Cognitive Training for Diabetes Self-Management

NCT04831775 | Completed Results DMC

• 2 other identifiers: 00000464R21NR019266
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

cognitive function; glucose variability

Outcome Measures

Primary Outcomes (4)

• Change in A1C at Week 22

  Measure of difference in average glucose over 22 weeks; A1C is one time point that measures a 3 month average glucose (e.g. and A1C of 7% = approximately a 154mg/dl average glucose for the past 3 months) therefore it can be measured at baseline and week 22 and still reflect a 3 month average at both those time points.

  Baseline and week 22

• 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 5 = strongly agree) to items such as "I believe that I am able to turn my diabetes goals into a workable plan." Higher scores indicate higher levels of self-management adherence.

  Baseline and week 22

• Change in Glucose Variability at Week 22

  Difference in the standard deviation of glucose readings from baseline and week 22

  Baseline and week 22

• Change From Baseline to Week 22 in the Number of Correct Responses in 90 Seconds on the Symbol Digit Modalities Test

  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 and week 22

Secondary Outcomes (1)

• Change in Perceived Cognitive Function at Week 22

  Baseline and week 22

Study Arms (2)

Memory, Attention, and Problem Solving Skills for Diabetes

EXPERIMENTAL

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.

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

Brain Games Only

ACTIVE COMPARATOR

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.

Behavioral: Brain Games

Interventions

Memory, Attention, and Problem Solving Skills for Diabetes BEHAVIORAL

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.

Memory, Attention, and Problem Solving Skills for Diabetes

Brain Games BEHAVIORAL

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.

Also known as: BrainHQ

Brain Games Only

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

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

Sponsors & Collaborators

• University of Texas at Austin: lead
• National Institute of Nursing Research (NINR): collaborator

Study Sites (1)

The University of Texas at Austin

Austin, Texas, 78712, United States

Location

Related Publications (2)

• Kim J, Cuevas H. Musical Activity Engagement, Depressive Symptoms, Physical Activity, and Cognitive Function in People With Type 2 Diabetes. Nurs Res. 2024 Sep-Oct 01;73(5):381-389. doi: 10.1097/NNR.0000000000000749. Epub 2024 May 20.

  PMID: 38838256 DERIVED

• Cuevas H, Stuifbergen AK, Hilsabeck RC, Sales A, Wood S, Kim J. The role of cognitive rehabilitation in people with type 2 diabetes: A study protocol for a randomized controlled trial. PLoS One. 2023 May 15;18(5):e0285553. doi: 10.1371/journal.pone.0285553. eCollection 2023.

  PMID: 37186584 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Dr. Heather Cuevas
• Organization: The University of Texas at Austin

hcuevas@mail.nur.utexas.edu

5124226059

Study Officials

• Heather E Cuevas, PhD

  The University of Texas at Austin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The intervention will be delivered by a research assistant and outcome data collection will be done by two other research assistants
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2021
• First Posted: April 5, 2021
• Study Start: November 1, 2021
• Primary Completion: September 28, 2023
• Study Completion: February 28, 2024
• Last Updated: December 2, 2024
• Results First Posted: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)