CCT for Older Diabetic Adults
- Conditions
- DiabetesOlder Diabetic Persons Without Dementia
- Registration Number
- NCT02709629
- Lead Sponsor
- Sheba Medical Center
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 85
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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 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 in meta-memory (subjective ratings of memory performance) as reflect on the Meta-Memory Questionnaire at 9 weeks 9 weeks Change in self-reported mood-related symptoms on the geriatric depression scale 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 from baseline in diabetes self-management as reflected in scores on the diabetes self-management questionnaire at 35 weeks 35 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
Trial Locations
- Locations (1)
Joseph Sagol Neuroscience Center, Sheba Medical Center
🇮🇱Ramat-Gan, Australian National University, Israel
Joseph Sagol Neuroscience Center, Sheba Medical Center🇮🇱Ramat-Gan, Australian National University, Israel