CCT for Diabetic Elderly Veterans (CCT_DEV)
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|ClinicalTrials.gov Identifier: NCT01736124|
Recruitment Status : Recruiting
First Posted : November 29, 2012
Last Update Posted : November 1, 2017
|Condition or disease||Intervention/treatment|
|Diabetes Mellitus, Type 2||Other: computerized cognitive training Other: control games|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Computerized Cognitive Training to Improve Cognition in Diabetic Elderly Veterans|
|Actual Study Start Date :||April 7, 2015|
|Estimated Primary Completion Date :||March 31, 2019|
|Estimated Study Completion Date :||March 31, 2019|
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
- diabetes self-management [ Time Frame: 6 months after the intervention ]The investigators 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.
- medication adherence [ Time Frame: 6 months after the intervention ]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 ]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 ]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 ]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 ]assessed using a blood pressure cuff, the measure will be change in blood pressure (systolic and diastolic) from baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01736124
|Contact: Jeremy Silverman, PhD||(718) 584-9000 ext 6007||Jeremy.Silverman@va.gov|
|Contact: Martha A Karran, BA||(718) 584-9000 ext firstname.lastname@example.org|
|United States, Michigan|
|VA Ann Arbor Healthcare System, Ann Arbor, MI||Recruiting|
|Ann Arbor, Michigan, United States, 48105|
|Contact: Pearl G Lee, MD 734-769-7100 Pearl.Lee2@va.gov|
|Contact: Martina Nabozny (734) 763-4457|
|Sub-Investigator: Pearl G. Lee, MD|
|United States, New York|
|James J. Peters VA Medical Center, Bronx, NY||Recruiting|
|The Bronx, New York, United States, 10468|
|Contact: Jeremy Silverman, PhD 718-584-9000 ext 6007 Jeremy.Silverman@va.gov|
|Contact: Martha A Karran, BA (718) 584-9000 ext 3841 email@example.com|
|Principal Investigator: Jeremy Silverman, PhD|
|Principal Investigator:||Jeremy Silverman, PhD||VA Office of Research and Development|