Computerized Cognitive Training for Diabetic Elderly Veterans
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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
    

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.
    

Intervention name(s): computerized cognitive training; control games
Intervention type(s): Other; Other
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: computerize cognitive training; dementia; cognitive decline; Diabetes Mellitus, Type 2