Computerized Cognitive Training for Diabetic Elderly Veterans

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-07

Study Completion Date

2018-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

CCT for Older Diabetic Adults

NCT02709629

Diabetes Older Diabetic Persons Without Dementia

COMPLETED NA

Efficacy of Computer-Based Cognitive Game Training for Healthy Elderly

NCT03940079

Aging Cognitive Function

COMPLETED NA

Computerized Cognitive Training for the Elderly

NCT02632604

Aging

UNKNOWN NA

Assessing and Improving the Durability of Compensatory Cognitive Training for Older Veterans

NCT05770479

Mild Cognitive Impairment

ENROLLING_BY_INVITATION NA

Tablet-based Cognitive Training

NCT04452864

Alzheimer Disease Dementia Mild Cognitive Impairment

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Computerized Cognitive Training (CCT)

Randomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits.

Group Type EXPERIMENTAL

computerized cognitive training

Intervention Type OTHER

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

Active control

Randomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills.

Group Type ACTIVE_COMPARATOR

control games

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.