CCT for Diabetic Elderly Veterans (CCT_DEV)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by Department of Veterans Affairs
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT01736124
First received: November 8, 2012
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

Computerized cognitive training (CCT) is an intervention has improved cognitive functioning in the elderly with and without cognitive impairment. We 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.


Condition Intervention
Diabetes Mellitus, Type 2
Other: computerized cognitive training
Other: control games

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Computerized Cognitive Training to Improve Cognition in Diabetic Elderly Veterans

Resource links provided by NLM:


Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • diabetes self-management [ Time Frame: 6 months after the intervention ] [ Designated as safety issue: No ]
    We will use a self-report questionnaire. This is identified as one of two "primary outcome measures." Change from baseline line level will be used as the outcome.


Secondary Outcome Measures:
  • medication adherence [ Time Frame: 6months after the intervention ] [ Designated as safety issue: No ]
    an objective measure of medication use based on the CPRS. This is identified as one of two "primary outcome measures." Change from baseline line level will be used as the outcome.

  • memory [ Time Frame: 6 month after the intervention ] [ Designated as safety issue: No ]
    scores from neuropsychological tests of memory - word list and paragraph recall - will be standardized and summed for a memory score. Change from baseline line level will be used as the outcome.

  • executive function/attention [ Time Frame: 6 months after the intervention ] [ Designated as safety issue: No ]
    Scores from neuropsychological tests of memory - word list and paragraph recall - will be standardized and summed for a memory score. Change from baseline line level will be used as the outcome.

  • Hemoglobin A1c [ Time Frame: 6 months after the intervention ] [ Designated as safety issue: No ]
    a measure of glycemic control derived from blood sample. The measure will be change in HgA1c from baseline.

  • blood pressure [ Time Frame: 6 months after the intervention ] [ Designated as safety issue: No ]
    assessed using a blood pressure cuff, the measure will be change in blood pressure (systolic and diastolic) from baseline.


Estimated Enrollment: 400
Study Start Date: June 2014
Estimated Study Completion Date: November 2017
Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Computerized Cognitive Training (CCT)
Randomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits.
Other: computerized cognitive training
A variety of computer games tailored to address their personal cognitive deficits.
Active Comparator: Active control
Randomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills.
Other: control games
A variety of computer games that are engaging but not designed to enhance cognitive skills

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 our 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 times/week, for 20 minutes, during eight weeks. 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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01736124

Contacts
Contact: Jeremy Silverman, PhD (718) 584-9000 ext 5792 Jeremy.Silverman@va.gov

Locations
United States, Michigan
VA Ann Arbor Healthcare System, Ann Arbor, MI Not yet recruiting
Ann Arbor, Michigan, United States, 48105
Contact: Pearl Lee, MD    734-764-3419    pearllee@med.umich.edu   
United States, New York
James J. Peters VA Medical Center, Bronx, NY Not yet recruiting
Bronx, New York, United States, 10468
Contact: Jeremy Silverman, PhD    718-584-9000 ext 5792    Jeremy.Silverman@va.gov   
Principal Investigator: Jeremy Silverman, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: Jeremy Silverman, PhD Department of Veterans Affairs
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT01736124     History of Changes
Other Study ID Numbers: IIR 11-285
Study First Received: November 8, 2012
Last Updated: April 7, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
computerize cognitive training
dementia
cognitive decline
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 01, 2014