Cognitive Training for Diabetes Self-Management

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Cognitive Training for Diabetes Self-Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04831775
• Other study ID #: 00000464
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: February 28, 2024

Study information

• Verified date: May 2024
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 71
• Est. completion date: February 28, 2024
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Behavioral:
• Memory, Attention, and Problem Solving Skills for Diabetes
The 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.
• Brain Games
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. 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.

Locations

Country	Name	City	State
United States	The University of Texas at Austin	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in A1C at week 22	Measure of average glucose over 3 months	Baseline, and week 22
Primary	Change in diabetes self-management adherence at week 22	Summary of Diabetes Self-Care Activities: 8 items; Brief assessment of diabetes related psychosocial self-efficacy. Responses are made on a 5-point scale (1 = strongly disagree to 4 = strongly agree) to items such as "I believe that I am able to turn my diabetes goals into a workable plan." Cronbach's alphas range from 0.81 to 0.96. Higher scores indicate higher levels of self-management adherence.	Baseline, week 8, and week 22
Primary	Change in glucose variability at week 22	Continuous Glucose Monitor (CGM): To be worn for 2 weeks at baseline and week 22; The following glucose composites will be calculated: (1) the overall mean, (2) the proportion of readings indicating hypoglycemia (%<70mg/dL), (3) the proportion of readings indicating hyperglycemia (% >160mg/dL), (4) the proportion of out of range readings (% either <70mg/dL or >160mg/dL) and (5) the SD of CGM glucose readings.	Baseline, week 8, and week 22
Primary	Change in attention, visual scanning and motor speed at week 22	Symbol Digit Modalities Test: Participants are given a series of symbols and digits and instructed to verbalize the digit associated with each symbol. The number of correct responses in 90 sec constitutes the score, and higher scores reflect better cognitive function.	Baseline, week 8, and week 22
Secondary	Change in perceived cognitive function at week 22	PROMIS v2.0 - Cognitive Function: 32 items; assess patient-perceived cognitive deficits including the areas of mental acuity, concentration, verbal and nonverbal memory, and verbal fluency. Reliability has been measured at 0.94 and test-retest correlation at 0.83. Higher scores indicate more perceived difficulty with cognitive function.	Baseline, week 8, and week 22