Clinical Trials Directory

Trials / Completed

CompletedNCT04831775

Cognitive Training for Diabetes Self-Management

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
95 (actual)
Sponsor
University of Texas at Austin · Academic / Other
Sex
All
Age
50 Years
Healthy volunteers
Accepted

Summary

The overall objective of this study is to determine the effects of a comprehensive cognitive rehabilitation intervention on biological, cognitive, and diabetes self-management outcomes.

Detailed description

Aim 1: Test the efficacy of the MAPSS-DM intervention for improving cognitive function, A1C, and DM-SM. Based on preliminary data, the working hypothesis is that compared with the control group, persons who receive the intervention will have improved memory, executive function, and perceived cognitive function, greater use of cognitive strategies, and improved DM-SM immediately post-intervention and at three and six-months post-intervention. Aim 2: To explore changes in glycemic variability and their association with changes in cognitive function. The working hypothesis here is that MAPSS-DM participants will exhibit less glycemic variability post-intervention as compared with baseline and glycemic variability will mediate improvements in cognitive test performance.

Conditions

Interventions

TypeNameDescription
BEHAVIORALMemory, Attention, and Problem Solving Skills for DiabetesThe intervention is composed of 4 small-group webinar classes and home-based individual online cognitive skills practice and will be held over 8 weeks. The classes will be taught by a GRA. Classes 1 \& 2 will focus on common cognitive problems in T2DM and strategies to improve cognitive skills. Classes 3 \& 4 focus on lifestyle changes to support cognitive functioning and DM-SM skills. Each online class will follow the same format: (1) introduction/revisiting content from the previous class; (2) review of progress on computer exercises; (3) practicing cognitive strategies in class; and (4) a weekly topic. The GRA will also prescribe exercises for the following weeks.
BEHAVIORALBrain GamesThe computer-training component uses a model for cognitive training that adapts to the user through an integrated hierarchical structure. The BrainHQ website houses the interactive program that runs on standard web browsers. Participants will only need a computer, smart phone, or tablet with Internet access to securely log onto the website. Each participant will be registered by the project staff using anonymous ID numbers that will allow unlimited access during the study. The website stores each session completed, and participants can start subsequent sessions wherever they stopped the last time logged on.

Timeline

Start date
2021-11-01
Primary completion
2023-09-28
Completion
2024-02-28
First posted
2021-04-05
Last updated
2024-12-02
Results posted
2024-12-02

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04831775. Inclusion in this directory is not an endorsement.