NCT02709629

CCT for Older Diabetic Adults

The Effects of Computerized Cognitive Training on Diabetic Elderly, Who Are at High Risk for Dementia

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Sheba Medical Center · Other Government
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The current study examines the efficiency of a home-based computerized cognitive training (CT) intervention targeting older adults with diabetes.The primary aim of the study is to evaluate the effects of CCT on cognitive and disease management in non-demented older diabetes adults. Investigators will also evaluate the effect of the intervention on a range of secondary outcomes, including mood, caregiver burden, self-efficacy, and for a small sub-sample, on brain activity as reflected in changes in task-related blood-flow on fMRI.

Detailed description

Evidence suggests a link between diabetes-related processes and increased risk of cognitive decline and dementia in older adults. Optimal disease self-management may be key in the prevention of cognitive decline among older diabetic patients, but this may be compromised due to sub-clinical cognitive impairment. In the current study, 120 community-dwelling, non-demented participants aged 65 and over, with a diagnosis of Type 2 diabetes will be randomly assigned either to an 8-week, home-based individually-tailored CCT program with adaptive difficulty level, and regular performance feedback, or to an 8-week, home-based active control (AC) condition, involving training on a generic CCT program with fixed difficulty level and without performance feedback. Both intervention groups also include a range of theory-informed behavior change techniques (BCTs), including self-efficacy management, self-monitoring and goal-setting in order to enhance treatment fidelity, and to maximize treatment compliance and adherence. In both groups, participants train approx. 30 min. per day, 3 times per-week for 8-weeks. Participants undergo a comprehensive evaluation of all outcomes at baseline, immediately after the intervention, and at a 6-month follow-up, with 1-week booster training completed 3 months from completion of the intervention.

Conditions

• Diabetes
• Older Diabetic Persons Without Dementia

Interventions

Type	Name	Description
BEHAVIORAL	Individualized and adaptive computerized cognitive training
BEHAVIORAL	Active control

Timeline

• Start date: 2015-08-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2016-03-16
• Last updated: 2018-04-19

Locations

1 site across 1 country: Israel