Diabetes Mellitus, Type 2NCT04831775

Cognitive Training for Diabetes Self-Management

A study testing Memory, Attention, and Problem Solving Skills for Diabetes and Brain Games in people with Diabetes Mellitus, Type 2, run by University of Texas at Austin at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Diabetes Mellitus, Type 2
What is being tested?: Memory, Attention, and Problem Solving Skills for Diabetes and Brain Games
Type of treatment: Pill or oral medicine, Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 1 siteUnited States
Study dates: 1 Nov 2021to 28 Feb 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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%.

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

The University of Texas at Austin
Austin, Texas, 78712

Other trials in United States

About this study

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.

Read the 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: Diabetes Mellitus, Type 2
Being tested: Memory, Attention, and Problem Solving Skills for Diabetes, Brain Games
Keywords: cognitive function, glucose variability
Medical subject headings: Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Memory, Attention, and Problem Solving Skills for DiabetesBehavioural
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 GamesBehavioural
Also called BrainHQ
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.

Study groups in NCT04831775
Study group	Role	What they receive
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. Receives: 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. Receives: Behavioral: Brain Games

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Baseline and week 22
Change in Glucose Variability at Week 22
Difference in the standard deviation of glucose readings from baseline and week 22
Measured: 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.
Measured: Baseline and week 22

Secondary outcomes (1)

Change in Perceived Cognitive Function at Week 22
Patient-Reported Outcomes Measurement Information System (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. Items include questions such as, "In the past 7 days, my thinking has been slow" and "In the past 7 days I have had trouble concentrating." Items are ranked on a 1 to 5 scale (5 = very often/several times a day to 1 = never). Scores range from 32 to 160. Higher scores indicate more perceived difficulty with cognitive function.
Measured: Baseline and week 22

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 202128 Feb 2024

First posted5 Apr 2021
Study start1 Nov 2021
Primary completion28 Sep 2023
Study completion28 Feb 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04831775
Sponsor's protocol ID: 00000464
Other IDs: R21NR019266
Status last verified: Nov 2024
First submitted: 2 Apr 2021
Last updated: 2 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: 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.

Publications

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.
PubMed 38838256
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.
PubMed 37186584

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cognitive Training for Diabetes Self-Management
ClinicalTrials.gov ID: NCT04831775
Acronym / sponsor ID: 00000464
Conditions: Diabetes Mellitus, Type 2
Keywords: cognitive function, glucose variability
Study type: Interventional
Recruitment status: Completed
Enrolment: 95 participants (actual)
Lead sponsor: University of Texas at AustinUniversity, hospital or other
Collaborators: National Institute of Nursing Research (NINR)
Study start: 1 Nov 2021 (actual)
Primary completion: 28 Sep 2023 (actual)
Study completion: 28 Feb 2024 (actual)
First posted: 5 Apr 2021 (actual)
Results: Posted 2 Dec 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Memory, Attention, and Problem Solving Skills for Diabetes	Experimental	Behavioral: Memory, Attention, and Problem Solving Skills for DiabetesThe 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.
Brain Games Only	Active comparator	Behavioral: Brain GamesAn 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.

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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%.

Key exclusion criteria (3 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Memory, 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.	Behavioural	Memory, Attention, and Problem Solving Skills for Diabetes
Brain GamesAlso: BrainHQThe 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.	Behavioural	Brain Games Only

Primary outcome

Change in A1C at Week 22
Time frame: Baseline and 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.
Change in Diabetes Self-management Adherence at Week 22
Time frame: Baseline and 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.
Change in Glucose Variability at Week 22
Time frame: Baseline and week 22
Difference in the standard deviation of glucose readings from 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
Time frame: Baseline and 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.

1 secondary outcome

Change in Perceived Cognitive Function at Week 22
Time frame: Baseline and week 22

Results and safety

Results posted to the registry on 2 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Memory, Attention, and Problem Solving Skills for Diabetes	47	36
Brain Games Only	48	35

Primary outcome: Change in A1C at Week 22

Time frame: Baseline and week 22. Mean (Standard Deviation). Unit: percentage of glycated hemoglobin

Measure	Memory, Attention, and Problem Solving Skills for Diabetes n = 36	Brain Games Only n = 35
Value	-1.5 (0.8)	1.0 (0.3)

Primary outcome: Change in Diabetes Self-management Adherence at Week 22

Time frame: Baseline and week 22. Mean (Standard Deviation). Unit: score on a scale

Measure	Memory, Attention, and Problem Solving Skills for Diabetes n = 36	Brain Games Only n = 35
Baseline	2.3 (1.2)	2.2 (1.4)
Week 22	2.2 (1.1)	3.4 (2.7)

Primary outcome: Change in Glucose Variability at Week 22

Time frame: Baseline and week 22. Mean (Standard Deviation). Unit: mg/dl

Measure	Memory, Attention, and Problem Solving Skills for Diabetes n = 36	Brain Games Only n = 35
Value	47.6 (27.1)	53.2 (30.1)

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

Time frame: Baseline and week 22. Mean (Standard Deviation). Unit: correct number of responses

Measure	Memory, Attention, and Problem Solving Skills for Diabetes n = 36	Brain Games Only n = 35
Value	10.4 (3.2)	4.2 (1.3)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Each participant was assessed for adverse events for 3 months (duration of time spent in the study).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Memory, Attention, and Problem Solving Skills for Diabetes	0 of 47 (0%)	0 of 47 (0%)	0 of 47
Brain Games Only	0 of 48 (0%)	0 of 48 (0%)	0 of 48

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38838256Kim 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.
Derived from this study: PubMed 37186584Cuevas 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.
Individual participant dataSharing planned: No. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Heather E Cuevas, PhD principal investigator

The University of Texas at Austin

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Memory, Attention, and Problem Solving Skills for Diabetes and Brain Games in people with Diabetes Mellitus, Type 2, run by University of Texas at Austin at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 2 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in A1C at Week 22 (time frame: Baseline and week 22). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04831775, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2024.