervention, and at 6 and 12 months post-intervention.
|
1.1%
1/90 • Number of events 1 • The time period for each subject's participation was approximately 14.5 months. The initial baseline assessment (1 to 2 days) was followed by 8 weeks of adaptive CCT/active control activity. Participants were then assessed immediately after the intervention, and at 6 and 12 months post-intervention.
|
|
General disorders
Death
|
3.3%
3/90 • Number of events 3 • The time period for each subject's participation was approximately 14.5 months. The initial baseline assessment (1 to 2 days) was followed by 8 weeks of adaptive CCT/active control activity. Participants were then assessed immediately after the intervention, and at 6 and 12 months post-intervention.
|
3.3%
3/90 • Number of events 3 • The time period for each subject's participation was approximately 14.5 months. The initial baseline assessment (1 to 2 days) was followed by 8 weeks of adaptive CCT/active control activity. Participants were then assessed immediately after the intervention, and at 6 and 12 months post-intervention.
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jeremy Silverman
James J. Peters Veterans Affairs Medical Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place