- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02709629
CCT for Older Diabetic Adults
The Effects of Computerized Cognitive Training on Diabetic Elderly, Who Are at High Risk for Dementia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Australian National University
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Ramat-Gan, Australian National University, Israel, 0200
- Joseph Sagol Neuroscience center, Sheba Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Individualized and adaptive computerised cognitive training
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.
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Active Comparator: Active control
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks
Time Frame: 9 weeks
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9 weeks
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Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire
Time Frame: 9 weeks
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9 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 9 weeks
Time Frame: 9 weeks(immediately post-intervention)
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9 weeks(immediately post-intervention)
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Change in domain-specific cognitive abilities (memory, non-memory) measured by composite scores from the neuropsychological test battery, at 35 weeks
Time Frame: 35 weeks (6 months follow up)
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35 weeks (6 months follow up)
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Change in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks
Time Frame: 9 weeks
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9 weeks
|
Change in meta-memory (subjective ratings of memory performance), as reflect on the Meta-Memory Questionnaire, at 35 weeks
Time Frame: 35 weeks (6 months follow up)
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35 weeks (6 months follow up)
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Change in self-reported mood-related symptoms on the geriatric depression scale at 9 weeks
Time Frame: 9 weeks
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9 weeks
|
Change in self-reported mood-related symptoms on the geriatric depression scale at 35 weeks
Time Frame: 35 weeks (6 months follow up)
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35 weeks (6 months follow up)
|
Change in informant-reported care-giving burden on the Zarit Burden Interview at 9 weeks
Time Frame: 9 weeks
|
9 weeks
|
Change in informant-reported care-giving burden on the Zarit Burden Interview at 35 weeks
Time Frame: 35 weeks (6 months follow up)
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35 weeks (6 months follow up)
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Change in blood sugar levels on a blood glucose test at 35 weeks
Time Frame: 35 weeks
|
35 weeks
|
Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks
Time Frame: 35 weeks
|
35 weeks
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Change from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks
Time Frame: 35 weeks
|
35 weeks
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0573-13-SMC
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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