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Adaptation of a Cognitive Training Intervention for Diabetes Self-Management

Adaptation of a Cognitive Training Intervention for Diabetes Self-Management

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03221452
Enrollment
29
Registered
2017-07-18
Start date
2016-09-02
Completion date
2017-10-31
Last updated
2017-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Function Abnormal, Diabetes Mellitus, Type 2

Brief summary

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.

Detailed description

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.

Interventions

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.

Sponsors

University of Texas at Austin
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Intervention model description

Single group study for intervention feasibility

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Diabetes Self-Care ActivitiesBaseline and immediately post-interventionSummary 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.

Secondary

MeasureTime frameDescription
General Self-Efficacy ScaleBaseline and immediately post-intervention10 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.
Multifactorial Memory QuestionnaireBaseline and immediately post-intervention57 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).
Change in executive functionBaseline and immediately post-interventionBarkley 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).
Center for Epidemiologic Studies Depression ScaleBaseline and immediately post-intervention20 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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026