Diabetes Mellitus, Type 2
Conditions
Keywords
cognitive function, glucose variability
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.
Interventions
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.
BEHAVIORALBrain 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.
Sponsors
National Institute of Nursing Research (NINR)
University of Texas at Austin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
The intervention will be delivered by a research assistant and outcome data collection will be done by two other research assistants
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in A1C at Week 22 | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Perceived Cognitive Function at Week 22 | Baseline and 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. |
Countries
United States
Participant flow
Pre-assignment details
The study required 10 participants in the pool available to start the study for randomization to occur. Race/ethnicity and gender were tracked to ensure adequate sample representation. Once another 10 participants were recruited they were randomly assigned to the control or intervention group. Assignment to each group happened in groups of 10 until the full sample was obtained. This was so that each group of ten would be in the same intervention group and attend the online classes together.
Participants by arm
| Arm | Count |
|---|---|
| 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 over 8 weeks. Classes 1 & 2 focused on common cognitive problems in T2DM and strategies to improve cognitive skills. Classes 3 & 4 focused on lifestyle changes to support cognitive functioning and DM-SM skills. The computer-training component used 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 was 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 could start subsequent sessions wherever they stopped the last time logged on. The intervention group was asked to practice 20 minutes, 7 days a week. | 47 |
| Brain Games Only An active control group was used. The differing variable between the two groups is the class sessions. Those randomized to the control group only received a link to the BrainHQ games site. A specific amount of practice was not be prescribed, but the frequency and duration of participant's practice was obtained from BrainHQ. Participants received a weekly phone call to maintain connection to the study. Data collection was on the same schedule as the intervention group. | 48 |
| Total | 95 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 11 | 13 |
Baseline characteristics
| Characteristic | Memory, Attention, and Problem Solving Skills for Diabetes | Brain Games Only | Total |
|---|---|---|---|
| Age, Continuous | 65.2 years STANDARD_DEVIATION 6.2 | 65.9 years STANDARD_DEVIATION 5.8 | 65.6 years STANDARD_DEVIATION 5.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants | 18 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 32 Participants | 30 Participants | 62 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 47 participants | 48 participants | 95 participants |
| Sex: Female, Male Female | 28 Participants | 28 Participants | 56 Participants |
| Sex: Female, Male Male | 19 Participants | 20 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 47 | 0 / 48 |
| other Total, other adverse events | 0 / 47 | 0 / 48 |
| serious Total, serious adverse events | 0 / 47 | 0 / 48 |
Outcome results
Primary
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.
Time frame: Baseline and week 22
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, and Problem Solving Skills for Diabetes | Change From Baseline to Week 22 in the Number of Correct Responses in 90 Seconds on the Symbol Digit Modalities Test | 10.4 correct number of responses | Standard Deviation 3.2 |
| Brain Games Only | Change From Baseline to Week 22 in the Number of Correct Responses in 90 Seconds on the Symbol Digit Modalities Test | 4.2 correct number of responses | Standard Deviation 1.3 |
Primary
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.
Time frame: Baseline and week 22
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, and Problem Solving Skills for Diabetes | Change in A1C at Week 22 | -1.5 percentage of glycated hemoglobin | Standard Deviation 0.8 |
| Brain Games Only | Change in A1C at Week 22 | 1.0 percentage of glycated hemoglobin | Standard Deviation 0.3 |
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 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.
Time frame: Baseline and week 22
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Memory, Attention, and Problem Solving Skills for Diabetes | Change in Diabetes Self-management Adherence at Week 22 | Baseline | 2.3 score on a scale | Standard Deviation 1.2 |
| Memory, Attention, and Problem Solving Skills for Diabetes | Change in Diabetes Self-management Adherence at Week 22 | Week 22 | 2.2 score on a scale | Standard Deviation 1.1 |
| Brain Games Only | Change in Diabetes Self-management Adherence at Week 22 | Baseline | 2.2 score on a scale | Standard Deviation 1.4 |
| Brain Games Only | Change in Diabetes Self-management Adherence at Week 22 | Week 22 | 3.4 score on a scale | Standard Deviation 2.7 |
Primary
Change in Glucose Variability at Week 22
Difference in the standard deviation of glucose readings from baseline and week 22
Time frame: Baseline and week 22
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, and Problem Solving Skills for Diabetes | Change in Glucose Variability at Week 22 | 47.6 mg/dl | Standard Deviation 27.1 |
| Brain Games Only | Change in Glucose Variability at Week 22 | 53.2 mg/dl | Standard Deviation 30.1 |
Secondary
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.
Time frame: Baseline and week 22
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory, Attention, and Problem Solving Skills for Diabetes | Change in Perceived Cognitive Function at Week 22 | 15.4 total score on a scale | Standard Deviation 3.7 |
| Brain Games Only | Change in Perceived Cognitive Function at Week 22 | 8.5 total score on a scale | Standard Deviation 3.1 |