Enhancing Cognitive Control Abilities Using Mobile Technology in a Senior Living Community
Phase: NA
Conditions: Aging, Cognitive Change
Sponsor: University of California, San Francisco

ID: R21AG058896    
Enhancing Cognitive Control Abilities Using Mobile Technology in a Senior Living Community   
NCT04905849 
Statistical Design and Sample Size Calculation  
 
 
 
 
 
1/1/2018 
Participants. 120 older individuals using the aforementioned applications at the Brookline Senior Living 
communities, the largest owner and operator of senior living communities across the United States (1000+ 
communities, 100,000+ residents) where the average age of residents are 85 years old. With respect to study 
interest across each community, we have reached out to the resident directors at each non-demented community 
to gauge interest in this program: 84% of the resident directors believed at least some of their constituents would 
be interested in participating, with 73% of these respondents estimating between 1-10 individuals per site. Given 
that this is a feasibility study assessing: i) working with this seldomly studied population, ii) the implementation 
of mobile technology in a senior living community, and iii) the utility of a cognitive assessment that prescribes a 
personalized intervention regimen, an initial foray into this population with such an approach is well positioned 
for this particular R21 mechanism.  
Markers of success. The primary aim of this pilot study is to gather information about the feasibility of 
utilizing this type of assessment/intervention combination in a senior living community to set up a future R01 
application. To that end, our markers to assess feasibility will include: 1) how participating individuals and 
resident directors accept participating in this project, as assessed through exit surveys with each group, 2) how 
many eligible participants enrolled/participated/dropped out of this study, 3) what was the quality of the collected 
data (was there excessive missing/unusable data?), and 4) limited-efficacy testing to examine the expected 
degree of responsiveness to the two versions of the intervention.  
Sample size. A power analysis to determine the needed sample size for this study resulted in us having to 
recruit a minimum of N=120 (40 in each condition) to achieve a balanced factorial design, which should be quite 
attainable given the interest indicated by the resident directors. Assuming 25% attrition, our recruitment plan will 
yield 90 participants, which will allow us to assess changes in performance as a function of training. Given the 
number of primary comparisons (3 scores of cognitive control at 2 time points (Pre- and Post-training)), there 
would be 95% power to reveal a group X session interaction on any given outcome, even with only 90 total 
participants split across the 3 groups. This corresponds to a medium effect size of .53, which is reasonable for 
a feasibility study of this size given the study-associated logistics. Pre- and post-training outcome data will be 
modeled using mixed within- and between-subjects GLMs and multivariate regressions109. Significant 
interactions will be interrogated with appropriate follow-up tests between each group, including the direct 
assessment of effect size comparisons calculated using Satterthwaite's approximation110.  
Approach 
The goal of this R21 is to test the feasibility of deploying a targeted digital health remediation program 
for older adults in senior living communities based upon an initial characterization of these abilities. 
Below we discuss the logistics towards realizing this goal. 

Mixed Model Approach. Here we propose to use a sequential exploratory mixed method design115-119 for 
this pilot study. Specifically, a quantitative design will be used to: (1) collect descriptive information regarding 
older adults’ perceptions of each app to enhance the UX experience for this particular population to explore the 
feasibility of self-administration for cognitive assessment and remediation, and (2) make pre-, post-, within- and 
across-group comparisons of cognitive functioning based on neurocognitive test performance and self-rated 
assessments. The qualitative approach will begin with local semi-structured interviews regarding the use of each 
app, first in a group of 10 one-on-one sessions with seniors led by our UX testing consultant (see Letter of 
Support), followed by subsequent interrogation by senior-centric UX group testing group (Longevity Explorers™, 
see Letter of Support) whose members are seniors trained in UX design refinement. Using data gathered from 
these experiences, we will augment the UX design of each app for subsequent dissemination to the Brookdale 
Senior Centers for use. Brookdale participants will be asked questions about their experience following training, 
with feasibility of program participation assessed quantitatively by measuring the 
number and percentage of sessions completed per participant. Questions at this time 
point (previously used by Hill and colleagues90) will include “Do you feel your 
everyday thinking abilities have changed from doing the computer exercises and, if 
so, how? 2. What did you like about doing the computer exercises? 3. What did you 
dislike about doing the computer exercises? 4. Now that the study is over, would you 
keep doing the computer exercises?” Responses during said interviews will be 
transcribed, with frequency tallies of response consistencies per question across 
participants being tabulated. We will perform thematic analyses for the identification 
of important patterns/themes90, creating a coding framework that maximizes 
coherence amongst categories emerging from the qualitative data120-122. 
Protocol. Following the initial local UX testing, a convenience sample of 120 
older adults will be recruited from throughout the Brookdale Senior Centers 
throughout the United States (see Figure 3; see Recruitment and Retention Plan 
for additional participant enrollment details). These individuals will be asked to 
complete the battery of tasks on the ACE platform (~45min) to characterize cognitive 
control abilities before and after the assigned intervention. Following their initial 
assessment, each participant will be randomly assigned (using a pseudo-
randomized blocked design using blocks of 9 to ensure equivalent representation 
across groups) to a one of three intervention types: directed training (DT) on the 
ACCT platform, non-directed training (nDT) on the ACCT platform, or an expectancy-
matched placebo control platform (PC). We will ask each resident director and their 
residents to refrain from discussing their assigned intervention with other 
communities to preserve blinding across sites. The total training experience will 
encompass 6 weeks of training (3 days/week), with each training session lasting 36 
minutes (not including self-paced breaks). Each participant in the DT and nDT 
groups will engage in 12 3-minute blocks of submodules in each training session on 
the ACCT platform. However, those in the nDT group will play each of the three 
submodules 4 times equally, while participants in in the DT group will play 12 blocks 
proportionally weighted towards the cognitive control domain(s) that are most deficient at baseline as determined 
by their baseline ACE performance, and thus most likely to benefit from directed training. For example, if 
(following the ACE assessment) a given individual shows deficiencies on their attention and working memory 
scores but normal performance in their goal-management abilities, they will be prescribed 5 training runs of the 
attention & working memory modules and only 2 of the goal management module. Customization of each DT 
participant regime will be accomplished via a web portal at UCSF that transmits personalized training parameters 
directly to the individual’s ACCT application. Each training program contains self-guided instructional videos and 
practice modules for each treatment, consisting of 6 weeks of training (3 days per week). Training sessions are 
linked, such that the next session begins at the level attained at the end of the previous session. Participants are 
provided two types of feedback: 1) real-time feedback – indicating whether the participant successfully detected 
or classified the target and 2) punctuated feedback – participants advance through a series of “levels” that are 
reported at the beginning and end of each run. We will provide weekly feedback about intervention use and 
performance improvement (in addition to daily in-app feedback), in support of it utility found in a recent survey123: 
79% of health app users indicated that periodic feedback about their app usage encouraged them to continue.  

Expectancy-Matched Placebo Control. The placebo control group (PC) will engage in a battery of three apps 
delivered in the same prescribed manner as the other two groups, which we hypothesize as based on our 
experience will have minimal positive impact on the cognitive abilities we are assessing: i) an app with 100 
different logic games of varying difficulty and length, ii) a language-learning app with 10 language options, and 
iii) an app that offers a guided Tai Chi program. The total training experience here will also be for 6 weeks (3 
days/week), with each training session lasting ~30 minutes where participants will be asked to use each of the 
submodules for 10 minutes (not including self-paced breaks). We have already determined that this approach 
generates matched expectancy of benefits compared to our training groups by questioning 100 naïve individuals 
to predict their expected improvement on each cognitive domain after training on these apps (see 124 for details 
of expectancy testing). This revealed that placebo training generates equivalent expectations of improvement 
across each outcome measure as the DT group, thus serving as an effective placebo condition. Furthermore, 
initial pilot work examining transfer effects following training on this battery has shown no evidence of improved 
cognitive control with respect to attention or working memory abilities, supporting its utility as a placebo control.  
Assessments. All OAs will complete assessments at two periods: baseline and immediately following the 
intervention. In addition to measuring transfer to benefits to cognitive control (using ACE), we will also assess 
transfer of gains to functionally-relevant outcome measures, notably the Everyday Cognition Scale (ECog) to 
assess their ability to perform everyday tasks that demand memory, language, visuospatial abilities, planning, 
organization, and divided attention125,126. The ECog scale has been used in other cognitive interventions trials 
and proven to be sensitive enough to detect improvements in healthy OAs and differentiate OAs from mild 
MCI127,128. This survey will be sent directly to participants via an automated email campaign from Qualtrics™, 
with help from local resident mentors to complete these surveys on the same devices. Other surveys sent through 
this mechanism will include: i) a customized survey assessing participant expectancy across groups to further 
explore possible uncontrolled placebo effects (see for a description of this approach), ii) distractibility (via the 
Cognitive Failures Questionnaire)129, and general health and well-being (SF-36)130. 
Infrastructure Support. Brookdale has already established an elegant infrastructure for sending, tracking, 
and gathering information as needed across all of their communities. Brookdale has 100,000+ residents in 47 
states, divided into 5 geographic divisions, with several communications channels that provide resources on a 
monthly basis for Resident Programs associates. Each geographic division is led by a Directors of Resident 
Programs Engagement who supports the Resident Programs Associates in approximately 200+ communities. 
Each division is divided into approximately 50 areas, with each area supported by a Resident Programs “mentor”, 
and this team of 50+ mentors directly interacts with 15-20 communities. Resident directors have agreed to assist 
community residents in downloading and providing in-person help for this study, with Dr. Anguera running a 
distributed webinar for all resident directors to teach them about these tools prior to study launch. Telephone 
and email support by the study team will be provided throughout the training period, in addition to active onsite 
support via resident directors. Each app will be configured to wirelessly transmit data automatically to our secure 
HIPPA-compliant server at UCSF when each training session is completed, with a custom web-portal facilitating 
data tracking in real-time to monitor participant adherence and data quality.  
 Markers of success. The primary aim of this pilot study is to gather information about the feasibility of 
utilizing this type of assessment/intervention combination in a senior living community to set up a future R01 
application. To that end, our markers to assess feasibility will include: 1) how participating individuals and 
resident directors accept participating in this project, as assessed through exit surveys with each group, 2) how 
many eligible participants enrolled/participated/dropped out of this study, 3) what was the quality of the collected 
data (was there excessive missing/unusable data?), and 4) limited-efficacy testing to examine the expected 
degree of responsiveness to the two versions of the intervention.