Diabetes Mellitus, Type 2
Conditions
Keywords
computerize cognitive training, dementia, cognitive decline, Diabetes Mellitus, Type 2
Brief summary
Computerized cognitive training (CCT) is an intervention has improved cognitive functioning in the elderly with and without cognitive impairment. The investigators will study the effect of a CCT program over an active control, classic computerized games. The outcomes will be memory and executive functions/attention, diabetes elf-management and adherence to medications, and glycemic and blood pressure control. Non-demented elderly Veterans with diabetes mellitus, who are at high risk for cognitive impairment, will be from the James J. Peters, Bronx, NY and Ann Arbor, MI VAMCs. This novel potential service fits the portfolio of the Quality Enhancement Research Initiative for Diabetes Mellitus (QUERI-DM) for which the Ann Arbor VAMC is a primary center. If successful, the VA National Center for Prevention and MyHeatheVet will collaborate in disseminating results to encourage implementation throughout the VA
Detailed description
Project Background: Diabetes mellitus (DM) has consistently been associated with increased risk for cognitive decline, mild cognitive impairment, and dementia in the elderly. Even minor cognitive impairments in nondemented individuals dramatically affect disease self-management. This, in turn, is associated with poor glycemic and blood pressure control in diabetes, which by themselves increase the risk of dementia, provoking a reinforcing cycle of disease. Thus, it is imperative to find interventions to delay or prevent cognitive compromise in diabetic patients, that can be relatively easily and rapidly implemented, and that are not cost prohibitive. This is especially true in the VA, in view of the high incidence of both diabetes and dementia in the growing population of elderly Veterans. Epidemiologic evidence suggests modifiable life-style factors, including cognitive activity, may prevent or delay the onset of cognitive decline. Computerized cognitive training (CCT) is an intervention that has shown promising results in the improvement of cognitive functioning, more consistently in non-demented elderly, with additional benefits from booster training sessions. To date, studies of CCT have typically only examined cognitive outcomes, and only shortly after the intervention. The proposed CCT program, Personal Coach from Cognifit, is designed to improve cognition of elderly persons by targeting their weak cognitive functions, using a personally tailored training plan. The proposed study will provide the first evaluation of the effects of CCT on DM self-management behavior and clinical outcomes, in addition to cognition. Project Objectives: Aim 1A: To determine whether the CCT, relative to the active control games program, improves cognition (memory and executive functions/attention), DM-related behavior (DM self-management and medication adherence), and clinical outcomes (glycemic and blood pressure control), 6 and 12 months after the intervention. Aim 1B: To demonstrate efficacy by improvement in behavioral outcomes (DM self-management and medication adherence) 6 months after the intervention. Aim 2: To document the effects of CCT on the successive changes in memory and executive functions/attention, DM self-management and medication adherence, and glycemic and blood pressure control. Aim 3: To explore the impact of demographic (age, education, ethnicity, site) and health (ADL/IADL, health literacy, depression, dementia family history, lifestyle factors) characteristics, on the intervention effects. Project Methods: Non-demented DM elderly from the James J. Peters (Bronx, NY) and Ann Arbor (MI) VAMCs will be randomized to CCT or games intervention and perform the respective program 3 days per week (every other day), for 20 minutes, for 24 total sessions. Four months after the intervention, subjects will receive a 1-week booster training. Subjects will be assessed at baseline; and immediately, 6 months, and 12 months after the intervention. At each time point, assessments will be cognitive function, DM self-management, and blood pressure; blood will be drawn for HbA1c measurement. VA records will be used to monitor medication adherence. Longitudinal mixed model analyses will assess the effects of the intervention on change in outcomes over time. Path analyses will evaluate the inter-relationships among changes in cognition, DM self-management, and clinical outcomes for each intervention at 6 and 12 months.
Interventions
OTHERcomputerized cognitive training
A variety of computer games tailored to address their personal cognitive deficits.
OTHERcontrol games
A variety of computer games that are engaging but not designed to enhance cognitive skills
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 55 years old or above * A diagnosis of type 2 diabetes * Access to computer and internet * Has an informant * Self-management score 18 or below
Exclusion criteria
* Dementia or prescribed AD medications * Major medical, psychiatric, or neurological conditions that affect cognitive performance * Severe impairment of vision, hearing or fine motor control necessary for computer operation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes Self-management | 6 months after the intervention | The data below represent values of the Diabetes Self-Management Questionnaire (DSMQ) scores at 6 months post-intervention, the primary outcome. DSMQ scores range from 0 to 20, with higher scores indicating better self-management, the same as baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Memory | 6 month after the intervention | As with baseline memory score, the outcome score was the mean of Word List Memory and Logical Memory (Story A) tests, each providing three scores: immediate recall, delayed recall, and recognition tasks after conversion to a common unit of measurement. However, to standardize these outcome tasks, the statistics from which the baseline z-scores were calculated (mean\_baseline and SD\_baseline from the full sample before randomization) were used, rather than the means of the given outcome period: standardized score = (outcome task score - mean\_baseline) / SD\_baseline. Thus, while baseline task scores were conventional z-scores, the six-month post-intervention standardized scores were not, in order to best inform the outcome measure and better facilitate comparison with baseline. The data below represent outcome values at 6 months. Like the baseline measure, this measure does not have a theoretical minimum or maximum, and higher scores indicate better performance. |
| Executive Function/Attention | 6 months after the intervention | As with baseline attention/executive function score, the outcome score was the mean of the Target Cancellation (TMX, Diamond), Trail Making (A, B; reversed), Digit Symbol Substitution, and, Digit Span (Forward, Backward) tasks after conversion to a common unit of measurement. However, to standardize these outcome tasks, the statistics from which the baseline z-scores were calculated (mean\_baseline and SD\_baseline from the full sample before randomization) were used, rather than the means of the given outcome period: standardized score = (outcome task score - mean\_baseline) / SD\_baseline. Thus, while baseline task scores were conventional z-scores, the six-month post-intervention standardized scores were not, in order to best inform the outcome measure and better facilitate comparison with baseline. The data below represent outcome values at 6 months. Like the baseline measure, this measure does not have a theoretical minimum or maximum, and higher scores indicate better performance. |
| Hemoglobin A1c | 6 months after the intervention | A measure of glycemic control derived from blood sample. The data below represent outcome values at 6 months. Higher values represent poorer control of glycation. |
| Medication Adherence | 12 months post-intervention | Medication adherence was assessed by the Continuous Multiple interval measure of Gaps in therapy (CMG), using diabetes medication refill data from the CPRS for the full year post-intervention. To calculate CMG percentage, the total number of days without medication refills when due - refill gap-days - was divided by 365, the days in a year. Multiplying this fraction by 100 provides the CMG percentage, where a higher percentage indicates worse medication adherence. The data below represent the CMG percentage at 12 months post-intervention. |
| Diastolic Blood Pressure | assessed 6 months after intervention | A measure of the extent of pressure of the blood in the arteries when the heart is filling, assessed using a blood pressure cuff. Higher values indicate worse outcome. The data below represent outcome values at 6 months. |
| Prospective Memory | 6 months after the intervention | The Appointments - Delayed Recall subtest of the Rivermead Behavioral Memory Test - Third Edition (RBMT - 3) is a test of prospective memory - remembering to do something in the future. The examinee was instructed to ask two questions when an alarm rings 25 minutes later. For each question, a score of 2 was given when a participant responded without requiring a prompt, 1 point when a prompt was needed and elicited a correct response, and 0 when there was no appropriate response despite prompting. Scores were summed and the total score ranges from 0 to 4. Higher scores indicate better performance. The data below represent outcome values at 6 months. |
| Systolic Blood Pressure | 6 months after the intervention | A measure of the extent of pressure that blood is exerting against an individual's artery walls when the heart beats, assessed using a blood pressure cuff. Higher values indicate worse outcome. The data below represent outcome values at 6 months. |
Countries
United States
Participant flow
Recruitment details
Recruitment Period: 4/7/2015 to 1/11/2018 Primary Recruitment Outreach: Mailings to potential participants Recruitment locations: James J. Peters Veterans Affairs Medical Center, Bronx, New York & Ann Arbor Veterans Affairs Medical Center, Ann Arbor, Michigan
Pre-assignment details
Review of demographic and medical records in the VA's Computerized Patient Record System, baseline assessment of diabetes self-management and cognitive functions, assessment of computer/internet availability, identification of a potential informant. 199 Veterans enrolled, but 19 were subsequently excluded prior to randomization
Participants by arm
| Arm | Count |
|---|---|
| Computerized Cognitive Training (CCT) Randomly selected subjects perform adaptive computerized cognitive training (CCT) program, CognifitTM\], involving a variety of computer games tailored to address their personal cognitive deficits. Cognifit is a web-accessed CCT program designed to improve cognition by targeting the user's weaker cognitive functions. The challenge at each session was adapted according to the user's prior performance and a cognitive score pertaining to the specific session was provided. Participants were instructed to have sessions three times per week for eight weeks, with at least one day of rest between sessions, for a total of 24 sessions. Each 20 minute session included a unique combination of three games accessing a variety of cognitive abilities. | 90 |
| Active Control As for the CCT intervention group, these randomly selected subjects performed three games each session from the same set of Cognifit computer games over the same eight week schedule. The activity differed only in the program did not target training games nor adaptive in their level of challenge based on prior performance and no cognitive score was provided at the end of the session. | 90 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Mo. Post-Intervention Assessment | Death | 1 | 0 |
| 12 Mo. Post-Intervention Assessment | End of study | 10 | 10 |
| 12 Mo. Post-Intervention Assessment | Moved away | 1 | 0 |
| 12 Mo. Post-Intervention Assessment | Withdrawal by Subject | 0 | 2 |
| 6 Mo. Post-Intervention Assessment | Death | 0 | 1 |
| 6 Mo. Post-Intervention Assessment | Illness | 1 | 2 |
| 6 Mo. Post-Intervention Assessment | Moved away | 0 | 2 |
| 6 Mo. Post-Intervention Assessment | Temporarily away | 1 | 4 |
| 6 Mo. Post-Intervention Assessment | Withdrawal by Subject | 3 | 3 |
| Post-intervention Assessment | Death | 2 | 2 |
| Post-intervention Assessment | Illness | 3 | 2 |
| Post-intervention Assessment | lost computer access | 1 | 1 |
| Post-intervention Assessment | Lost to Follow-up | 8 | 5 |
| Post-intervention Assessment | Moved away | 3 | 1 |
| Post-intervention Assessment | Temporarily away | 3 | 1 |
| Post-intervention Assessment | Withdrawal by Subject | 11 | 9 |
Baseline characteristics
| Characteristic | Active Control | Total | Computerized Cognitive Training (CCT) |
|---|---|---|---|
| Age, Continuous | 70.7 years STANDARD_DEVIATION 6.6 | 70.1 years STANDARD_DEVIATION 6.6 | 69.6 years STANDARD_DEVIATION 6.5 |
| Attention/Executive Functions | 0.017 average of z-scores STANDARD_DEVIATION 0.628 | 0.000 average of z-scores STANDARD_DEVIATION 0.619 | -0.017 average of z-scores STANDARD_DEVIATION 0.613 |
| Clinical Dementia Rating (CDR) Scale CDR = 0 | 74 Participants | 151 Participants | 77 Participants |
| Clinical Dementia Rating (CDR) Scale CDR = 0.5 | 16 Participants | 29 Participants | 13 Participants |
| Cognitive Self-Report Questionnaire (CSRQ) | 62.3 units on a scale STANDARD_DEVIATION 14.1 | 62.9 units on a scale STANDARD_DEVIATION 13.4 | 63.4 units on a scale STANDARD_DEVIATION 12.8 |
| Diabetes Self-Management Questionnaire (DSMQ) | 14.3 units on a scale STANDARD_DEVIATION 2.4 | 14.3 units on a scale STANDARD_DEVIATION 2.3 | 14.2 units on a scale STANDARD_DEVIATION 2.3 |
| Diastolic Blood Pressure | 73.6 mmHg STANDARD_DEVIATION 10.8 | 74.1 mmHg STANDARD_DEVIATION 10.5 | 74.7 mmHg STANDARD_DEVIATION 10.3 |
| Geriatric Depression Scale | 6.3 units on a scale STANDARD_DEVIATION 6.4 | 6.6 units on a scale STANDARD_DEVIATION 6.3 | 7.0 units on a scale STANDARD_DEVIATION 6.2 |
| Hemoglobin A1c (HbA1c) | 7.5 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.2 | 7.6 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.4 | 7.7 percentage of glycosylated hemoglobin STANDARD_DEVIATION 1.5 |
| Medication Adherence | 0.146 percentage of refill gap-days per year STANDARD_DEVIATION 0.142 | 0.148 percentage of refill gap-days per year STANDARD_DEVIATION 0.125 | 0.150 percentage of refill gap-days per year STANDARD_DEVIATION 0.107 |
| Memory Score | 0.009 average of z-scores STANDARD_DEVIATION 0.8 | 0.000 average of z-scores STANDARD_DEVIATION 0.76 | -0.009 average of z-scores STANDARD_DEVIATION 0.723 |
| Mini-Mental Status Exam (MMSE) | 28.3 units on a scale STANDARD_DEVIATION 1.4 | 28.4 units on a scale STANDARD_DEVIATION 1.4 | 28.5 units on a scale STANDARD_DEVIATION 1.3 |
| Race/Ethnicity, Customized Black, non-Hispanic | 27 Participants | 52 Participants | 25 Participants |
| Race/Ethnicity, Customized Hispanic | 19 Participants | 34 Participants | 15 Participants |
| Race/Ethnicity, Customized other/unknown | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized White, non-Hispanic | 43 Participants | 91 Participants | 48 Participants |
| Region of Enrollment United States | 90 Participants | 180 Participants | 90 Participants |
| Rivermead Behavioral Memory Prospective Memory (Appointments Subtest) | 2.7 units on a scale STANDARD_DEVIATION 1.3 | 2.8 units on a scale STANDARD_DEVIATION 1.3 | 2.8 units on a scale STANDARD_DEVIATION 1.3 |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 1 Participants |
| Sex: Female, Male Male | 87 Participants | 176 Participants | 89 Participants |
| Short -Test of Functional Health Literacy in Adults | 33.5 units on a scale STANDARD_DEVIATION 3.5 | 32.9 units on a scale STANDARD_DEVIATION 5 | 32.3 units on a scale STANDARD_DEVIATION 6 |
| Site Ann Arbor VAMC, Ann Arbor, MI | 38 Participants | 75 Participants | 37 Participants |
| Site James J. Peters VAMC, Bronx, NY | 52 Participants | 105 Participants | 53 Participants |
| Systolic Blood Pressure | 131.8 mmHg STANDARD_DEVIATION 17.7 | 132.7 mmHg STANDARD_DEVIATION 18.2 | 133.5 mmHg STANDARD_DEVIATION 18.7 |
| Years of Education | 14.3 years STANDARD_DEVIATION 2.7 | 14.3 years STANDARD_DEVIATION 2.5 | 14.4 years STANDARD_DEVIATION 2.3 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 90 | 3 / 90 |
| other Total, other adverse events | 0 / 90 | 0 / 90 |
| serious Total, serious adverse events | 4 / 90 | 6 / 90 |
Outcome results
Primary
Diabetes Self-management
The data below represent values of the Diabetes Self-Management Questionnaire (DSMQ) scores at 6 months post-intervention, the primary outcome. DSMQ scores range from 0 to 20, with higher scores indicating better self-management, the same as baseline.
Time frame: 6 months after the intervention
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive CCT | Diabetes Self-management | 14.9 score on a scale | Standard Deviation 2.4 |
| Active Control | Diabetes Self-management | 15.1 score on a scale | Standard Deviation 2.5 |
Secondary
Diastolic Blood Pressure
A measure of the extent of pressure of the blood in the arteries when the heart is filling, assessed using a blood pressure cuff. Higher values indicate worse outcome. The data below represent outcome values at 6 months.
Time frame: assessed 6 months after intervention
Population: Omron HEM-780 blood pressure device not available for 1 adaptive CCT and 2 active control participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive CCT | Diastolic Blood Pressure | 74.38 mmHg | Standard Deviation 10.45 |
| Active Control | Diastolic Blood Pressure | 69.77 mmHg | Standard Deviation 11.01 |
Secondary
Executive Function/Attention
As with baseline attention/executive function score, the outcome score was the mean of the Target Cancellation (TMX, Diamond), Trail Making (A, B; reversed), Digit Symbol Substitution, and, Digit Span (Forward, Backward) tasks after conversion to a common unit of measurement. However, to standardize these outcome tasks, the statistics from which the baseline z-scores were calculated (mean\_baseline and SD\_baseline from the full sample before randomization) were used, rather than the means of the given outcome period: standardized score = (outcome task score - mean\_baseline) / SD\_baseline. Thus, while baseline task scores were conventional z-scores, the six-month post-intervention standardized scores were not, in order to best inform the outcome measure and better facilitate comparison with baseline. The data below represent outcome values at 6 months. Like the baseline measure, this measure does not have a theoretical minimum or maximum, and higher scores indicate better performance.
Time frame: 6 months after the intervention
Population: Two active control participants did not complete neuropsychological test battery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive CCT | Executive Function/Attention | 0.288 units on a scale | Standard Deviation 0.628 |
| Active Control | Executive Function/Attention | 0.327 units on a scale | Standard Deviation 0.531 |
Secondary
Hemoglobin A1c
A measure of glycemic control derived from blood sample. The data below represent outcome values at 6 months. Higher values represent poorer control of glycation.
Time frame: 6 months after the intervention
Population: Siemens HbA1c machine was unavailable for 2 adaptive CCT and 1 active control participant.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive CCT | Hemoglobin A1c | 7.58 percentage of hemoglobin glycation | Standard Deviation 1.68 |
| Active Control | Hemoglobin A1c | 7.50 percentage of hemoglobin glycation | Standard Deviation 1.4 |
Secondary
Medication Adherence
Medication adherence was assessed by the Continuous Multiple interval measure of Gaps in therapy (CMG), using diabetes medication refill data from the CPRS for the full year post-intervention. To calculate CMG percentage, the total number of days without medication refills when due - refill gap-days - was divided by 365, the days in a year. Multiplying this fraction by 100 provides the CMG percentage, where a higher percentage indicates worse medication adherence. The data below represent the CMG percentage at 12 months post-intervention.
Time frame: 12 months post-intervention
Population: Some participants did not use VA pharmacy for medication reducing samples in groups.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive CCT | Medication Adherence | 0.11 percentage of refill gap-days | Standard Deviation 0.1 |
| Active Control | Medication Adherence | 0.14 percentage of refill gap-days | Standard Deviation 0.11 |
Secondary
Memory
As with baseline memory score, the outcome score was the mean of Word List Memory and Logical Memory (Story A) tests, each providing three scores: immediate recall, delayed recall, and recognition tasks after conversion to a common unit of measurement. However, to standardize these outcome tasks, the statistics from which the baseline z-scores were calculated (mean\_baseline and SD\_baseline from the full sample before randomization) were used, rather than the means of the given outcome period: standardized score = (outcome task score - mean\_baseline) / SD\_baseline. Thus, while baseline task scores were conventional z-scores, the six-month post-intervention standardized scores were not, in order to best inform the outcome measure and better facilitate comparison with baseline. The data below represent outcome values at 6 months. Like the baseline measure, this measure does not have a theoretical minimum or maximum, and higher scores indicate better performance.
Time frame: 6 month after the intervention
Population: Two active control participants did not complete neuropsychological test battery.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive CCT | Memory | 0.652 units on a scale | Standard Deviation 0.594 |
| Active Control | Memory | 0.460 units on a scale | Standard Deviation 0.738 |
Secondary
Prospective Memory
The Appointments - Delayed Recall subtest of the Rivermead Behavioral Memory Test - Third Edition (RBMT - 3) is a test of prospective memory - remembering to do something in the future. The examinee was instructed to ask two questions when an alarm rings 25 minutes later. For each question, a score of 2 was given when a participant responded without requiring a prompt, 1 point when a prompt was needed and elicited a correct response, and 0 when there was no appropriate response despite prompting. Scores were summed and the total score ranges from 0 to 4. Higher scores indicate better performance. The data below represent outcome values at 6 months.
Time frame: 6 months after the intervention
Population: Test not administered to 5 participants (4 adaptive CCT and 1 active control).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive CCT | Prospective Memory | 3.47 score on a scale | Standard Deviation 0.77 |
| Active Control | Prospective Memory | 3.40 score on a scale | Standard Deviation 0.9 |
Secondary
Systolic Blood Pressure
A measure of the extent of pressure that blood is exerting against an individual's artery walls when the heart beats, assessed using a blood pressure cuff. Higher values indicate worse outcome. The data below represent outcome values at 6 months.
Time frame: 6 months after the intervention
Population: Omron HEM-780 blood pressure device not available for 1 adaptive CCT and 2 active control participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Adaptive CCT | Systolic Blood Pressure | 129.82 mmHg | Standard Deviation 14.21 |
| Active Control | Systolic Blood Pressure | 125.99 mmHg | Standard Deviation 16.13 |