Adaptation of a Cognitive Training Intervention for Diabetes Self-Management

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Adaptation of a Cognitive Training Intervention for Diabetes Self-Management

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03221452
• Other study ID #: 2016-08-0001
• Status: Active, not recruiting
• Phase: N/A
• First received: July 12, 2017
• Last updated: July 14, 2017
• Start date: September 2, 2016
• Est. completion date: October 2017

Study information

• Verified date: July 2017
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Function Abnormal
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Memory, Attention, and Problem Solving Skills for Diabetes
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Outcome

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