Cognitive Training for Diabetes Self-Management

The University of Texas System (UT)

Status: Completed

Conditions: Diabetes Mellitus, Type 2

Treatments: Behavioral: Memory, Attention, and Problem Solving Skills for Diabetes; Behavioral: Brain Games

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04831775

00000464

R21NR019266 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 50+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• age 50 years old or greater
• T2DM diagnosis for 2 years
• access to phone and Internet
• Score of ≥10 on the Perceived Deficits Questionnaire (PDQ)
• A1C of >7%.

Exclusion criteria

• a diagnosis of dementia/head injury
• score of >5 on the Mini-Cog
• inability to speak English, and T1DM diagnosis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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95 participants in 2 patient groups

Memory, Attention, and Problem Solving Skills for Diabetes

Experimental group

Description:

The intervention is composed of 4 small-group webinar classes and home-based individual online cognitive skills practice over 8 weeks. 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. The 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. 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. The intervention group will be asked to practice 20 minutes, 7 days a week.

Treatment:

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

Brain Games Only

Active Comparator group

Description:

An active control group will be used. The differing variable between the two groups is the class sessions. Those randomized to the control group will only receive a link to the BrainHQ games site. A specific amount of practice will not be prescribed, but the frequency and duration of participant's practice will be obtained from BrainHQ. Participants will receive a weekly phone call to maintain connection to the study. Data collection will be on the same schedule as the intervention group.

Treatment:

Behavioral: Brain Games