Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Adaptation of a Cognitive Training Intervention for Diabetes Self-Management
Verified date | July 2017 |
Source | University of Texas at Austin |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 29 |
Est. completion date | October 2017 |
Est. primary completion date | June 10, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 70 Years |
Eligibility |
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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University of Texas at Austin |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Diabetes Self-Care Activities | 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 | |
Secondary | General Self-Efficacy Scale | 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 | |
Secondary | Multifactorial Memory Questionnaire | 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 | |
Secondary | Change in executive function | 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 | |
Secondary | Center for Epidemiologic Studies Depression Scale | 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 |
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