Computerized Cognitive Training for Diabetic Elderly Veterans
CCT_DEV
1 other identifier
interventional
199
1 country
1
Brief Summary
Computerized cognitive training (CCT) is an intervention has improved cognitive functioning in the elderly with and without cognitive impairment. The investigators will study the effect of a CCT program over an active control, "classic" computerized games. The outcomes will be memory and executive functions/attention, diabetes elf-management and adherence to medications, and glycemic and blood pressure control. Non-demented elderly Veterans with diabetes mellitus, who are at high risk for cognitive impairment, will be from the James J. Peters, Bronx, NY and Ann Arbor, MI VAMCs. This novel potential service fits the portfolio of the Quality Enhancement Research Initiative for Diabetes Mellitus (QUERI-DM) for which the Ann Arbor VAMC is a primary center. If successful, the VA National Center for Prevention and MyHeatheVet will collaborate in disseminating results to encourage implementation throughout the VA
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Apr 2015
Longer than P75 for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 8, 2012
CompletedFirst Posted
Study publicly available on registry
November 29, 2012
CompletedStudy Start
First participant enrolled
April 7, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2018
CompletedResults Posted
Study results publicly available
February 23, 2021
CompletedJuly 27, 2023
July 1, 2023
2.8 years
November 8, 2012
September 14, 2020
July 19, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Diabetes Self-management
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.
6 months after the intervention
Secondary Outcomes (7)
Medication Adherence
12 months post-intervention
Memory
6 month after the intervention
Executive Function/Attention
6 months after the intervention
Hemoglobin A1c
6 months after the intervention
Systolic Blood Pressure
6 months after the intervention
- +2 more secondary outcomes
Study Arms (2)
Computerized Cognitive Training (CCT)
EXPERIMENTALRandomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits.
Active control
ACTIVE COMPARATORRandomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills.
Interventions
A variety of computer games tailored to address their personal cognitive deficits.
A variety of computer games that are engaging but not designed to enhance cognitive skills
Eligibility Criteria
You may qualify if:
- years old or above
- A diagnosis of type 2 diabetes
- Access to computer and internet
- Has an informant
- Self-management score 18 or below
You may not qualify if:
- Dementia or prescribed AD medications
- Major medical, psychiatric, or neurological conditions that affect cognitive performance
- Severe impairment of vision, hearing or fine motor control necessary for computer operation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, 10468-3904, United States
Related Publications (2)
Karran M, Guerrero-Berroa E, Schmeidler J, Lee PG, Alexander N, Nabozny M, West RK, Beeri MS, Sano M, Silverman JM. Recruitment of Older Veterans with Diabetes Risk for Alzheimer's Disease for a Randomized Clinical Trial of Computerized Cognitive Training. J Alzheimers Dis. 2019;69(2):401-411. doi: 10.3233/JAD-180952.
PMID: 31006684BACKGROUNDSilverman JM, Schmeidler J, Lee PG, Alexander NB, Beeri MS, Guerrero-Berroa E, West RK, Sano M, Nabozny M, Rodriguez Alvarez C. Associations of hemoglobin A1c with cognition reduced for long diabetes duration. Alzheimers Dement (N Y). 2019 Dec 11;5:926-932. doi: 10.1016/j.trci.2019.11.009. eCollection 2019.
PMID: 31890856BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Attrition of subjects was greater among minorities, Bronx site, CDR=0.5 ("questionable dementia"), lower (worse) MMSE and worse health literacy. Rates of attrition by these and all other covariates measured did not differ between intervention groups.
Results Point of Contact
- Title
- Dr. Jeremy Silverman
- Organization
- James J. Peters Veterans Affairs Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Jeremy Silverman, PhD
James J. Peters Veterans Affairs Medical Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 8, 2012
First Posted
November 29, 2012
Study Start
April 7, 2015
Primary Completion
January 31, 2018
Study Completion
January 31, 2018
Last Updated
July 27, 2023
Results First Posted
February 23, 2021
Record last verified: 2023-07
Data Sharing
- IPD Sharing
- Will not share