An interventional study of Brain Safe App and Attention Control App in Alzheimer Disease and Dementia, sponsored by Indiana University. Completed at 2 sites in United States. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2026-07-20.
Sponsored by Indiana University · Not applicable, Interventional, and Prevention
This study is an RCT to evaluate the effectiveness of Brain Safe on reducing anticholinergic exposure. Over 42 months, the trial will enroll 700 community-dwelling older adults who were prescribed one or more strong anticholinergics. Participants will be randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders.
This study is a randomized clinical trial (RCT) of the efficacy of a direct-to-consumer intervention called Brain Safe to primarily reduce older adults' exposure to prescription anticholinergics and secondarily improve cognitive function and health-related quality of life. Over 42 months, the trial will enroll 700 community-dwelling older adults who were prescribed one or more strong anticholinergics. Participants will be randomized to use the Brain Safe app or an attention control medication list app for 12 months, with monthly usage reminders.
The primary objective is to test the effect of Brain Safe on anticholinergic exposure at 12 months. We hypothesize that anticholinergic exposure will be lower among those randomized to the Brain Safe intervention compared to those randomized to the attention control app at 12 months. Our primary, powered outcome is the total standard daily dose (TSDD) measure of anticholinergic exposure at 12 months, which is calculated over the preceding 6 months of prescription data. We will electronically capture prescription data monthly and compute TSDD at baseline, 6, and 12 months.
The secondary objective is to test the effect of Brain Safe on: (a) cognitive function and (b) health-related quality of life at 12 months. We hypothesize older adults randomized to Brain Safe will have higher (a) cognitive function, measured by using an objective, performance-based composite, and (b) health-related quality of life (HRQOL), compared to those randomized to the attention control app, at 12 months.
Exploratory objectives are to test the effect of Brain Safe on anticholinergic exposure, cognitive function, and HRQOL at 6 months. This aim will explore the presence of early effects of Brain Safe at 6 months.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 706 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Indiana University is the lead sponsor of 958 studies on the registry; 200 are open to participants now.
Of its 142 completed or terminated interventional studies of FDA-regulated products, 112 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1)Brain Safe App provides conversation starters for older adult patients on target anticholinergics. The conversation starters assist the patient to have discussions with their physicians regarding reduction in exposure to prescription anticholinergics. 2) Provides anticholinergic risk assessment.
Other: Brain Safe App
1\) Attention Control App provides a medication list for older patients to use but lacks the conversation starters for patient to use with there physicians aimed at reduction in exposure to prescription anticholinergics.2) No anticholinergic risk assessment.
Other: Attention Control App
The Brain Safe app includes the medication list, a personalized risk calculator, multimedia educational content, and a conversation starter/doctor's report.
The attention control app, called Med Safe, includes only the medication list feature.
Total Standardized Daily Dose (TSDD) - From Medical Records
To calculate the Total Standardized Daily Dose (TSDD), we first calculated the Standardized Daily Dose (SDD) for each anticholinergic medication with an ACB Score of 2 or 3. SDD was calculated by multiplying the strength by the units per dose and frequency per day and number of refills. The product was divided by the minimum effective daily dose (where available) or the minimum effective geriatric dose to standardize the quantity across multiple classes of medications. The SDD for all anticholinergics with an ACB score 2 or 3 was then summed for each participant for each 6-month period, and divided by the number of days in the relevant six month period to arrive at a TSDD. Range: The minimum possible value is 0 (optimal outcome; indicating zero exposure to ACB 2 or 3 medications). There is no fixed theoretical maximum score(higher value more exposure), as the upper limit is mathematically determined by the total volume and combination of medications a participant is prescribed.
Time frame: Baseline, 6 months, 12 Months
Log Transformed Total Standardized Daily Dose (TSDD) - From Medical Records
Construct: Measures natural log-transformed average daily exposure to medications with an Anticholinergic Cognitive Burden (ACB) score of 2 or 3 to normalize data distribution.How Computed: Medication Standardized Daily Dose (SDD) = (strength × units/dose × frequency/day × refills) / minimum effective daily or geriatric dose. The SDD for all eligible drugs is summed over 6 months, divided by the number of days in that period to find raw TSDD, and natural log-transformed ($\\ln(x+1)$ or similar) for the final score.Scale Range: Minimum value is 0 (representing 0 raw TSDD, or zero exposure). There is no fixed theoretical maximum, as it is mathematically determined by the volume of medications prescribed.Interpretation: A value of 0 is the optimal outcome (no exposure). Higher values represent greater exposure (worse outcome).
Time frame: Baseline, 6, and 12 Months
Overall Cognitive Score
An overall cognitive score evaluating three domains: memory/new learning, executive function, and processing speed. Calculated by taking the mean of standardized Z-scores from the following specific tests: Hopkins Verbal Learning Test-Revised (HVLT-R) total and delayed recall; Trail Making Test Parts A and B; Phonetic Fluency; Semantic Fluency (adjusted); and Symbol Digit Modalities Test (correct). A Z-score of 0 represents the baseline study population mean. Standardized scores theoretically range from -3.0 to +3.0. Higher positive Z-scores (standard deviations above the mean) represent better cognitive performance (better outcome). Lower negative Z-scores represent worse cognitive performance (worse outcome). No clinical threshold is defined. Z-scores were derived using baseline means, with timed tests (e.g., Trails) inverted prior to averaging so higher always means better performance.
Time frame: Baseline, 6 months, and 12 months
Choice Reaction Time (CRT)
Computer-based assessment of Choice Reaction Time (CRT). It is used to evaluate executive function, attention, and psychomotor speed by measuring the time elapsed between the presentation of one of multiple possible stimuli and the participant's correct response. The final score represents the average response time (in milliseconds/seconds) across all valid test trials. The minimum value is 0. There is no fixed theoretical maximum, as the upper limit is bounded only by the participant's maximum delay. Lower values represent faster reaction times, indicating better executive functioning and psychomotor speed (a better outcome). Higher values indicate slower reaction times (a worse outcome).
Time frame: Baseline
Health Utilities Index (HUI) Mark 3
The Health Utilities Index Mark 3 (HUI3) is a self-reported, multi-attribute health status classification system used to measure overall health-related quality of life and functional capacity. The score is calculated using responses across eight dimensions of health (vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain). These subscales are combined using a mathematically weighted scoring algorithm to compute a single total utility index score. The total utility score ranges from a minimum of -0.36 (representing a health state considered worse than death) to a maximum of 1.00 (representing perfect health). A score of 0.00 represents death. Higher values represent a better health-related quality of life (a better outcome). Lower values represent worse health status (a worse outcome).
Time frame: Baseline, 6 months, and 12 months
Hopkins Verbal Learning Test (HVLT) Total Recall
Hopkins Verbal Learning Test (HVLT) Total Recall. It is a paper-based list learning and recall assessment used to evaluate verbal memory and new learning capacity. Participants are read a list of 12 words and asked to freely recall as many as possible across three consecutive learning trials. The total recall score is calculated by summing the number of correctly recalled words across all three trials. The total recall score ranges from a minimum of 0 to a maximum of 36. Higher values represent a greater number of words correctly recalled, indicating better memory and verbal learning function (a better outcome). Lower scores indicate worse memory function (a worse outcome).
Time frame: Baseline, 6 months, and 12 months
Hopkins Verbal Learning Test (HVLT) Delayed Recall
Hopkins Verbal Learning Test (HVLT) Delayed Recall. It is a paper-based assessment used to evaluate delayed verbal memory retention and recall capacity. After a standard delay interval (typically 20 to 25 minutes) following the initial learning trials, participants are asked to freely recall the original list of 12 words. The delayed recall score is the total number of words correctly recalled from memory. The score ranges from a minimum of 0 to a maximum of 12. Higher values represent a greater number of words retained and recalled after the delay, indicating better memory retention (a better outcome). Lower scores indicate worse memory retention (a worse outcome).
Time frame: Baseline, 6 months, 12 months
Trail Making Test (TMT) Parts A
Number Correct Line Segments. This is a performance-based metric derived from the Trail Making Test (TMT) used to assess visual search, scanning, processing speed, and executive function, particularly when a participant is unable to complete the full timed test. The score is calculated by counting the total number of correct line segments a participant successfully draws connecting the sequences of encircled numbers (or numbers and letters) within the allotted test parameters. The score ranges from a minimum of 0 to a maximum of 25. Higher values represent a greater number of correctly drawn segments, indicating better cognitive processing speed and executive functioning (a better outcome). Lower values indicate worse cognitive performance (a worse outcome).
Time frame: Baseline, 6 months, and 12 months
Trail Making Test (TMT) Parts B
Number Correct Line Segments (TMT Part B). This is a performance-based metric derived from the Trail Making Test Part B used to assess executive function, cognitive flexibility, and visual-motor tracking. It is particularly useful for quantifying performance when a participant is unable to complete the full timed test. The score is calculated by counting the total number of correct line segments a participant successfully draws connecting the 25 encircled numbers and letters in an alternating sequence (1, A, 2, B, 3, C...) within the allotted test parameters. The score ranges from a minimum of 0 to a maximum of 25. Higher values represent a greater number of correctly drawn segments, indicating better cognitive flexibility and executive functioning (a better outcome). Lower values indicate worse cognitive performance (a worse outcome).
Time frame: Baseline, 6 months, and 12 months
Digit-Symbol Substitution Test (DSST) Number of Correct Responses
Digit-Symbol Substitution Test (DSST), utilizing the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding subtest. It is a paper-based assessment used to evaluate processing speed, visual-motor coordination, and sustained attention. Participants are provided a key pairing numbers (1 through 9) with simple geometric symbols. They are given a strict time limit (120 seconds) to draw the correct corresponding symbols beneath a series of randomized numbers. The final score is the total number of correctly drawn symbols within the time limit. The score ranges from a minimum of 0 to a maximum of 135 (the maximum possible items on the WAIS-IV Coding form). Higher values represent a greater number of correctly matched symbols, indicating faster processing speed and better cognitive performance (a better outcome). Lower scores indicate slower processing speed (a worse outcome).
Time frame: Baseline, 6 months, and 12 months
Medication Perceptions
Medication Perceptions Questionnaire. It is a 9-item survey developed in-house (adapted from Health Belief Model constructs and the revised Patients' Attitudes Towards Deprescribing Questionnaire) to assess participants' beliefs and attitudes regarding their medications and deprescribing. Participants rate items on a 5-point Likert agreement scale. The final score is calculated as a subscale average of the answered items (which allows for missing data if a participant skipped a question). The subscale average score ranges from a minimum of 1 to a maximum of 5. Higher scores indicate more disagreement (less agreement) with the survey statements. Lower scores indicate stronger agreement. The clinical favorability (better/worse outcome) depends on the specific construct of the subscale statement.
Time frame: 12 months
Self-reported Deprescribing Behavior
The Self-Reported Deprescribing Behavior Survey is an in-house, 4-item questionnaire designed to assess a participant's self-reported actions and behaviors related to stopping or reducing their medications (deprescribing). Item Scoring: Participants rate each of the 4 items individually using a 5-point Likert scale (1 = Strongly Agree, 5 = Strongly Disagree). Score Generation: The scores of the 4 individual items are mathematically averaged to calculate a single overall composite score. Scale Range: The overall composite average score ranges from a minimum of 1 to a maximum of 5. Outcome Direction: Lower overall average values (closer to 1) indicate stronger agreement with active deprescribing behaviors, which represents a better clinical outcome. Higher overall average values (closer to 5) indicate greater disagreement, which represents a worse clinical outcome.
Time frame: 12 months
Technology Use-
Proportion of months out of the total study time the participant logged into the application at least once.
Time frame: 12 months
| Milestone | Brain Safe App | Attention Control App |
|---|---|---|
| Started | 342 | 343 |
| 6 month | 278 | 269 |
| 12 month | 251 | 240 |
| Primary outcome | 297 | 293 |
| Completed | 251 | 240 |
| Not completed | 91 | 103 |
| Withdrew: Lost to follow-up | 46 | 53 |
| Withdrew: Withdrawal by subject | 40 | 41 |
| Withdrew: Death | 3 | 7 |
| Withdrew: No longer eligible | 2 | 2 |
To calculate the Total Standardized Daily Dose (TSDD), we first calculated the Standardized Daily Dose (SDD) for each anticholinergic medication with an ACB Score of 2 or 3. SDD was calculated by multiplying the strength by the units per dose and frequency per day and number of refills. The product was divided by the minimum effective daily dose (where available) or the minimum effective geriatric dose to standardize the quantity across multiple classes of medications. The SDD for all anticholinergics with an ACB score 2 or 3 was then summed for each participant for each 6-month period, and divided by the number of days in the relevant six month period to arrive at a TSDD. Range: The minimum possible value is 0 (optimal outcome; indicating zero exposure to ACB 2 or 3 medications). There is no fixed theoretical maximum score(higher value more exposure), as the upper limit is mathematically determined by the total volume and combination of medications a participant is prescribed.
| Standardized Doses Per Day | Brain Safe App | Attention Control App |
|---|---|---|
| Baseline | 1.59 ± 3.04 | 1.68 ± 3.57 |
| 6 Months | 0.86 ± 1.61 | 1.19 ± 3.53 |
| 12 Month | 1.27 ± 2.51 | 1.29 ± 3.18 |
An overall cognitive score evaluating three domains: memory/new learning, executive function, and processing speed. Calculated by taking the mean of standardized Z-scores from the following specific tests: Hopkins Verbal Learning Test-Revised (HVLT-R) total and delayed recall; Trail Making Test Parts A and B; Phonetic Fluency; Semantic Fluency (adjusted); and Symbol Digit Modalities Test (correct). A Z-score of 0 represents the baseline study population mean. Standardized scores theoretically range from -3.0 to +3.0. Higher positive Z-scores (standard deviations above the mean) represent better cognitive performance (better outcome). Lower negative Z-scores represent worse cognitive performance (worse outcome). No clinical threshold is defined. Z-scores were derived using baseline means, with timed tests (e.g., Trails) inverted prior to averaging so higher always means better performance.
| Z-Scores | Brain Safe App | Attention Control App |
|---|---|---|
| Baseline | -0.01 ± 0.61 | -0.02 ± 0.58 |
| 6 Months | -0.09 ± 0.51 | -0.12 ± 0.55 |
| 12 Month | -0.05 ± 0.50 | -0.10 ± 0.61 |
Computer-based assessment of Choice Reaction Time (CRT). It is used to evaluate executive function, attention, and psychomotor speed by measuring the time elapsed between the presentation of one of multiple possible stimuli and the participant's correct response. The final score represents the average response time (in milliseconds/seconds) across all valid test trials. The minimum value is 0. There is no fixed theoretical maximum, as the upper limit is bounded only by the participant's maximum delay. Lower values represent faster reaction times, indicating better executive functioning and psychomotor speed (a better outcome). Higher values indicate slower reaction times (a worse outcome).
| Average Response Time (Seconds) | Brain Safe App | Attention Control App |
|---|---|---|
| Choice Reaction Time (CRT) | 59.58 ± 15.83 | 52.86 ± 19.78 |
The Health Utilities Index Mark 3 (HUI3) is a self-reported, multi-attribute health status classification system used to measure overall health-related quality of life and functional capacity. The score is calculated using responses across eight dimensions of health (vision, hearing, speech, ambulation, dexterity, emotion, cognition, and pain). These subscales are combined using a mathematically weighted scoring algorithm to compute a single total utility index score. The total utility score ranges from a minimum of -0.36 (representing a health state considered worse than death) to a maximum of 1.00 (representing perfect health). A score of 0.00 represents death. Higher values represent a better health-related quality of life (a better outcome). Lower values represent worse health status (a worse outcome).
| Score on a Scale | Brain Safe App | Attention Control App |
|---|---|---|
| Baseline | 0.63 ± 0.31 | 0.63 ± 0.32 |
| 6 Months | 0.61 ± 0.31 | 0.60 ± 0.31 |
| 12 Month | 0.60 ± 0.33 | 0.63 ± 0.31 |
Hopkins Verbal Learning Test (HVLT) Total Recall. It is a paper-based list learning and recall assessment used to evaluate verbal memory and new learning capacity. Participants are read a list of 12 words and asked to freely recall as many as possible across three consecutive learning trials. The total recall score is calculated by summing the number of correctly recalled words across all three trials. The total recall score ranges from a minimum of 0 to a maximum of 36. Higher values represent a greater number of words correctly recalled, indicating better memory and verbal learning function (a better outcome). Lower scores indicate worse memory function (a worse outcome).
| Raw Score | Brain Safe App | Attention Control App |
|---|---|---|
| Baseline | 26.36 ± 5.58 | 26.01 ± 5.44 |
| 6 Months | 26.18 ± 5.24 | 25.35 ± 5.24 |
| 12 Month | 26.71 ± 5.35 | 26.49 ± 5.51 |
Hopkins Verbal Learning Test (HVLT) Delayed Recall. It is a paper-based assessment used to evaluate delayed verbal memory retention and recall capacity. After a standard delay interval (typically 20 to 25 minutes) following the initial learning trials, participants are asked to freely recall the original list of 12 words. The delayed recall score is the total number of words correctly recalled from memory. The score ranges from a minimum of 0 to a maximum of 12. Higher values represent a greater number of words retained and recalled after the delay, indicating better memory retention (a better outcome). Lower scores indicate worse memory retention (a worse outcome).
| Raw Score | Brain Safe App | Attention Control App |
|---|---|---|
| Baseline | 9.27 ± 2.38 | 9.00 ± 2.64 |
| 6 Months | 9.06 ± 2.41 | 8.65 ± 2.62 |
| 12 Month | 9.22 ± 2.45 | 8.96 ± 2.62 |
Medication Perceptions Questionnaire. It is a 9-item survey developed in-house (adapted from Health Belief Model constructs and the revised Patients' Attitudes Towards Deprescribing Questionnaire) to assess participants' beliefs and attitudes regarding their medications and deprescribing. Participants rate items on a 5-point Likert agreement scale. The final score is calculated as a subscale average of the answered items (which allows for missing data if a participant skipped a question). The subscale average score ranges from a minimum of 1 to a maximum of 5. Higher scores indicate more disagreement (less agreement) with the survey statements. Lower scores indicate stronger agreement. The clinical favorability (better/worse outcome) depends on the specific construct of the subscale statement.
| Scores on a Scale | Brain Safe App | Attention Control App |
|---|---|---|
| Threat awareness-susceptibility: If I regularly take certain medications... | 3.4 ± 1.0 | 3.3 ± 0.9 |
| Perceived deprescribing benefit: If I stop taking certain medications... | 3.1 ± 0.8 | 3.0 ± 0.9 |
| Perceived deprescribing barriers: When I think about changing my medications... | 3.0 ± 0.8 | 3.0 ± 0.9 |
| Perceived self-efficacy: When I think about my medications... | 2.1 ± 0.7 | 2.2 ± 0.7 |
| Cues to action: When I think about my medications... | 1.9 ± 0.7 | 1.9 ± 0.7 |
The Self-Reported Deprescribing Behavior Survey is an in-house, 4-item questionnaire designed to assess a participant's self-reported actions and behaviors related to stopping or reducing their medications (deprescribing). Item Scoring: Participants rate each of the 4 items individually using a 5-point Likert scale (1 = Strongly Agree, 5 = Strongly Disagree). Score Generation: The scores of the 4 individual items are mathematically averaged to calculate a single overall composite score. Scale Range: The overall composite average score ranges from a minimum of 1 to a maximum of 5. Outcome Direction: Lower overall average values (closer to 1) indicate stronger agreement with active deprescribing behaviors, which represents a better clinical outcome. Higher overall average values (closer to 5) indicate greater disagreement, which represents a worse clinical outcome.
| Scores on a Scale | Brain Safe App | Attention Control App |
|---|---|---|
| Self-reported Deprescribing Behavior | 3.2 ± 0.8 | 3.3 ± 0.8 |
Proportion of months out of the total study time the participant logged into the application at least once.
| Proportion of Months | Brain Safe App | Attention Control App |
|---|---|---|
| Technology Use- | 0.36 ± 0.29 | 0.34 ± 0.29 |
Construct: Measures natural log-transformed average daily exposure to medications with an Anticholinergic Cognitive Burden (ACB) score of 2 or 3 to normalize data distribution.How Computed: Medication Standardized Daily Dose (SDD) = (strength × units/dose × frequency/day × refills) / minimum effective daily or geriatric dose. The SDD for all eligible drugs is summed over 6 months, divided by the number of days in that period to find raw TSDD, and natural log-transformed ($\\ln(x+1)$ or similar) for the final score.Scale Range: Minimum value is 0 (representing 0 raw TSDD, or zero exposure). There is no fixed theoretical maximum, as it is mathematically determined by the volume of medications prescribed.Interpretation: A value of 0 is the optimal outcome (no exposure). Higher values represent greater exposure (worse outcome).
| ln(doses per day) | Brain Safe App | Attention Control App |
|---|---|---|
| Baseline | -0.93 ± 2.45 | -1.12 ± 2.70 |
| 6 Months | -3.32 ± 3.50 | -3.01 ± 3.52 |
| 12 Month | -3.04 ± 3.68 | -2.69 ± 3.59 |
Number Correct Line Segments. This is a performance-based metric derived from the Trail Making Test (TMT) used to assess visual search, scanning, processing speed, and executive function, particularly when a participant is unable to complete the full timed test. The score is calculated by counting the total number of correct line segments a participant successfully draws connecting the sequences of encircled numbers (or numbers and letters) within the allotted test parameters. The score ranges from a minimum of 0 to a maximum of 25. Higher values represent a greater number of correctly drawn segments, indicating better cognitive processing speed and executive functioning (a better outcome). Lower values indicate worse cognitive performance (a worse outcome).
| Number Correct Line Segments | Brain Safe App | Attention Control App |
|---|---|---|
| Baseline | 24.91 ± 1.36 | 24.96 ± 0.29 |
| 6 Months | 25 ± 0 | 25 ± 0 |
| 12 Month | 25.00 ± 0 | 24.94 ± 0.91 |
Number Correct Line Segments (TMT Part B). This is a performance-based metric derived from the Trail Making Test Part B used to assess executive function, cognitive flexibility, and visual-motor tracking. It is particularly useful for quantifying performance when a participant is unable to complete the full timed test. The score is calculated by counting the total number of correct line segments a participant successfully draws connecting the 25 encircled numbers and letters in an alternating sequence (1, A, 2, B, 3, C...) within the allotted test parameters. The score ranges from a minimum of 0 to a maximum of 25. Higher values represent a greater number of correctly drawn segments, indicating better cognitive flexibility and executive functioning (a better outcome). Lower values indicate worse cognitive performance (a worse outcome).
| Number Correct Line Segments | Brain Safe App | Attention Control App |
|---|---|---|
| Baseline | 24.29 ± 3.07 | 24.36 ± 2.53 |
| 6 Months | 24.72 ± 1.43 | 24.70 ± 1.25 |
| 12 Month | 24.70 ± 1.81 | 24.38 ± 2.49 |
Digit-Symbol Substitution Test (DSST), utilizing the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding subtest. It is a paper-based assessment used to evaluate processing speed, visual-motor coordination, and sustained attention. Participants are provided a key pairing numbers (1 through 9) with simple geometric symbols. They are given a strict time limit (120 seconds) to draw the correct corresponding symbols beneath a series of randomized numbers. The final score is the total number of correctly drawn symbols within the time limit. The score ranges from a minimum of 0 to a maximum of 135 (the maximum possible items on the WAIS-IV Coding form). Higher values represent a greater number of correctly matched symbols, indicating faster processing speed and better cognitive performance (a better outcome). Lower scores indicate slower processing speed (a worse outcome).
| Score on a Scale | Brain Safe App | Attention Control App |
|---|---|---|
| Baseline | 41.37 ± 12.42 | 41.31 ± 12.04 |
| 6 Months | 42.17 ± 12.41 | 42.48 ± 13.98 |
| 12 Month | 43.43 ± 11.25 | 43.63 ± 13.61 |
Collected over From enrollement to completion of 12 month followup. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Brain Safe App | 3/342 (0.9%) | 96/342 (28.1%) | 13/342 (3.8%) |
| Attention Control App | 7/343 (2%) | 103/343 (30%) | 16/343 (4.7%) |
| Event | Brain Safe App | Attention Control App |
|---|---|---|
| HospitalizationGeneral disorders | 71/342 | 76/343 |
| Other/Unspecified Serious AEGeneral disorders | 27/342 | 22/343 |
| Disability/IncapacityGeneral disorders | 12/342 | 19/343 |
| Life ThreateningGeneral disorders | 1/342 | 2/343 |
| Event | Brain Safe App | Attention Control App |
|---|---|---|
| Non-serious AE - ModerateGeneral disorders | 6/342 | 10/343 |
| Non-serious AE - SevereGeneral disorders | 3/342 | 2/343 |
| Non-serious AE - Severity not recordedGeneral disorders | 3/342 | 3/343 |
| Non-serious AE - MildGeneral disorders | 1/342 | 1/343 |
Numbers align with Participant Flow
| Age, Continuous(Years) | Brain Safe App | Attention Control App | Total |
|---|---|---|---|
| Mean | 69.63 ± 6.73 | 69.06 ± 6.19 | 69.35 ± 6.47 |
| Sex: Female, Male(Participants) | Brain Safe App | Attention Control App | Total |
|---|---|---|---|
| Female | 262 | 259 | 521 |
| Male | 78 | 81 | 159 |
| Race (NIH/OMB)(Participants) | Brain Safe App | Attention Control App | Total |
|---|---|---|---|
| American Indian or Alaska Native | 5 | 7 | 12 |
| Asian | 2 | 1 | 3 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 37 | 36 | 73 |
| White | 288 | 290 | 578 |
| More than one race | 7 | 5 | 12 |
| Unknown or Not Reported | 3 | 3 | 6 |
| Ethnicity (NIH/OMB)(Participants) | Brain Safe App | Attention Control App | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 4 | 14 |
| Not Hispanic or Latino | 330 | 336 | 666 |
| Unknown or Not Reported | 2 | 3 | 5 |
| Highest Level of Education(Participants) | Brain Safe App | Attention Control App | Total |
|---|---|---|---|
| Grade/Middle/Some High School | 10 | 8 | 18 |
| High School Graduate or GED | 48 | 67 | 115 |
| Some College | 76 | 82 | 158 |
| College Degree | 118 | 97 | 215 |
| Masters or other advanced degree | 81 | 73 | 154 |
| Trade School | 7 | 13 | 20 |
| Missing/Not reported | 2 | 3 | 5 |
| Employment(Participants) | Brain Safe App | Attention Control App | Total |
|---|---|---|---|
| Yes, Full Time | 58 | 48 | 106 |
| Yes, Part Time | 40 | 35 | 75 |
| No | 242 | 257 | 499 |
| Missing | 2 | 3 | 5 |
| Medication Assistance(Participants) | Brain Safe App | Attention Control App | Total |
|---|---|---|---|
| No, I do it myself | 320 | 310 | 630 |
| Yes, from a healthcare professional | 4 | 5 | 9 |
| Yes, from a friend or family member | 16 | 25 | 41 |
| Missing | 2 | 3 | 5 |
| Charlson Comorbidity Index (CCI):(Scores on a Scale) | Brain Safe App | Attention Control App | Total |
|---|---|---|---|
| Mean | 1.09 ± 1.83 | 1.23 ± 1.92 | 1.16 ± 1.88 |
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