Back to resultsCognitive Training for Diabetes Self-Management
Primary Purpose
Diabetes Mellitus, Type 2
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memory, Attention, and Problem Solving Skills for Diabetes
Brain Games
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring cognitive function, glucose variability
Eligibility Criteria
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
Sites / Locations
- The University of Texas at AustinRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Memory, Attention, and Problem Solving Skills for Diabetes
Brain Games Only
Arm 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.
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.
Outcomes
Primary Outcome Measures
Change in A1C at week 22
Measure of average glucose over 3 months
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.
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.
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04831775
First Posted
April 2, 2021
Last Updated
May 16, 2022
Sponsor
University of Texas at Austin
1. Study Identification
Unique Protocol Identification Number
NCT04831775
Brief Title
Cognitive Training for Diabetes Self-Management
Official Title
Cognitive Training for Diabetes Self-Management
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2021 (Actual)
Primary Completion Date
March 28, 2023 (Anticipated)
Study Completion Date
March 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Texas at Austin
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
cognitive function, glucose variability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Masking Description
The intervention will be delivered by a research assistant and outcome data collection will be done by two other research assistants
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Memory, Attention, and Problem Solving Skills for Diabetes
Arm Type
Experimental
Arm 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.
Arm Title
Brain Games Only
Arm Type
Active Comparator
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Memory, Attention, and Problem Solving Skills for Diabetes
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Brain Games
Other Intervention Name(s)
BrainHQ
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in A1C at week 22
Description
Measure of average glucose over 3 months
Time Frame
Baseline, and week 22
Title
Change in diabetes self-management adherence at week 22
Description
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.
Time Frame
Baseline, week 8, and week 22
Title
Change in glucose variability at week 22
Description
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.
Time Frame
Baseline, week 8, and week 22
Title
Change in attention, visual scanning and motor speed at week 22
Description
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.
Time Frame
Baseline, week 8, and week 22
Secondary Outcome Measure Information:
Title
Change in perceived cognitive function at week 22
Description
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.
Time Frame
Baseline, week 8, and week 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Heather E Cuevas, PhD
Phone
15124226059
Email
hcuevas@mail.nur.utexas.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heather E Cuevas, PhD
Organizational Affiliation
The University of Texas at Austin
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Texas at Austin
City
Austin
State/Province
Texas
ZIP/Postal Code
78712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Heather E Cuevas, PhD
Phone
512-422-6059
Email
hcuevas@mail.nur.utexas.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Only de-identified quantitative and qualitative data will be available to other qualified researchers upon request from the PI two years after completion of the study. After review of the purpose of the data request to make sure it is consistent with the original project goals and verification that the request meets IRB approval, de-identified data may be shared with researchers two years after completion of the study. It is recognized that the government reserves the right to identify repositories for submission of data for archive as stated in the grant instructions.
Learn more about this trial
Cognitive Training for Diabetes Self-Management
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