Adaptation of a Cognitive Training Intervention for Diabetes Self-Management

NCT03221452 | Unknown

• 1 other identifier: 2016-08-0001
• Study Type: interventional
• Target: 29
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cognitive Function Abnormal; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• General Self-Efficacy Scale

  Baseline and immediately post-intervention

• Multifactorial Memory Questionnaire

  Baseline and immediately post-intervention

• Change in executive function

  Baseline and immediately post-intervention

• Center for Epidemiologic Studies Depression Scale

  Baseline and immediately post-intervention

Study Arms (1)

Intervention

OTHER

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.

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

Interventions

Memory, Attention, and Problem Solving Skills for Diabetes BEHAVIORAL

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.

Intervention

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• limitations that preclude study activities
• have been diagnosed with dementia or disorders that can affect cognition such as depression
• type 1 diabetes

Sponsors & Collaborators

• University of Texas at Austin: lead

MeSH Terms

Conditions

Cognition Disorders; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Neurocognitive Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Heather E Cuevas, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group study for intervention feasibility

Study Record Dates

• First Submitted: July 12, 2017
• First Posted: July 18, 2017
• Study Start: September 2, 2016
• Primary Completion: June 10, 2017
• Study Completion: October 1, 2017
• Last Updated: July 18, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share