Clinical trial NCT03221452: Adaptation of a Cognitive Training Intervention for Diabetes Self-Management
Official title: Adaptation of a Cognitive Training Intervention for Diabetes Self-Management
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cognitive Function Abnormal
Diabetes Mellitus, Type 2
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2017-07-18
Enrollment: 29
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single group study for intervention feasibility
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Change in Diabetes Self-Care Activities
timeFrame: Baseline and immediately post-intervention
Secondary outcomes:
measure: General Self-Efficacy Scale
timeFrame: Baseline and immediately post-intervention
measure: Multifactorial Memory Questionnaire
timeFrame: Baseline and immediately post-intervention
measure: Change in executive function
timeFrame: Baseline and immediately post-intervention
measure: Center for Epidemiologic Studies Depression Scale
timeFrame: Baseline and immediately post-intervention
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas at Austin
name: Heather E Cuevas, PhD
role: PRINCIPAL_INVESTIGATOR
References: