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Clinical Trials/NCT03221452
NCT03221452
Unknown
Not Applicable

Adaptation of a Cognitive Training Intervention for Diabetes Self-Management

University of Texas at Austin0 sites29 target enrollmentSeptember 2, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cognitive Function Abnormal
Sponsor
University of Texas at Austin
Enrollment
29
Primary Endpoint
Change in Diabetes Self-Care Activities
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2, 2016
End Date
October 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Change in Diabetes Self-Care Activities

Time Frame: 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.

Secondary Outcomes

  • Change in executive function(Baseline and immediately post-intervention)
  • General Self-Efficacy Scale(Baseline and immediately post-intervention)
  • Multifactorial Memory Questionnaire(Baseline and immediately post-intervention)
  • Center for Epidemiologic Studies Depression Scale(Baseline and immediately post-intervention)

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