Adaptation of a Cognitive Training Intervention for Diabetes Self-Management
2017年7月14日 更新者：University of Texas at Austin
The aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with T2DM by using current literature and interview data from 10 participants with T2DM and (2) to conduct a feasibility study of the adapted intervention with 20 participants with T2DM.
The intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies.
Participants will also use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health.
研究概览
详细说明
Type 2 diabetes mellitus (T2DM) increases the risk for cognitive impairment and doubles the rate of cognitive decline after diabetes is diagnosed.
In turn, the presence of cognitive dysfunction can make diabetes self-management more difficult.
Few interventions have attempted to focus on cognitive function in the context of diabetes and none, to date have tested an intervention to improve cognition in order to improve diabetes self-management.
Therefore the aims of this project are: (1) to refine an existing cognitive rehabilitation intervention and tailor it for persons with T2DM by using current literature and interview data from 10 participants with T2DM and (2) to conduct a feasibility study of the adapted intervention with 20 participants with T2DM.
The intervention consists of 8 weekly group educational sessions to teach compensatory cognitive strategies.
Additionally, participants will use a web-based, game-like program to build on the didactic information and practice activities to improve cognitive health.
The project will provide baseline data for further research on diabetes self-management in the context of cognitive dysfunction.
研究类型
介入性
注册 (实际的)
29
阶段
- 不适用
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
40年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age 40 to 70
- Have been diagnosed with type 2 diabetes for at least 2 years
- Score of at least 10 on the Perceived Deficits Questionnaire
- Read and write in English
- Have access to transportation and telephone and Internet services
Exclusion Criteria:
- limitations that preclude study activities
- have been diagnosed with dementia or disorders that can affect cognition such as depression
- type 1 diabetes
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Intervention
The intervention includes 4 every other week, 2-hour educational sessions to teach compensatory strategies along with skill development and training.
Educational sessions will include content on common cognitive problems experienced by people with T2DM and discussion of compensatory strategies to improve cognitive skills as well as content on behaviors and lifestyle strategies to maintain cognitive functioning.
Each participant will use the online training program (BrainHQ/Posit Science) for a minimum of 45 minutes 3 times a week and to record practice times and dates.
Tasks in the computer training are arranged so that as the user moves forward, the tasks become more challenging.
Each task is in a game-like format.
|
Classes will include: (1) information on diabetes self-management including glucose self-monitoring and medication management; (2) assessment of cognitive problems; (3) resources and barriers to self-management; and (4) lifestyle changes to maximize cognitive health.
Participants will also practice those skills with online computer games.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Diabetes Self-Care Activities
大体时间：Baseline and immediately post-intervention
|
Summary of Diabetes Self-Care Activities Questionnaire; 18 items; Participants answer questions regarding how many days in the last week have they performed a certain aspect of diabetes self-management behaviors such as diet, smoking, and physical activity.
|
Baseline and immediately post-intervention
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
General Self-Efficacy Scale
大体时间：Baseline and immediately post-intervention
|
10 items; confidence in ability to influence outcomes.
Responses are made on a 4-point scale (1 = not true at all, 2= hardly true, 3 = moderately true, 4= exactly true) to items such as "I can always manage to solve difficult problems If I try hard enough."
|
Baseline and immediately post-intervention
|
|
Multifactorial Memory Questionnaire
大体时间：Baseline and immediately post-intervention
|
57 items; assesses contentment with one's memory, subjective memory capability, and use of memory aids.
Participants rate their level of agreement with each item on a 5-point scale (strongly agree = 1, agree = 2, undecided = 3, disagree = 4, strongly disagree = 5) for the Contentment subscale; The Ability subscale asks participants to indicate the frequency with which each memory failure has occurred in the past 2 weeks on a 5-point scale (all the time = 1, often =2, sometimes = 3, rarely =4, never =5); The third subscale, Strategy, asks participants to rate the frequency of use of certain memory strategies on a 5-point scale (never =1, rarely =2, sometimes =3, often =4, all the time =5).
|
Baseline and immediately post-intervention
|
|
Change in executive function
大体时间：Baseline and immediately post-intervention
|
Barkley Deficits in Executive Functioning Scale - Short Form Scale; 20 items assessing the frequency at which participants have exhibited certain behaviors in specific executive functioning areas over the past 6 months.
The areas include: self-management to time, self-organization/problem-solving, self-restraint, self-motivation, and self-regulation of emotion.
Items are measured using a 4-point Likert scale, ranging from never or rarely (1) to very often (4).
|
Baseline and immediately post-intervention
|
|
Center for Epidemiologic Studies Depression Scale
大体时间：Baseline and immediately post-intervention
|
20 items; measurement of depressive symptoms.
Participants indicate responses on a 4-point item scale from rarely/none of the time to most/all of the time in 8 health dimensions: role limitations due to physical problems, social functioning, physical functioning, bodily pain, general mental health, role limitations due to emotional problems, vitality, and general health perceptions.
|
Baseline and immediately post-intervention
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Heather E Cuevas, PhD、The University of Texas at Austin
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年9月2日
初级完成 (实际的)
2017年6月10日
研究完成 (预期的)
2017年10月1日
研究注册日期
首次提交
2017年7月12日
首先提交符合 QC 标准的
2017年7月14日
首次发布 (实际的)
2017年7月18日
研究记录更新
最后更新发布 (实际的)
2017年7月18日
上次提交的符合 QC 标准的更新
2017年7月14日
最后验证
2017年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.