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Diabetes Mellitus, Type 2Phase 4CCT_DEVNCT01736124

Computerized Cognitive Training for Diabetic Elderly Veterans

A Phase 4 study testing computerized cognitive training in people with Diabetes Mellitus, Type 2, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 55 to 99 years
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
computerized cognitive training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
199 participants
Where
1 siteUnited States
Study dates
7 Apr 2015to 31 Jan 2018
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 55 years old or above
  • A diagnosis of type 2 diabetes
  • Access to computer and internet
  • Has an informant
  • Self-management score 18 or below

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • James J. Peters VA Medical Center, Bronx, NY

    The Bronx, New York, 10468-3904

Other trials in United States

About this study

Official title: Computerized Cognitive Training to Improve Cognition in Diabetic Elderly Veterans

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

Read the detailed description

Project Background: Diabetes mellitus (DM) has consistently been associated with increased risk for cognitive decline, mild cognitive impairment, and dementia in the elderly. Even minor cognitive impairments in nondemented individuals dramatically affect disease self-management. This, in turn, is associated with poor glycemic and blood pressure control in diabetes, which by themselves increase the risk of dementia, provoking a reinforcing cycle of disease. Thus, it is imperative to find interventions to delay or prevent cognitive compromise in diabetic patients, that can be relatively easily and rapidly implemented, and that are not cost prohibitive. This is especially true in the VA, in view of the high incidence of both diabetes and dementia in the growing population of elderly Veterans.

Epidemiologic evidence suggests modifiable life-style factors, including cognitive activity, may prevent or delay the onset of cognitive decline. Computerized cognitive training (CCT) is an intervention that has shown promising results in the improvement of cognitive functioning, more consistently in non-demented elderly, with additional benefits from booster training sessions. To date, studies of CCT have typically only examined cognitive outcomes, and only shortly after the intervention. The proposed CCT program, Personal Coach from Cognifit, is designed to improve cognition of elderly persons by targeting their weak cognitive functions, using a personally tailored training plan. The proposed study will provide the first evaluation of the effects of CCT on DM self-management behavior and clinical outcomes, in addition to cognition.

Project Objectives: Aim 1A: To determine whether the CCT, relative to the active control games program, improves cognition (memory and executive functions/attention), DM-related behavior (DM self-management and medication adherence), and clinical outcomes (glycemic and blood pressure control), 6 and 12 months after the intervention. Aim 1B: To demonstrate efficacy by improvement in behavioral outcomes (DM self-management and medication adherence) 6 months after the intervention. Aim 2: To document the effects of CCT on the successive changes in memory and executive functions/attention, DM self-management and medication adherence, and glycemic and blood pressure control. Aim 3: To explore the impact of demographic (age, education, ethnicity, site) and health (ADL/IADL, health literacy, depression, dementia family history, lifestyle factors) characteristics, on the intervention effects.

Project Methods: Non-demented DM elderly from the James J. Peters (Bronx, NY) and Ann Arbor (MI) VAMCs will be randomized to CCT or games intervention and perform the respective program 3 days per week (every other day), for 20 minutes, for 24 total sessions. Four months after the intervention, subjects will receive a 1-week booster training. Subjects will be assessed at baseline; and immediately, 6 months, and 12 months after the intervention. At each time point, assessments will be cognitive function, DM self-management, and blood pressure; blood will be drawn for HbA1c measurement. VA records will be used to monitor medication adherence. Longitudinal mixed model analyses will assess the effects of the intervention on change in outcomes over time. Path analyses will evaluate the inter-relationships among changes in cognition, DM self-management, and clinical outcomes for each intervention at 6 and 12 months.

Being tested
computerized cognitive training, control games
Keywords
computerize cognitive training, dementia, cognitive decline, Diabetes Mellitus, Type 2
Medical subject headings
Diabetes Mellitus, Type 2, Dementia, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • computerized cognitive trainingOther

    A variety of computer games tailored to address their personal cognitive deficits.

  • control gamesOther

    A variety of computer games that are engaging but not designed to enhance cognitive skills

Study groups in NCT01736124
Study groupRoleWhat they receive
Computerized Cognitive Training (CCT)ExperimentalRandomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits.
Receives: Other: computerized cognitive training
Active controlActive comparatorRandomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills.
Receives: Other: control games

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 6 months after the intervention

Secondary outcomes (7)
  1. Medication Adherence

    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.

    Measured: 12 months post-intervention

  2. Memory

    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.

    Measured: 6 month after the intervention

  3. Executive Function/Attention

    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.

    Measured: 6 months after the intervention

  4. Hemoglobin A1c

    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.

    Measured: 6 months after the intervention

  5. Systolic Blood Pressure

    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.

    Measured: 6 months after the intervention

  6. Diastolic Blood Pressure

    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.

    Measured: assessed 6 months after intervention

  7. Prospective Memory

    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.

    Measured: 6 months after the intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2012 (estimated)
  2. Study start7 Apr 2015
  3. Primary completion31 Jan 2018
  4. Study completion31 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
199 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01736124
Sponsor's protocol ID
IIR 11-285
Acronym
CCT_DEV
Status last verified
Jul 2023
First submitted
8 Nov 2012
Last updated
27 Jul 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 31006684
  • Silverman 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.

    PubMed 31890856

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing computerized cognitive training in people with Diabetes Mellitus, Type 2, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Diabetes Self-management (time frame: 6 months after the intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01736124, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.

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CCT_DEV Clinical Trial NCT01736124 | AzTrials