Trial Outcomes & Findings for Cognitive Training for Diabetes Self-Management (NCT NCT04831775)
NCT ID: NCT04831775
Last Updated: 2024-12-02
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
95 participants
Primary outcome timeframe
Baseline and week 22
Results posted on
2024-12-02
Participant Flow
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.
Participant milestones
| Measure |
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 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. The website stored each session and participants can start subsequent sessions wherever they stopped the last time logged on. The intervention group was asked to practice 20 minutes, 7 days a week.
|
Brain Games Only
An active control group was used. The differing variable between the two groups was 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 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 be on the same schedule as the intervention group.
|
|---|---|---|
|
Overall Study
STARTED
|
47
|
48
|
|
Overall Study
Received Intervention (Week 0)
|
40
|
48
|
|
Overall Study
Time 2 Follow-up (Week 2)
|
38
|
40
|
|
Overall Study
COMPLETED
|
36
|
35
|
|
Overall Study
NOT COMPLETED
|
11
|
13
|
Reasons for withdrawal
| Measure |
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 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. The website stored each session and participants can start subsequent sessions wherever they stopped the last time logged on. The intervention group was asked to practice 20 minutes, 7 days a week.
|
Brain Games Only
An active control group was used. The differing variable between the two groups was 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 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 be on the same schedule as the intervention group.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
13
|
Baseline Characteristics
Cognitive Training for Diabetes Self-Management
Baseline characteristics by cohort
| Measure |
Memory, Attention, and Problem Solving Skills for Diabetes
n=47 Participants
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.
|
Brain Games Only
n=48 Participants
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.
|
Total
n=95 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
65.9 years
STANDARD_DEVIATION 5.8 • n=7 Participants
|
65.6 years
STANDARD_DEVIATION 5.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
15 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
32 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
47 participants
n=5 Participants
|
48 participants
n=7 Participants
|
95 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 22Measure 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.
Outcome measures
| Measure |
Memory, Attention, and Problem Solving Skills for Diabetes
n=36 Participants
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 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 was registered by the project staff using anonymous ID numbers that allowed 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.
|
Brain Games Only
n=35 Participants
An active control group was used. The differing variable between the two groups was 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 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 will be on the same schedule as the intervention group.
|
|---|---|---|
|
Change in A1C at Week 22
|
-1.5 percentage of glycated hemoglobin
Standard Deviation 0.8
|
1.0 percentage of glycated hemoglobin
Standard Deviation 0.3
|
PRIMARY outcome
Timeframe: Baseline and week 22Summary 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.
Outcome measures
| Measure |
Memory, Attention, and Problem Solving Skills for Diabetes
n=36 Participants
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 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 was registered by the project staff using anonymous ID numbers that allowed 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.
|
Brain Games Only
n=35 Participants
An active control group was used. The differing variable between the two groups was 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 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 will be on the same schedule as the intervention group.
|
|---|---|---|
|
Change in Diabetes Self-management Adherence at Week 22
Baseline
|
2.3 score on a scale
Standard Deviation 1.2
|
2.2 score on a scale
Standard Deviation 1.4
|
|
Change in Diabetes Self-management Adherence at Week 22
Week 22
|
2.2 score on a scale
Standard Deviation 1.1
|
3.4 score on a scale
Standard Deviation 2.7
|
PRIMARY outcome
Timeframe: Baseline and week 22Difference in the standard deviation of glucose readings from baseline and week 22
Outcome measures
| Measure |
Memory, Attention, and Problem Solving Skills for Diabetes
n=36 Participants
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 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 was registered by the project staff using anonymous ID numbers that allowed 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.
|
Brain Games Only
n=35 Participants
An active control group was used. The differing variable between the two groups was 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 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 will be on the same schedule as the intervention group.
|
|---|---|---|
|
Change in Glucose Variability at Week 22
|
47.6 mg/dl
Standard Deviation 27.1
|
53.2 mg/dl
Standard Deviation 30.1
|
PRIMARY outcome
Timeframe: Baseline and week 22Symbol 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.
Outcome measures
| Measure |
Memory, Attention, and Problem Solving Skills for Diabetes
n=36 Participants
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 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 was registered by the project staff using anonymous ID numbers that allowed 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.
|
Brain Games Only
n=35 Participants
An active control group was used. The differing variable between the two groups was 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 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 will be on the same schedule as the intervention group.
|
|---|---|---|
|
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
|
4.2 correct number of responses
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: Baseline and week 22Patient-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.
Outcome measures
| Measure |
Memory, Attention, and Problem Solving Skills for Diabetes
n=36 Participants
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 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 was registered by the project staff using anonymous ID numbers that allowed 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.
|
Brain Games Only
n=35 Participants
An active control group was used. The differing variable between the two groups was 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 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 will be on the same schedule as the intervention group.
|
|---|---|---|
|
Change in Perceived Cognitive Function at Week 22
|
15.4 total score on a scale
Standard Deviation 3.7
|
8.5 total score on a scale
Standard Deviation 3.1
|
Adverse Events
Memory, Attention, and Problem Solving Skills for Diabetes
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brain Games Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place