CCT for Older Diabetic Adults

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes, Older Diabetic Persons Without Dementia

Intervention / Treatment
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* Behavioral: Individualized and adaptive computerized cognitive training
* Behavioral: Active control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized and adaptive computerised cognitive training<br>Training in this group is individualized using a computer algorithm which assigns tasks (from a pool of 33 training tasks) on the basis of cognitive strengths and weaknesses as determined by the training program. In addition, task difficulty is adaptive and responsive to performance level. Participants are able to see feedback on their progress each training session in the form of a session-score. A range of behavior change techniques are used throughout the training period (delivered via scheduled monitoring phone calls, and email contact with participants) to support the compliance and adherence of participants. These include a range of motivation and confidence building strategies, based on a theoretical framework. Participants are required to train for approx. 30 min., 3 times per week, for 8 weeks. | Behavioral: Individualized and adaptive computerized cognitive training<br> <br> |
| Active Comparator: Active control<br>Training in this group is generic, and tasks (from the same pool of 33 training tasks) are randomly selected by the training program. In addition, task difficulty is fixed, such that irrespective of performance, each time a participant is presented with a given task, the level of difficulty returns to the basic level. Participants in this arm do not receive feedback on their progress at the end of each training session. The same protocol of behavior change techniques is used in this intervention arm. Participants are also required to train for approx. 30 min., 3 times per week, for 8 weeks. | Behavioral: Active control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks |  | 9 weeks | 
| Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire |  | 9 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 9 weeks |  | 9 weeks(immediately post-intervention) | 
| Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 35 weeks |  | 35 weeks (6 months follow up) | 
| Change in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks |  | 9 weeks | 
| Change in meta-memory (subjective ratings of memory performance), as reflect on the Meta-Memory Questionnaire, at 35 weeks |  | 35 weeks (6 months follow up) | 
| Change in self-reported mood-related symptoms on the geriatric depression scale at 9 weeks |  | 9 weeks | 
| Change in self-reported mood-related symptoms on the geriatric depression scale at 35 weeks |  | 35 weeks (6 months follow up) | 
| Change in informant-reported care-giving burden on the Zarit Burden Interview at 9 weeks |  | 9 weeks | 
| Change in informant-reported care-giving burden on the Zarit Burden Interview at 35 weeks |  | 35 weeks (6 months follow up) | 
| Change in blood sugar levels on a blood glucose test at 35 weeks |  | 35 weeks | 
| Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks |  | 35 weeks | 
| Change from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks |  | 35 weeks |