Diabetes mellitus (DM) has been associated with increased risk for cognitive decline and dementia in the elderly. Even minor cognitive impairments 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. It is imperative to find interventions to delay or prevent cognitive compromise in diabetic patients. 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. This study will provide the first evaluation of the effects of computerized cognitive training (CCT) on DM self-management behavior and clinical outcomes, in addition to cognition.
The objectives of this study are to (a) determine whether the CCT, relative to an active control, improves cognition (memory, 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; (b) demonstrate efficacy by improvement in behavioral outcomes 6 months after the intervention; (c) document the effects of CCT on the successive changes in cognition, DM related-behavior, and glycemic and blood pressure control; and (d) explore the impact of demographic and health characteristics, on the intervention effects.
400 non-demented DM elderly, 55 and older, with internet access and without major visual or auditory impairment, will be enrolled from the James J. Peters and Ann Arbor VAMCs. Participants will be randomized to CCT or games intervention and perform the program every other day for 24 total sessions. The proposed CCT program, Personal Coach from Cognifit, is designed to improve cognition of elderly persons by targeting their weak cognitive functions. The games intervention, produced by the same company, includes sessions identical to the first two and last two of the CCT program. 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, cognitive function, DM self-management, and blood pressure will be assessed; blood will be drawn for HbA1c measurement. 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.
In the past year, we were approved for a no cost extension to extend recruitment time. In addition, we were approved to redirect funds to purchase laptop computers with MiFi that could be loaned to Veterans who were otherwise eligible but for the absence of computer/internet access. Recruitment was fully terminated at the end of January, 2018. Thus, data collection for the study will continue through January 2019, when the final subjects will have their twelve-month assessments. At that time, the blind can be removed and data analysis pertaining to the intervention can be initiated.
Diabetic in elderly Veterans is increasingly seen at the VA. As the number of Veterans with cognitive impairment increases, so will the overall cost of care for the VA. Risk for cognitive compromise is increased with diabetes and cognitive deficits likely contribute to deficits in disease management by the patient. If CCT is found to be efficacious, the findings of the study will be applicable to prevention of cognitive decline and dementia among elderly Veterans with diabetes, by providing a basis for the use of CCT in therapeutic efforts to minimize diabetes-related complications. Further, this study will focus on medication adherence and diabetes self-management. The study will also elucidate characteristics facilitating the effects of CCT on diabetes related behavioral and clinical outcomes. Identifying such characteristics will likely lead to better targeted implementation of CCT as a service for Veterans at highest risk for cognitive compromise.
None at this time.
Aging, Older Veterans' Health and Care, Diabetes and Related Disorders
Treatment - Efficacy/Effectiveness Clinical Trial
Adherence, Diabetes, Outcomes - Patient