Cognitive Training for Diabetes Self-Management
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 2
- 主要终点
- Change in A1C at Week 22
研究概览
简要总结
The overall objective of this study is to determine the effects of a comprehensive cognitive rehabilitation intervention on biological, cognitive, and diabetes self-management outcomes.
详细描述
Aim 1: Test the efficacy of the MAPSS-DM intervention for improving cognitive function, A1C, and DM-SM. Based on preliminary data, the working hypothesis is that compared with the control group, persons who receive the intervention will have improved memory, executive function, and perceived cognitive function, greater use of cognitive strategies, and improved DM-SM immediately post-intervention and at three and six-months post-intervention.
Aim 2: To explore changes in glycemic variability and their association with changes in cognitive function. The working hypothesis here is that MAPSS-DM participants will exhibit less glycemic variability post-intervention as compared with baseline and glycemic variability will mediate improvements in cognitive test performance.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The intervention will be delivered by a research assistant and outcome data collection will be done by two other research assistants
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 50 years old or greater
- •T2DM diagnosis for 2 years
- •access to phone and Internet
- •Score of ≥10 on the Perceived Deficits Questionnaire (PDQ)
- •A1C of >7%.
排除标准
- •a diagnosis of dementia/head injury
- •score of >5 on the Mini-Cog
- •inability to speak English, and T1DM diagnosis
结局指标
主要结局
Change in A1C at Week 22
时间窗: Baseline and week 22
Measure of difference in average glucose over 22 weeks; A1C is one time point that measures a 3 month average glucose (e.g. and A1C of 7% = approximately a 154mg/dl average glucose for the past 3 months) therefore it can be measured at baseline and week 22 and still reflect a 3 month average at both those time points.
Change in Diabetes Self-management Adherence at Week 22
时间窗: Baseline and week 22
Summary of Diabetes Self-Care Activities: 8 items; Brief assessment of diabetes related psychosocial self-efficacy. Responses are made on a 5-point scale (1 = strongly disagree to 5 = strongly agree) to items such as "I believe that I am able to turn my diabetes goals into a workable plan." Higher scores indicate higher levels of self-management adherence.
Change in Glucose Variability at Week 22
时间窗: Baseline and week 22
Difference in the standard deviation of glucose readings from baseline and week 22
Change From Baseline to Week 22 in the Number of Correct Responses in 90 Seconds on the Symbol Digit Modalities Test
时间窗: Baseline and week 22
Symbol Digit Modalities Test: Participants are given a series of symbols and digits and instructed to verbalize the digit associated with each symbol. The number of correct responses in 90 sec constitutes the score, and higher scores reflect better cognitive function.
次要结局
- Change in Perceived Cognitive Function at Week 22(Baseline and week 22)