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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Computerized Cognitive Training (CCT) | Experimental | Randomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits. |
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| Active control | Active Comparator | Randomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| computerized cognitive training | Other | A variety of computer games tailored to address their personal cognitive deficits. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months after the intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Silverman, PhD | James J. Peters Veterans Affairs Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| James J. Peters VA Medical Center, Bronx, NY | The Bronx | New York | 10468-3904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31006684 | Background | Karran M, Guerrero-Berroa E, Schmeidler J, Lee PG, Alexander N, Nabozny M, West RK, Beeri MS, Sano M, Silverman JM. Recruitment of Older Veterans with Diabetes Risk for Alzheimer's Disease for a Randomized Clinical Trial of Computerized Cognitive Training. J Alzheimers Dis. 2019;69(2):401-411. doi: 10.3233/JAD-180952. | |
| 31890856 |
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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
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
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| ID | Title | Description |
|---|---|---|
| FG000 | Computerized Cognitive Training (CCT) | Randomly selected subjects perform a variety of computer games tailored to address their personal cognitive deficits. computerized cognitive training: A variety of computer games tailored to address their personal cognitive deficits. |
| FG001 | Active Control | Randomly selected subjects perform a variety of computer games that are engaging but not designed to enhance cognitive skills. control games: A variety of computer games that are engaging but not designed to enhance cognitive skills |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline |
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| Post-intervention Assessment |
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| 6 Mo. Post-Intervention Assessment |
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| 12 Mo. Post-Intervention Assessment |
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Participants included in data had evidence of less than optimal diabetes self-management
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 6 months after the intervention |
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The time period for each subject's participation was approximately 14.5 months. The initial baseline assessment (1 to 2 days) was followed by 8 weeks of adaptive CCT/active control activity. Participants were then assessed immediately after the intervention, and at 6 and 12 months post-intervention.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Surgery | Gastrointestinal disorders | Non-systematic Assessment | Scheduled surgery on stomach. Participants were not withdrawn from the study.. |
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Attrition of subjects was greater among minorities, Bronx site, CDR=0.5 ("questionable dementia"), lower (worse) MMSE and worse health literacy. Rates of attrition by these and all other covariates measured did not differ between intervention groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jeremy Silverman | James J. Peters Veterans Affairs Medical Center | 718-584-9000 | 1700 | jeremy.silverman@va.gov; jeremy.silverman@mssm.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 6, 2017 | Aug 27, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2020 | Aug 27, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003704 | Dementia |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| control games | Other | A variety of computer games that are engaging but not designed to enhance cognitive skills |
|
| 12 months post-intervention |
| 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. | 6 month after the intervention |
| 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. | 6 months after the intervention |
| 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. | 6 months after the intervention |
| 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. | 6 months after the intervention |
| 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. | assessed 6 months after intervention |
| 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. | 6 months after the intervention |
| Silverman JM, Schmeidler J, Lee PG, Alexander NB, Beeri MS, Guerrero-Berroa E, West RK, Sano M, Nabozny M, Rodriguez Alvarez C. Associations of hemoglobin A1c with cognition reduced for long diabetes duration. Alzheimers Dement (N Y). 2019 Dec 11;5:926-932. doi: 10.1016/j.trci.2019.11.009. eCollection 2019. |
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| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Years of Education | Years of education. | Mean | Standard Deviation | years |
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| Site | Count of Participants | Participants |
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| Clinical Dementia Rating (CDR) Scale | The Clinical Dementia Rating Scale is a scale used to determine the presence of a dementia and, if present, quantify the severity of symptoms (its "stage"), Possible scores are: 0 ("no dementia"), 0.5 ("questionable dementia"), 1 ("mild dementia"), 2 ("moderate dementia") and 3 ("severe dementia"). All scores greater than 0.5 were exclusions. | Count of Participants | Participants |
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| Mini-Mental Status Exam (MMSE) | Participation required a score of 25 or greater, from a possible range of 0 to 30, at baseline. High scores indicated better global cognition. | Mean | Standard Deviation | units on a scale |
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| Diabetes Self-Management Questionnaire (DSMQ) | Primary Outcome: 0-20 scale with high scores indicating better self-management. Administered to the participant and his or her informant and the average of these was used.. Eligibility required a baseline score < or = 18, indicating less than optimal self-management. | Mean | Standard Deviation | units on a scale |
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| Hemoglobin A1c (HbA1c) | 4 participants missing HBA1c | Mean | Standard Deviation | percentage of glycosylated hemoglobin |
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| Systolic Blood Pressure | 4 participants were missing on this measure | Mean | Standard Deviation | mmHg |
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| Diastolic Blood Pressure | 4 participants were missing on this measure | Mean | Standard Deviation | mmHg |
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| Memory Score | This measure of "memory" combined 6 tests: immediate recall, delayed recall, and recognition, from both Word List Memory and Logical Memory (Story A) tests. Before randomization for each test, mean_baseline and SD_baseline were calculated. In each group after randomization, a participant's baseline scores was the average of test z-scores, (participant score -mean_baseline)/ SD_baseline. Higher score indicates better performance with the same unit of measurement in both groups. | For analysis, memory was calculated only for participants with at least 14 of 16 neuropsychological test scores (169 at baseline). Non-missing scores of each memory test were converted to z-scores and averaged for the participant. | Mean | Standard Deviation | average of z-scores |
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| Attention/Executive Functions | This measure of "attention/executive functions" combined 7 tests: Trail Making Test (A, B; reversed), Target Cancellation (TMX, Diamond), Digit Symbol Substitution and Digit Span (Forward, Backward) tests. Before randomization for each test, mean_baseline and SD_baseline were calculated. In each group after randomization, a participant's baseline scores was the average of test z-scores, (participant score -mean_baseline)/ SD_baseline. Higher score indicates better performance with the same unit of measurement in both groups. | For analysis, attention/executive functions was calculated only for participants with at least 14 of 16 neuropsychological test scores (169 at baseline). Non-missing scores of each attention/executive function test were converted to z-scores and averaged for the participant. | Mean | Standard Deviation | average of z-scores |
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| Rivermead Behavioral Memory Prospective Memory (Appointments Subtest) | 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 is instructed to ask two questions when an alarm rings 25 minutes after describing what is needed. For each question, a score of 2 is given when a participant responds without requiring a prompt, 1 point when a prompt is needed, and 0 when there is no appropriate response despite prompting. Scores are summed and the total score ranges from 0 to 4. Higher scores indicate better performance. | 12 participants were missing on this assessment. | Mean | Standard Deviation | units on a scale |
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| Medication Adherence | Medication adherence was assessed by the Continuous Multiple interval measure of Gaps in therapy (CMG), using diabetes medication refill data from the Computerized Patient Record System (CPRS). To calculate CMG percentage, the total number of days in treatment gaps (refill gap-days) was divided by the total number of days within the time period of interest (here, 365 days, one year). Multiplying this fraction by 100 provide the CMG percentage, where higher a percentage indicates worse medication adherence. | Medication data was derived from the VA's Computerized Patient Record System (CPRS). Not all participants obtained their medications from the VA. | Mean | Standard Deviation | percentage of refill gap-days per year |
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| Cognitive Self-Report Questionnaire (CSRQ) | Subjective cognition measure. The CSRQ.assesses 25 perceptions of cognitive abilities and mood in everyday life over the past two weeks, answered using a 0 to 5 point Likert scale ("Almost Always," "Often/Usually." "Sometimes," "Seldom," "Hardly Ever," and "Does not apply to me" [which always corresponds to a score of 0]). Possible scores range from 0 to 125, where a lower total score indicates better self-perceived cognition (125 max score indicating worst self-report cognition). | Not all participants completed this assessment. | Mean | Standard Deviation | units on a scale |
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| Geriatric Depression Scale | The Geriatric Depression Scale (GDS) is a self-report assessment with 30 items used to identify levels of depression in the elderly. Each of the 30 items (features associated with depression) are scored 0 if absent and 1 if present to obtain a total score that can range from 0 to 30. Higher scores indicate higher levels of depression. | Not all participants completed this assessment. | Mean | Standard Deviation | units on a scale |
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| Short -Test of Functional Health Literacy in Adults | This test measures the ability to obtain, read, understand, and use healthcare information in order to make appropriate health decisions and follow instructions for treatment. There are two sections of the test: reading comprehension involving 2 passages and 36 items each worth 2 points (with scores ranging from 0 to 72); and, numeracy involving 4 items each worth 7 points (with scores ranging from 0 to 28). This randomized control trial (RCT) used total scores (range: 0 to 100), with higher scores indicating better health literacy. | Mean | Standard Deviation | units on a scale |
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| 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. | Some participants did not use VA pharmacy for medication reducing samples in groups. | Posted | Mean | Standard Deviation | percentage of refill gap-days | 12 months post-intervention |
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| 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. | Two active control participants did not complete neuropsychological test battery. | Posted | Mean | Standard Deviation | units on a scale | 6 month after the intervention |
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| 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. | Two active control participants did not complete neuropsychological test battery. | Posted | Mean | Standard Deviation | units on a scale | 6 months after the intervention |
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| 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. | Siemens HbA1c machine was unavailable for 2 adaptive CCT and 1 active control participant. | Posted | Mean | Standard Deviation | percentage of hemoglobin glycation | 6 months after the intervention |
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| 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. | Omron HEM-780 blood pressure device not available for 1 adaptive CCT and 2 active control participants. | Posted | Mean | Standard Deviation | mmHg | 6 months after the intervention |
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| 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. | Omron HEM-780 blood pressure device not available for 1 adaptive CCT and 2 active control participants. | Posted | Mean | Standard Deviation | mmHg | assessed 6 months after intervention |
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| 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. | Test not administered to 5 participants (4 adaptive CCT and 1 active control). | Posted | Mean | Standard Deviation | score on a scale | 6 months after the intervention |
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| 3 |
| 90 |
| 4 |
| 90 |
| 0 |
| 90 |
| EG001 | 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. | 3 | 90 | 6 | 90 | 0 | 90 |
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| Stroke | Nervous system disorders | Non-systematic Assessment | Pt suffered a mild stroke and was hospitalized. Pt was withdrawn from the study |
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| Surgery | Immune system disorders | Non-systematic Assessment | Participant had scheduled surgery related to gout and was not withdrawn from the study. |
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| Death | General disorders | Non-systematic Assessment | death reported by relative in phone contact |
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| D004700 | Endocrine System Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003072 | Cognition Disorders |
| Hispanic |
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| other/unknown |
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