The Effects of Computerized Cognitive Training on Diabetic Elderly, Who Are at High Risk for Dementia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Individualized and adaptive computerized cognitive training (Behavioral)
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.
干预措施: Active control (Behavioral)
结局指标
主要结局
Change from baseline in global cognition as reflected in a composite cognitive score at 9 weeks
时间窗: 9 weeks
Change from baseline in diabetes self management as reflected in the diabetes self-management questionnaire
时间窗: 9 weeks
次要结局
- Change from baseline in global cognition as reflected in a composite cognitive score at 35 weeks(35 weeks)
- 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 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)
研究者
Dr. Alex Bahar-Fuchs
Dr Alex Bahar-Fuchs
Sheba Medical Center