Clinical trial NCT02709629: CCT for Older Diabetic Adults
Official title: The Effects of Computerized Cognitive Training on Diabetic Elderly, Who Are at High Risk for Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Older Diabetic Persons Without Dementia
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Maccabi Healthcare Services, Israel
First posted: 2016-03-16
Enrollment: 85
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Eligibility criteria: Inclusion Criteria:

* Age 65 and over
* diagnosis of type 2 diabetes
* Health cover provided by Maccabi Health Services (MHS)
* Access to a home computer and internet connection
* Availability of a close relative/informant with regular and frequent contact with the participant (at least 10 hours per week), willing to respond to questionnaires at all time points.
* Fluency in Hebrew or English
* Living in the Tel-Aviv metropolitan area and surrounds

Exclusion Criteria:

* An existing diagnosis of dementia
* Prescription of dementia-related medication.
* Participation in a previous cognitive intervention study in the preceding year.
* Significant hearing/vision impairment likely to interfere with assessment and/or training
* Significant psychiatric/neurological or medical issues that may affect cognitive function.

Primary outcomes:
measure: Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks
timeFrame: 9 weeks
measure: Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire
timeFrame: 9 weeks
Secondary outcomes:
measure: Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 9 weeks
timeFrame: 9 weeks(immediately post-intervention)
measure: Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 35 weeks
timeFrame: 35 weeks (6 months follow up)
measure: Change in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks
timeFrame: 9 weeks
measure: Change in meta-memory (subjective ratings of memory performance), as reflect on the Meta-Memory Questionnaire, at 35 weeks
timeFrame: 35 weeks (6 months follow up)
measure: Change in self-reported mood-related symptoms on the geriatric depression scale at 9 weeks
timeFrame: 9 weeks
measure: Change in self-reported mood-related symptoms on the geriatric depression scale at 35 weeks
timeFrame: 35 weeks (6 months follow up)
measure: Change in informant-reported care-giving burden on the Zarit Burden Interview at 9 weeks
timeFrame: 9 weeks
measure: Change in informant-reported care-giving burden on the Zarit Burden Interview at 35 weeks
timeFrame: 35 weeks (6 months follow up)
measure: Change in blood sugar levels on a blood glucose test at 35 weeks
timeFrame: 35 weeks
measure: Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks
timeFrame: 35 weeks
measure: Change from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks
timeFrame: 35 weeks
Other outcomes:
Locations:
city: Ramat-Gan
country: Israel
facility: Joseph Sagol Neuroscience Center, Sheba Medical Center
state: Australian National University
Study officials:
References:
citation: Bahar-Fuchs A, Barendse MEA, Bloom R, Ravona-Springer R, Heymann A, Dabush H, Bar L, Slater-Barkan S, Rassovsky Y, Schnaider Beeri M. Computerized Cognitive Training for Older Adults at Higher Dementia Risk due to Diabetes: Findings From a Randomized Controlled Trial. J Gerontol A Biol Sci Med Sci. 2020 Mar 9;75(4):747-754. doi: 10.1093/gerona/glz073.