Development of a Comprehensive, Active Seating System to Lessen Sedentariness and Improve Health and Wellness in Older Adults: In-home Testing Phase
Phase: NA
Conditions: Healthy Lifestyle
Sponsor: University of Southern California

 
 
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FitSitt Phase I SBIR Protocol 
 
*Black highlighted text within the body of each section contains confidential, proprietary information belonging 
to Activ Sitting, Inc. This cannot be shared publicly and thus is redacted.  
 
STUDY TITLE:  
Toward development of a comprehensive, in-home, active seating system to lessen sedentariness and improve 
health and wellness in older adults. 
 
MULTIPLE PI NAMES: 
• 
Stacey L. Schepens Niemiec, PhD, OTR/L, DipACLM (USC) 
• 
Roger Leib, AIA, ACHA (Activ Sitting, Inc.) 
 
STUDY PROCEDURES 
1. Background/Rationale  
Older adults spend 80% of their day sitting (Matthews et al., 2008; Stamatakis et al., 2012). Given the 
strong link between inactivity and lifestyle-related diseases (Biswas et al., 2015), the economic burden 
of sedentariness is high: $117 billion of annual United States healthcare costs can be attributed to 
inactivity (Carlson et al., 2015). There is growing interest in bolstering older adults’ activity patterns by 
decreasing prolonged sedentary activity (Gennuso et al., 2013; Martin et al., 2015). Whereas the 
evidence base addressing theory of and methods for improving physical activity is vast, much less is 
known about how to intervene on patterns of sedentariness. Important to consider are the wide-ranging 
barriers older adults encounter to reducing immobile time such as lack of convenient options (Beck et 
al., 2016; Mathews et al., 2010; Witcher et al., 2007), limited self-awareness about one’s own activity 
patterns (van Uffelen et al., 2011), low motivation (Baert et al., 2015; Bethancourt et al., 2014), and fear 
of being injured (Baert et al., 2015; Rasinaho et al., 2007). 
 
Targeting activity patterns even in late life is a viable option to slow progression from health to 
disability (Berk et al., 2006; Buchman et al., 2012; Sun et al., 2010), and engaging in even light physical 
activity can beneficially affect psychosocial health, glucose metabolism, lipid status, and mortality 
(Bertheussen et al., 2011; Fuezeki et al., 2017; Kim et al., 2012). An innovative way to tackle inactivity 
consists of altering older adults’ “sedentary space” in which they spend their time (Chastin et al., 2015). 
The Activ Sitting-USC team proposes to develop a seat-based wellness furnishing—FitSitt—designed to 
meet older people’s healthy lifestyle needs. This functional solution blends features of a posture chair, 
exercise machine, and health tracking system. It can be easily integrated into older adults’ living spaces 
and everyday routines, maximizing potential for long-term adoption and use. A safe and practical 
activity-promoting solution for older adults to access in-home, like FitSitt, is needed now more than ever 
in the wake of COVID-19, especially given the pandemic’s consequences on people’s capacity to lead 
an active lifestyle (Woods et al., 2020). 
 
2. Purpose/Objectives/Aims/Research Questions  
This study had two primary specific aims and associated milestones: 
1) 
Build an enhanced FitSitt system prototype that includes specialty features and is suitable for user 
testing.  
• Milestone 1: develop a specifications report for new FitSitt features.  
• Milestone 2: build one operational FitSitt system compliant with Milestone 1 specifications.  
• Milestone 3: produce the first version (v1) of a Failure Modes Effects and Criticality Analysis 
(FMECA) report.  

 
 
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• Milestone 4: take corrective actions by reducing critical indices of failure modes to “acceptable” 
or “consideration” levels or removing them from the system. 
2) 
Assess the initial feasibility, acceptability, and safety of the enhanced FitSitt system with target 
users.  
• Milestone 1: collate and categorize available mixed-methods data as process, functionality, 
hardware, or software information for analysis in a second FMECA cycle.  
• Milestone 2: produce a v2 FMECA report that details the necessary corrective actions, and who 
will take them, to move failure modes into acceptable criticality levels. 
The protocol included for clinicaltrials.gov reporting here only contains information relevant to the in-
home testing phase of the overall study given this is the only phase that involves a clinical trial. 
 
3. Participants  
3.a. Inclusion and exclusion criteria 
 
 
In-home Testing Stage 
Inclusion criteria  
(1) Age 65 years old or older 
Justification: the target consumer group for FitSitt is older adults. 
(2) English-speaking 
Justification: we will not have personnel available for language translation. 
(3) Live in local Los Angeles area and no plans to vacation away from home during the trial period  
Justification: research staff will not have the resources to travel outside of the local LA 
community. Vacation away from home would artificially reduce time spent using the FitSitt 
during the brief trial period.  
(4) 
Self-reported ability to safely engage in 30 minutes of light-intensity activity per day 
Justification: this criterion is indicative of a person’s basic health status and ability to tolerate 
use of FitSitt without exacerbating health conditions. 
(5) 
Self-reported ability to pedal comfortably without stopping for 5 minutes 
Justification:  this criterion is indicative of a person’s basic health status, minimum physical 
capacity, and ability to tolerate use of the FitSitt’s treadles without exacerbating health 
conditions. 
(6) Community-dwelling  
Justification: FitSitt requires testing in a relatively healthy population first, despite there likely 
is future application for older adults who are institutionalized. 
Exclusion criteria 
(1) 
Dependence in transferring to a chair safely 
Justification: this criterion requires an individual to have a sufficient level of function to 
safely use the chair.  
(2) 
Inability to safely and reliably access and operate FitSitt (ascertained by a brief demonstration 
at beginning of in-home visit) 
Justification: this will help to ensure we will receive necessary data to study usage patterns 
and user satisfaction. 
(3) A member living in the same household participated in the in-home testing stage of this study 
Justification: the study requires diverse perspectives about the prototype to be tested in-home. 
A member of the same household having already tested the prototype may unduly influence 
the individual’s own perspective or may have very similar feedback to the other participant. 
(4) 
Participated in the in-lab testing stage of the study already 
 
 
Justification: this criterion helps to ensure we have a diverse pool of perspectives gathered 
from participants at each stage of the prototype testing.  

 
 
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(5) Unstable health conditions such as uncontrolled blood pressure, end-stage renal failure on 
renal replacement therapy, or malignancy currently on chemotherapy. 
Justification: this criterion is indicative a person’s basic health status and ability to tolerate use 
of FitSitt without exacerbating unstable conditions.  
 
3.b. Rationale for excluding children 
Children are excluded from this study because we are developing a seating system tailored 
specifically to older adults. The system itself is also designed for adult sized anthropometrics. 
 
 
3.c. Special subject population 
The study participants are not a part of a special subject population. Participants are generally 
healthy, community-living older people. 
 
4. Recruitment/Screening Process (sampling strategy)  
4.a. Recruitment Locations/Sources 
• USC Healthy Minds Research Volunteer Registry healthyminds.usc.edu   
• Collaborative Approach for Asian Americans & Pacific Islanders Research & Education (CARE) 
Registry 
• Word of mouth/personal solicitation 
• Flyering 
• Tables at community events/venues 
• Website (e.g., Keck Medicine of USC Clinical Trials website) and social media postings (e.g., 
Nextdoor) 
• Emails to participants in a previous study (HS-16-00670) that was led by PI Schepens Niemiec 
• Front Porch Center for Innovation and Wellbeing recruitment support 
 
4.b. Recruitment Methods 
We will use a multi-faceted recruitment approach for the proposed research. We will recruit 15 
participants for co-design workshops featured in Aim 1, as well as 30 + 15 participants for an in-lab and 
a three-day in-home testing period for Aim 2, respectively. We will aim to enroll participants in a way 
that is representative of LA County: ~32% (n=19) non-White, ~48% (n=29) Latino/Hispanic, and ~57% 
(n=34) female. We will also aim for representation from both age groups (roughly equal representation 
from either group) and by level of sedentariness (i.e., watch <2 hours of TV per day on average [~45% 
representation] vs. watch >2 hours of TV per day on average [~55% representation]). Recruitment will 
take place using the following sources and methods: 
 
USC Healthy Minds Research Volunteer Registry – potential participants will be identified 
through purposive sampling using the USC Healthy Minds Research Volunteer Registry 
healthyminds.usc.edu, which will serve as our primary recruitment source. Additional recruitment 
strategies and sources will be activated should this primary recruitment means fall short of our 
recruitment goals and timeline. The Healthy Minds registry houses the Healthy Minds Volunteer List of 
older adults who have previously expressed interest in research on aging. This list can be accessed by 
research groups who pay an annual subscription and proof of IRB approval.  
 
Once made available, the research team will export the volunteer list to Excel, and sort it by age 
group (65–84, 85+), sex (male, female), and race/ethnicity. Participants will be purposively selected and 
contacted from the stratified Healthy Minds Volunteer List to be screened and enrolled, should they 
meet necessary eligibility criteria, fulfill purposive sampling requirements, and have interest in 
participation. Imbalance of participants from any of the categories will be remedied by reaching out to 
only selected individuals who are from any of the underrepresented groups, and/or enrolling only a 

 
 
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fraction of individuals from an overrepresented group. Additional Healthy Minds recruitment script 
content (in phone-ready format) will be added to the standard recruitment script included in our 
screening form and as a part of an email script for Healthy Minds volunteers. The Healthy Minds 
registry also has a website for registrants on which brief descriptions of participating studies are 
included. 
 
Collaborative Approach for Asian Americans & Pacific Islanders Research & Education 
(CARE) Registry – this registry houses a list of volunteers who identify as Asian or Pacific Islander with 
an interest in health-related studies across the lifespan. The research team will submit an application to 
the CARE team that describes the study and eligibility criteria, and show proof of IRB approval. Should 
the CARE team approve the application, they will run queries of their registry with the study’s basic 
eligibility criteria like age and language spoken. A list of contacts who fit these criteria will be passed 
from the CARE team to the research team to recruit. Additional CARE Registry recruitment script 
content (in email-ready and phone-ready format) will be added to the standard recruitment script 
included in our screening form.  
 
Word of mouth/personal solicitation – we will engage in word of mouth/snowball sampling, a 
chain-referral method where participants will refer individuals to the study team who are not part of the 
same household (see in-lab and in-home testing exclusion criteria above). The study team will also 
spread the word about the study through their personal networks.  
 
Flyering – we will post flyers around the local community and attach them electronically to any 
word-of-mouth outreach communications that happen over time. If individuals see a flyer, they will have 
the team’s contact information to reach out to the study team. 
 
Tables at community events/venues – the study team will go out into the community to host 
information tables at various events or venues that attract older adults (e.g., senior community centers, 
senior living facilities, health fairs). Staff will be available to make a brief presentation about the study if 
requested by the venue, to answer questions about the study for interested individuals, and to hand out 
recruitment flyers.  
 
Websites/Social media outlets –We will utilize various websites for study recruitment. We will 
post an ad on the Keck Medicine of USC Clinical Trials website, which includes a listing of any clinical 
trial available at USC. Content to be posted on the site must first be approved by IRB. Once published, 
individuals can read about the study and provide their contact information on a fillable form on the site. 
A notification is sent to the study team with that person’s contact. We will also post a very brief 
summary of the study on the Chan Division website that will link to the Keck Medicine of USC Clinical 
Trials website for more information. Contact information will be made available for individuals to reach 
out to the study team. Finally, we will post advertisements of the study on social media apps like 
Facebook, Instagram, and Nextdoor. 
 
Front Porch Center for Innovation and Wellbeing (FPCIW) – we will engage our community 
partner, FPCIW, as needed if other recruitment methods are not sufficient. Grant funds have been 
allocated to offset FPCIW’s costs in the event we require their recruitment assistance. They would send 
flyers to their senior living communities and make announcements at their facility events. 
 
  
4.c. Recruitment Materials 
A number of materials will be used for recruitment including the following:  
Screening, contact, and referral form – [document “Screening Contact Referral Form FitSitt 
SBIR Ph1” in iStar 24.2] – this form will be used for all prospective participants regardless of how 
contact information was obtained. It includes a recruitment script—one appropriate for each stage of the 
study and selected based on enrollment needs—at the beginning to use for interested individuals who 
contact the study team about participation. The form also includes a consent to retain screening data as 
described in 4.d below. The form will be used to gather demographics, general health, and additional 
information to determine eligibility. Contact and referral information is stored securely on REDCap such 

 
 
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that personally identifying information linking participant to study ID is only seen by authorized 
research personnel—a setting in REDCap will be used to indicate protected information. 
Flyers – [documents “Flyer FitSitt  SBIR Ph1 [style of flyer labeled here in file name],” in iStar 
24.2] – various versions of a recruitment flyer will be used such as ones that have a “techy” style, ones 
with and without pull tabs, and ones geared toward a younger audience who could use word-of-mouth to 
inform older individuals.  
Website/social media advertisements – [documents “Keck Clin Trial Web Ad” and “Chan 
Website Recruit” in iStar 24.2] – these website advertisements will include a description of the study 
and a contact information individuals can use to reach the study team. For social media websites like 
Facebook, Instagram, and Nextdoor, we will utilize the approved content (images and text) from the 
submitted flyers above. 
Registry/database/study-specific recruitment – For individuals identified through the CARE 
Registry or the Healthy Minds Research Volunteer Registry, we will use a phone-ready recruitment 
script that is embedded within the general screening script [document “Screening Contact Referral Form 
FitSitt SBIR Ph1” in iStar 24.2]. See sections in the Introduction segment that refer specifically to 
CARE or Healthy Minds. Additionally, we will use an email-/postal mail-ready script to reach out to 
participants digitally or through US Mail [documents “CARE FitSitt Mail Recruit” and “Healthy Minds 
FitSitt Mail Recruit” in iStar 24.2]. The letter includes a description of the registry from which we 
obtained their contact, as well as a description of our study and necessary contact information. A brief 
study description [document “Healthy Minds Site Blurb” in iStar 24.2] will also be posted on the 
Healthy Minds registrant website. 
 
4.d. Screening Process 
If a potential participant responds to any of the aforementioned recruitment methods, they will be 
screened for eligibility using a study-specific questionnaire [document “Screening Contact Referral 
Form FitSitt SBIR Ph1” in iStar 24.2] via telephone or in person. MPI Schepens Niemiec will determine 
final eligibility in any case where suitability for the study is unclear. At the beginning of the screening 
process, the potential participant will be guided through a brief screening consent to request permission 
to retain screening data for future use. This screening consent includes a brief description of the study, 
what will be done with screening data if individuals are eligible/ineligible and if they are eligible those 
data will be linked to their main study data if they decide to participate. Should an individual decline to 
provide screening consent but would like to continue through screening, the study team will complete 
the screening but will make note the individual’s information cannot be retained for future use with the 
main study. Screening data will be entered into REDCap for storage. To reduce screening burden for 
prospective participants, we are requesting an Alteration of the Required Elements of Consent for the 
Screening Consent. The elements being waived are: 
• A description of any reasonably foreseeable risks or discomforts to the participant. 
• A description of any benefits to the participant or to others, which may be reasonably be 
expected from the research. 
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be 
advantageous to the participant. 
• A statement describing the extent, if any, to which confidentiality of records identifying the 
participant will be maintained. 
• An explanation of whom to contact for answers to pertinent questions about the research and 
research participants' rights, and whom to contact in the event of a research-related injury to the 
participant. 
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss 
of benefits to which the participant is otherwise entitled, and the subject may discontinue 

 
 
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participation at any time without penalty or loss of benefits to which the participant is otherwise 
entitled. (The consent says participation is voluntary, but the rest of the text is waived). 
  
5. Methods  
5.a. Detailed description of the project 
5.a.i. Step-by-step methods 
Recruitment, Screening, and Informed Consent Procedures 
Recruitment and screening procedures are detailed in section 4.b and 4.d of this document, 
respectively. Informed consent for the study will take place using the following procedures. If a 
person fully meets eligibility criteria as determined through screening and continues to express 
interest in enrollment following screening, an informed consent session will take place either 
immediately or will be scheduled for a future time, depending on the individual’s preference/ 
availability. The consent process will take place either remotely through digital consenting available 
from REDCap or in person. In all cases, informed consent will be obtained only by authorized, trained 
study personnel affiliated with USC and not by employees of Activ Sitting, Inc. to avoid conflict of 
interest. Each prospective participant will be given time to read the consent and discuss their options 
with project staff and family members. To ensure ample time to peruse the consent information, we 
routinely mail or e-mail copies of a sample informed consent document to each interested party. 
When the prospective participant is ready, a dialogue regarding the study will ensue. The study team 
member is responsible for guiding the discussion, and will be instructed to follow a standard format to 
ensure all required elements are introduced. Explanations will cover all aspects of participation 
requirements, participants’ rights, and other relevant information. Individuals will have an opportunity 
to ask questions about the study and, if they choose to enroll, will sign a consent form. They will be 
provided with a copy of the consent form. 
 
 
Study Procedures: General 
This study includes three stages: (1) Focus Group, (2) In-lab Testing, (3) In-home Testing. Study 
procedures for only the in-home testing phase are delineated below for purposes of clinicaltrials.gov. 
 
Study Procedures: In-home Testing Stage 
Overview. A separate set of users (N=15) who did not participate in the in-lab activities will complete 
an in-home trial of a FitSitt prototype. The trial period will last between 3 and 7 days (depending on 
availability of prototypes and scheduling) and will capture free-living feasibility, acceptability, and 
potential health-relevant short-term benefits of the system. Participation will require two in-person 
contacts within approximately a 2-week period, which will include pre-session activities, an in-home 
orientation to FitSitt, and a follow-up visit in-home.  
Pre-session activities. Participants will be mailed an activPAL and/or ActiGraph activity monitor 
package (including instructions and supplies) to don 3 days in advance of their initial in-home session. 
They will continue to wear these monitors for the duration of the chair trial period. This wear 
schedule will capture objective physical activity patterns prior to FitSitt availability, as well as 
activity patterns when the system is present in their home. Participants will also be sent electronic 
questionnaires (or hard copy if requested) to complete prior to their appointment. The battery of 
questionnaires (see Table 3) to be used at baseline include the same forms utilized in the in-lab 
session as well as an additional activity monitoring log [document “Activity Monitor Instructions 
Log” in iStar 21.2]. Any questionnaires left incomplete will be completed at the beginning of the in-
home session.  
In-home orientation. Participants will be provided with an in-home orientation to FitSitt. This 
session will be led by research personnel unaffiliated with Activ Sitting, Inc. Representatives of Activ 
Sitting, Inc. authorized to interact with participants may be present to help with device set-up and 

 
 
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installation as needed. The session will last approximately 2 hours. Personnel will use a checklist and 
data collection sheet to guide the visit and document necessary information [document “Tester 
Checklist Collect Home bsl” in iStar 21.2]. Included in this data collection form are a few open-ended 
questions as a mini-interview at baseline. This interview segment will be audio-recorded. The visit 
will generally address the following: 
Daily activity engagement and environment: To aid in system placement, the research assistant 
will question users about their common daily activities and where they spend the most time sitting. 
(Responses will be documented.) Staff will recommend positioning the chair near this location, 
although users will make the final decision. The assistant will conduct a brief environmental scan to 
ensure the final location is safe and practical for the chair to be arranged. Final location details will be 
documented. 
Hardware/software fitting: The research assistant will work with the participant to adjust the 
anthropometric settings (e.g., distance of treadles, seat depth). The assistant will also explain the use 
of the resistance settings so that users can choose the level of resistance best suited to them. For this 
study, resistance settings that allow only light physical activity will be demonstrated and 
recommended. Software setting options (e.g., frequency of cues to move) will be reviewed and set. 
System features orientation, education, and interview: Users will be provided with an orientation 
to the FitSitt system prototype. The assistant will begin the conversation by engaging the participant 
in an evidence-informed dialogue about the effects of sedentary activity on health (e.g., 
cardiometabolic function) and daily life (e.g., sleep quality) and the benefits of disrupting prolonged 
immobile time across the day (Hwang et al., 2021; Saunders et al., 2020).  
Participants’ attention will then be directed to FitSitt. A discussion about how this seating system 
can act as a means of combatting long periods of inactivity will be had, linking it to the education on 
sedentary behavior. All available features of the seating system, their purpose, how to use them, and 
their potential benefits will be discussed and demonstrated. For instance, users will be shown the 
ergonomic design of the chair and how keeping one’s feet on the treadles allows for maintenance of a 
non-slouched posture and expansion of the ribcage to support deeper breathing. The assistant will 
explain the purpose of the treadles, which are designed to allow for gentle mobilization (at light 
resistance settings), blood flow in the lower extremities, and leg strengthening (when higher 
resistance settings are activated). If a digital user interface displaying information is made available, 
participants will be oriented to that accessory and how to navigate it. Other features and 
functionalities such as a tabletop surface, rocking mechanism, and synchro-tilt recline will also be 
introduced, as they are available for the provided prototype. Individuals will also partake in a 
discussion of how the chair can be used during engagement in their personally relevant and 
meaningful activities (e.g., working on the computer, watching TV) with minimal disruption. Such 
activities may be practiced at that time. This is an important element of the educational session as the 
users should not feel discouraged from doing their traditionally sedentary activities that may have 
health and quality of life benefits (e.g., cognitive stimulation through reading and doing puzzles) 
(Copeland, 2019). Participants will be given a summary sheet of key discussion points [document 
“Sedentary Edu FitSitt Summary” in iStar 21.2).  
Use expectations: The assistant will explain expectations for use of the chair during the study 
period. FitSitt will be presented as a tool useful for breaking up sitting without impeding desired 
activities—focus is not on its exerciser function but rather its capacity to reduce sedentary activity. 
Because we hypothesize that benefits will accrue at even low resistance settings, the assistant will 
encourage individuals to use the chair for brief, light activity with low resistance (as preset during 
fitting). The resistance setting follows empirical evidence supporting replacement of sedentary 
activity with light physical activity (Buman et al., 2010). Two types of evidence-based 
recommendations for treadle use will be offered to the user for which they can choose their most 
preferred: (1) when occupying the chair, pedal at their leisure across the day, with a goal of 

 
 
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interrupting 30-minute sitting periods with microbursts (1–3 minutes) of treadle use. Although no 
unified guidelines exist yet for reducing sedentary activity (Ryan et al., 2011), this dose is based on 
recommendations for persons with low-back pain (Atlas & Deyo, 2001) and is linked to reduced 
fatigue (Bergouignan et al., 2016), increased energy (Bergouignan et al., 2016), improved mood 
(Wennberg et al., 2016), and good metabolic health (Owen et al., 2010); or (2) pedal at their leisure 
across the day, with a goal of interrupting each hour of sitting with at least 5 minutes total of light 
movement. This second break length was informed by a Bond’s study whereby disrupting each hour 
with a six-minute break was preferred over 3-minute breaks every 30 minutes and 12-minute breaks 
every 120 minutes in adults with overweight/obesity (Bond et al., 2014). Participants will also be 
encouraged to use the system as their primary seat, especially in instances where extended sitting is 
common such as while one works at a table/desk or during TV viewing. The assistant will further 
explain that although the more one accesses the treadle portion, the greater the energy expenditure, 
there is no expectation for continued use throughout the day; rather one should use the device at 
leisure and when comfortable and convenient to break up sedentary time. Participants will also be 
instructed to avoid using the treadles for more than one hour in total throughout the day to minimize 
any acute soreness potentially felt secondary to increased activity. Other features that promote 
movement such as the synchro-tilt recline to stretch the body and/or the rocking condition to engage 
core muscles will also be encouraged to use. 
Safety considerations and device care: The research assistant will discuss safety considerations. 
Participants will be shown how to enter and exit the chair safely. If used in free-standing applications 
(e.g., TV watching in the living room) where the foot extension and/or tray may be in the line of 
travel, as opposed to stowed in front of a desk/table, the research assistant will educate the user about 
safe maneuvering around the system. Research staff will also discuss safety concerning any power 
cords attached to the system and secure cords (if necessary) in a safe manner (e.g., taping to floor). 
The prototype currently has a design for breakaway magnetic cords such that if the system is plugged 
in at that time and a cord is tripped on, the cord releases the magnet to reduce the tripping hazard. 
Device care, such as avoidance of having liquids placed/used near the electronic components of the 
system will be discussed. 
Activity and sensor monitoring: Users will be asked to continue wearing the activity monitors 
they had donned prior to the home session throughout the duration of the FitSitt trial period. They will 
be given additional supplies in the event either monitor falls off prior to completion of the prototype 
trial period. Users will be provided with an activity monitor log [document “Activity Monitor 
Instructions Log” in iStar 21.2] to keep track of wear periods. Users will also be informed that the 
FitSitt has embedded sensors that track system usage (e.g., treadle movements, seat occupancy) in real 
time and may provide reminders (e.g., vibration from the seat surface) if the user has sat for too long 
based on a movement goal set during fitting. At this time, they will also be given the Biostrap EVO to 
wear on either wrist for the entirety of the in-home trial period. This monitor will not be provided in 
advance like in the case of the activPAL and ActiGraph activity monitors. Therefore, the wear period 
will only be up to 7 days instead of 10 days as with the activPAL/ActiGraph. Participants will be 
instructed to avoid baths, swimming, and saunas to protect all activity monitors.  
 
Follow-up activities and equipment removal. After trialing the chair for 3 to 7 days, a follow-up 
visit will take place, which can occur in-person, virtually, or in hybrid format. (FitSitt equipment 
retrieval must be in person.) Self-report questionnaires (see Table 3) will be emailed in advance of the 
visit for completion. An audio-recorded semi-structured interview (see section 5.b.ii) to discuss the 
users’ experiences during the study will be completed either virtually or in-person [document 
“Follow-up In-home Interview Guide” in iStar 21.2]. Research or Activ Sitting, Inc. staff will arrange 
to remove the chair and collect any other equipment (e.g., activity monitor) upon completion of 
follow-up activities. 
 

 
 
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Compensation  
Participants will be compensated for their time to complete individual activities for the various stages 
of studies. Payment will be given by check mailed at the end of study participation and will be 
prorated based on activities they complete. The payment schedule for the in-home stage is delineated 
below in Table 2. 
 
Table 2: Schedule of compensation/costs for each study stage 
In-home Testing Stage (up to $165 total at end of study) 
• $10 complete questionnaires at the beginning of the study 
• $20 wear an activity and health monitor for up to 10 days 
• $40 complete a 2-hour in-home orientation to FitSitt 
• $50 utilize a FitSitt prototype in home for 3 to 7 days 
• $10 complete questionnaires at the end of the study 
• $20 complete a follow-up interview 
• $15 return the loaned activity and health monitors 
 
5.a.ii. Intervention details: FitSitt system 
The FitSitt is a specialized wellness seating system [document “FitSitt Brochure” in iStar 40.1] to 
reduce and reverse negative outcomes of inactivity in older adults. The core chair provides seat-based 
stepping movement, full-body postural support that responds to and facilitates stepping actions, and 
reclining capabilities to allow stretching/postural changes, all of which are intended to be seamlessly 
integrated into individuals’ daily routines and living spaces. The system will be enhanced using 
stakeholder feedback along the stages of development, adding specialized older adult-custom features 
that are tailored to older adults’ expressed needs. To-date, no other fitness platform tailored to older 
consumers has been systematically developed and optimized to address sedentary activity in the aging 
population. 
FitSitt reimagines the possibilities in sitting by reengineering sitting. First, we turn sitting from a 
sedentary into a more active condition through introduction of FitSitt, thereby altering the living 
space in which people commonly sit (Figure 1). This requires reinfusing activity into daily sitting 
routines in a convenient, unobtrusive, and non-disruptive 
way. FitSitt development is underway to integrate braking 
casters that will make it easily moveable from room to 
room and between activities. Next, we accommodate 
sitting to the wide range of exercise needs and physical 
capacities of older adults. One way we do this is by using 
sitting to induce and sustain healthy rather than slumped 
postures that characterize the seated positioning of many 
older people (Kuo et al., 2009). Finally, internet-
connected sensors will track and combine FitSitt usage 
and physical activity behaviors. Some key design and technical details are included below.  
Figure 1. In-home Use of FitSitt for Free-
standing or At-table Tasks. 
Redacted 

 
 
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Postural support. In standard chairs, occupants are usually positioned with hips slid anteriorly, 
with shoulders slumped forwards, or at the front edge of the seat, which fosters hunched sitting 
(Figure 2A). Such postures are associated with everything from neck pain, back problems, and joint 
degeneration, to heartburn, slowed digestion, and mood 
disorders (Harvard Medical School, 2018; Swann, 2009). In 
contrast, FitSitt helps keep the user in healthy postures—
whether sitting upright or reclined, providing postural 
support that is beneficial to all, but especially for those with 
poor postural control or degenerative spinal changes such 
as thoracic kyphosis prevalent in older adults. This is 
accomplished in part by a low, retractable feature in front 
of the seat support that allows the user to push against it 
with their legs, helping to retain the pelvis at the rear of 
the seat and in combination with an articulated backrest, tipping the pelvis forwardly (Figure 2B).  
Active exerciser. Next, we used this front-of-seat feature to provide exercise by designing it as 
reciprocating foot treadles. We engineered it for a pushing vs. cyclical motion both to help retain the 
pelvis at the rear of the seat and also to keep the knees low enough to be used under a standard-height 
table/desk or other work surface low enough to maintain good ergonomics during any task for which 
a support surface is needed, from knitting to internet surfing (Figure 1). Such motions are easy to 
assimilate and do not require training—two considerations which increase physical activity 
engagement in older populations. The resistance of these treadles is user-adjustable by turning an 
easily reached dial to any of nine (intensity) settings.  
Synchronized movement and support. Next, we split, longitudinally, the front half of the seat, 
hinged them off the rear half of the seat, causing them to reciprocate too (one is up while the other is 
down; Figure 3). This was done to fully support the under-thighs (thus lessening, by distributing, 
overall skin loads) while also accommodating their motion as the user 
pedals. FitSitt near-eliminates under-thigh pressure with its 
reciprocating seat flaps, allowing unobstructed movement and proper 
blood flow.  
To operate the hardware, the user’s moving body drives support 
surface movement. Pushing one pedal forwardly lowers one thigh 
causing the opposite seat front to lift the other thigh. Users may recline 
through ~40º (Figure 3), which facilitates postural change without 
having to stand. As the user alternates pressure between treadles, 
lumbopelvic mobility increases, diffusing oxygen and glucose into 
intervertebral discs while releasing stored muscular lactic acid, which 
is beneficial to reduce stiffness and annular load (Grunhagen et al., 
2006). A center-pivoting lumbar support provides continuous lower-
back support during this motion. Meanwhile, the upper-back support 
remains static so there is no induced motion to the upper body, 
shoulders, and arms that would compromise any task performance, from eating to typing.  
FitSitt Supports Behavior Change:  
FitSitt will include a seat-pressure-based sensor that speaks to vibratory sensors and/or a digital 
interface in real-time to optionally alert users during "passive chair use." Context-aware prompting to 
remind users to engage in physical activity is an effective intervention for older adults that facilitates 
long-term physical activity behavior change (Chase, 2013). Intervening on sedentary activity at both 
the right time (e.g., when users have been sedentary for an extended period) and place (i.e., when 
users are occupying FitSitt and equipped with a tool to be responsive to the cue) is possible through 
Figure 2.  Juxtaposition of Typical 
Sitting Postures and Posture Supported 
A 
B
Figure 3. Flapping Seat 
Fronts and Full-body Stretch 
with No-tip 40º Extended 
Recline. 
Redacted 

 
 
11 
 
Revised 06/15/2023 
the FitSitt solution. Basic usage information (e.g., time spent occupying 
the chair without moving, “steps” pedaled) recorded in brief epochs from 
sensor data will be relayed, will be collated in a cloud-based spreadsheet, 
and will be displayed back to the user through a low-fidelity user interface 
as feasible with the available prototype. Figure 4 demonstrates a 
possible design of the user interface attached to the system using a 
tablet on a moveable arm.  
Importantly, FitSitt is classified as a general wellness device as 
opposed to a medical device regulated by the FDA, “offering general improvement to functions 
associated with a general state of health that do not make any reference to diseases or conditions." 
See the characteristics of a low-risk wellness device as noted in General Wellness: Policy for Low 
Risk Devices put forth by the FDA [document “General Wellness Device Regulations” in iStar 40.1]. 
 
5.a.iii. Participant suicidality information 
Not applicable: information about self-harm or suicidality will not be collected as part of this study. 
 
5.a.iv. Protect participant privacy and confidentiality 
Confidentiality and participants’ privacy will be maintained to the extent possible at each stage of the 
study. With respect to study personnel who will interact with participants, we will maintain strict 
standards that forbid the leakage of information about study participants to unauthorized individuals 
either within or outside the study team. Focus group and in-lab activities will be conducted in private 
spaces (if in person) that will be reserved for participants and research personnel. Although the in-
home setting cannot be controlled by research personnel, we will ask participants to provide as private 
as possible of a space during the study activities. Audio and video recordings made during any stage 
of the study will be labeled based on participant ID as opposed to personally identifying information. 
Recorded content will be transcribed by authorized personnel. If personally identifying information 
was recorded during the session (aside from a person’s likeness from video recordings), transcription 
files will be edited, redacting personal information from the file or replaced with a participant ID. 
Audio/video recordings will be listened to in a private setting and will be stored on a secure server 
available through USC until the transcription process and qualitative data analyses are complete. IDs 
and real names will only be connected through the REDCap secure data management system. 
Although audio-video recording will be required for participation in the various stages of the study, a 
media release form that specifies uses of such audio/video data beyond research purposes will be 
provided to participants for them to opt in or out of each use [document “Media Release Form” in 
iStar 40.1]. Combined, these strategies are likely to succeed in eliminating any possible harm to 
participants due to leaking of personal information. 
 
5.a.v. Data management, storage, and monitoring plans 
MPI Schepens Niemiec will oversee general data management and analytic functions with guidance 
from the USC team’s statistician. Schepens Niemiec’s team will collaborate with authorized Activ 
Sitting, Inc. and Senseer Health Inc. personnel regarding data management of sensor-captured data 
from FitSitt or any wearables linked to the system. Activ Sitting and Senseer Health Inc. will store, 
clean, and transfer raw usage data obtained from FitSitt sensors through secure cloud-based services 
(Linode Cloud Computing Platform [allowing HIPAA compliant storage and transfer] and SharePoint 
[protected through USC]. These data will be transferred to MPI Schepens Niemiec’s team after initial 
formatting for secure storage on USC’s protected network and shared drive.  
To reduce the amount of artificial data captured from FitSitt during in-home trials, participants 
will be asked to reframe from allowing anyone else to use the system and to discourage animals from 
Figure 4. Potential FitSitt User 
Interface Displayed on an Attached 
Smart Device. 
Redacted 

 
 
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sitting on the device. Additionally, participants will be queried during the follow-up interviews at 
home-based sessions about any instances that may have caused artificial usage readings. 
 
Activity monitoring and physiological health data captured using ActivPAL, ActiGraph, and/or 
Biostrap, will be downloaded and cleaned upon return to the USC lab. Date-time stamps from the 
ActivPAL data, Biostrap data, ActiGraph data, and the FitSitt sensor data will allow correlation of 
activity and energy expenditure-related measures collected by the three systems. Questionnaires will 
be administered directly through REDCap database management system. REDCap is a secure, web-
based application designed to support data capture for research studies, providing an intuitive 
interface for validated data entry. It also includes audit trails for tracking data manipulation and export 
procedures, automated export procedures for seamless data downloads to common statistical 
packages, and procedures for importing data from external sources. The REDCap website is 
password-protected and restricted to authorized users. All audio/video recordings will be transferred 
from the respective device from which they were recorded onto a password-protected, secure shared 
drive through the USC Chan Division; folders storing such data can only be accessed by authorized 
users. Any data collected in hard copy version that is not transferred to REDCap for electronic storage 
will be scanned in digital format to be stored on the aforementioned shared drive. The hard copies will 
be retained in a locked file cabinet in the USC Chan Division.   
 
To minimize missing data, we will: (a) obtain alternate contact information for each participant 
at study entry; (b) employ one-on-one data collection when appropriate; (c) continuously monitor 
sensor output from FitSitt during in-home (remotely) and in-lab testing, (d) reschedule any missed 
data collection sessions, and (e) testers will receive regular refresher trainings across the study 
assessment periods to ensure they are adhering to all data collection guidelines. All study participants, 
including dropouts, will be described in terms of baseline characteristics. Reasons for missing data 
(e.g., activity monitor failure, participant hospitalization, participant withdrawal) will be documented 
to the extent possible. 
 
Data monitoring will happen throughout the study. At the outset of the study implementation and 
at subsequent one to two-month intervals, Dr. Schepens Niemiec will conduct project staff meetings 
in which all study personnel who have contact with participants will discuss the safety and proper 
treatment of research participants. These meetings will be mandatory. This group will also assess 
participant recruitment, accrual and retention, data quality and timeliness, participant risk versus 
benefit, and the development of external conditions that could potentially affect the study. Significant 
problems or adverse events will be reported immediately to the USC IRB and summarized in a report 
to an NIA-approved safety officer (as described below). Study procedures that negatively affect 
participants will be halted if they present an immediate hazard to participants. Other protocol changes 
will not be made prior to IRB approval. Dr. Schepens Niemiec will discuss any issues that were 
identified as adverse events with research personnel at the subsequent project staff meeting to ensure 
that everyone is informed about events and potential protocol changes. She will also arrange for 
trainings as needed. If data and/or safety issues come to the attention of Dr. Schepens Niemiec 
between meetings, she will intercede as described above.  
 
Data will also be monitored by a safety officer who is separate from the study and product 
development team. This person is a medical doctor, and is required and has been approved by the 
sponsoring funding agency (NIA). The study team must send compiled adverse event reports on a 
regular schedule (commensurate with the level of risk determined by the IRB) to this person for 
review. The team expects that semi-annual reports will be sufficient for this minimal risk study and 
will propose this to the safety officer upon approval from IRB. Dr. Schepens Niemiec will send a data 
and safety monitoring report to the safety officer upon conclusion of the study. 
 
 
5.a.vi. Dissemination of findings 

 
 
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Study findings will be disseminated through various avenues. MPI Schepens Niemiec will lead 
dissemination to the academic community. She, or other members of the research team, will submit 
abstracts to and attend local, regional, and/or national scientific conferences to present findings in oral 
and/or poster format. Additionally, she will lead or oversee papers submitted to peer-reviewed 
scientific journals for publication. Because this funded study is a small business grant, much of the 
study findings will remain confidential to the business partner. All study findings will be presented in 
a way that protects the intellectual property belonging to Activ Sitting, Inc. Findings will also be 
reported in future grant submissions for additional research. 
 
5.b. Instrumentation 
Various instrumentation will be used for each stage of the study at different time points. Table 3 
indicates at which stage and time point each measurement tool is utilized. Details about the tools are 
included in the subsequent sections. Information about the other stages of the study have been removed. 
 
Table 3: Measurement tools and timing of implementation for the in-home stage of the study 
Instrument 
In-home Test 
Standardized Questionnaires 
 
     Brief Pain Inventory – Short Form 
Pre; Post 
     Musculoskeletal Stiffness Questionnaire 
Pre; Post 
     Brief Fatigue Inventory 
Pre; Post 
 Physical Activity Scale for the Elderly (PASE) 
Pre; Post 
 Self-efficacy for Exercise 
Pre 
Study-specific Tools 
 
     Screening, Contact, Referral Form 
Pre-consent 
     Background Questionnaire 
Pre 
     Initial Impression of FitSitt 
Post 
     Self-efficacy for Using FitSitt 
Post 
     Activity Monitor Instructions Log 
Throughout 
Qualitative Tools 
 
     Interview Guide – In-home  
Post 
Additional Tools 
 
     activPAL 
Throughout 
     ActiGraph GT9X-BT 
Throughout 
Notes: Pre = baseline; Pre-consent = prior to consent; Post = after intervention activities; 
Throughout = utilized/conducted during the entirety of a given session or study period 
 
5.b.i. Questionnaires/Survey Measures (names and citations) 
o 
Standardized questionnaires 
• Brief Pain Inventory – Short Form (subscales: severity and pain interference): Pain will be 
assessed using two Brief Pain Inventory – Short Form subscales: severity and pain 
interference. The severity subscale measures amount of pain presently and at its “worst,” 
“least,” and “average” severity. The interference subscale assesses how much a person’s 
pain disrupts everyday life. Both subscales are considered valid and reliable (de Andres 
Ares et al., 2015; Keller et al., 2004; Mendoza et al., 2006). The form takes approximately 5 
minutes to complete. For eligibility purposes, if a person marks >8 on question #3, 5, 6, and 
9c, these will be treated as red flags that will require follow-up to confirm eligibility. 

 
 
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• Musculoskeletal Stiffness Questionnaire: We will measure stiffness using the 
Musculoskeletal Stiffness Questionnaire (Halls et al., 2016; Watson et al., 2020), a 21-item 
form that takes ≤10 minutes to complete. This patient reported outcome measure has been 
used to assess overall joint stiffness as well as the physical and psychosocial impact of 
stiffness on everyday life in healthy adults across the lifespan (Watson et al., 2021). Studies 
include validation of the tool for persons with rheumatoid arthritis (Halls et al., 2016; Halls 
et al., 2018) and chikungunya disease (Watson et al., 2020). For eligibility purposes, if a 
person marks >8 on question #4 this will be treated as a red flag that will require follow-up 
to confirm eligibility. 
• Brief Fatigue Inventory: Fatigue will be measured using the Brief Fatigue Inventory, a 9-
item questionnaire that captures subjective report of fatigue severity. It takes approximately 
5 minutes to complete. This tool demonstrates good psychometric properties and is sensitive 
to change (Mendoza et al., 1999). For eligibility purposes, if a person marks >8 on questions 
#1, 2, and 4c, these will be treated as red flags that will require follow-up to confirm 
eligibility. 
• Physical Activity Scale for the Elderly (PASE): Self-reported physical activity will be 
measured via the PASE (Washburn et al., 1993). This 10-item instrument assesses physical 
activity commonly pursued by older adults, including leisure, household, and occupational 
tasks. The tool is a valid and reliable PA measure in older people (Washburn et al., 1999; 
Washburn et al., 1993) and takes roughly 5 minutes to complete. 
o 
Study-specific questionnaires 
• Screening, Contact, Referral Form: The screening form includes details for each of the three 
stages of the study (i.e., focus group, in-lab, in-home) and will be asked based on which 
stage we are recruiting for at the time. Questions are based on inclusion and exclusion 
criteria for each study stage. Additionally, important demographic details will be asked (i.e., 
age, sex, race/ethnicity, TV watching time) for purposes of recruiting a diverse sample of 
participants as required by the funding sponsors. This screening will be administered as a 
smart form such that select questions will only arise based on individuals’ responses to 
previous questions and stages of study recruitment. The form includes a section for 
participant contact information as well as referral source. 
• Background Questionnaire: Basic demographic, health-related, health behavior, and 
technology use data will be gathered using a study-specific questionnaire to characterize the 
sample. This questionnaire will be administered as a smart form such that questions will 
branch to additional questions based on responses from the individual. The form is expected 
to take approximately 5 minutes to complete. 
• Initial Impressions of FitSitt: Feasibility and acceptability of FitSitt will be assessed using a 
study-specific questionnaire targeting users’ cursory impressions of the system. Users are 
asked a variety of questions targeting issues ranging from perceived ability of the system to 
meet their health needs to the likelihood the system could be integrated into their daily lives. 
The form is expected to take approximately 3 minutes to complete. 
• Self-Efficacy for Using FitSitt scale: FitSitt use self-efficacy will be assessed using a study-
specific adaptation of the Self-Efficacy for Exercise scale (Resnick & Jenkins, 2000). Items 
have been modified to focus on using FitSitt as the mode of SA disruption rather than 
addressing exercise in general terms. The form is expected to take approximately 3 minutes 
to complete. 
• Activity Monitor Log: This log was created to assist the research team in data analysis and 
interpretation of data collected from the activPAL/ActiGraph activity monitors. On this 

 
 
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Revised 06/15/2023 
form the user will document any instances of when the monitors fell or were taken off, 
wake/bed times, and any other comments they would like to include about monitor wear.  
 
 
 
5.b.ii. Qualitative Instruments 
• Interview Guide – In-home [embedded in document “Tester Checklist Collect Home bsl” 
and “Follow-up In-home Interview Guide”]: an audio/video-recorded semi-structured 
interview, informed in part by the Health Information Technology Usability Evaluation 
Model (Yen, 2010), will be conducted to evaluate users’ experience, the training, and 
cursory impressions regarding the system’s feasibility and acceptability. Individuals will be 
queried about such topics as potential efficacy to impact sedentary activity, physical 
activity, and health; perceived facilitators/barriers to adopting FitSitt; and suggestions for 
enhancement. Due to the semi-structured nature of the interviews, the interviewer may 
depart from questions included on the guide in order to probe for pertinent details and 
follow up on information disclosed by the participants. 
 
 
5.b.iii. Additional Instruments 
• activPAL Activity Monitor: The activPAL (Pal Technologies Ltd) activity monitor—a gold-
standard accelerometer device for tracking seated and standing activities in free-living 
conditions (Grant et al., 2006)—will be placed on the user’s thigh for comparison with data 
captured with FitSitt sensors and through video recording. The monitor is approximately 1.5 
square inches and is lightweight. Additional information on the monitor is available here:  
https://www.palt.com/  
• ActiGraph GT9X-BT: The ActiGraph GT9X-BT (ActiGraph, LLC) is a research-grade 
activity tracker within the family of ActiGraph monitoring technology considered to be 
gold-standard products for real-time assessment of movement. The device can be worn on 
multiple parts of the body ranging from the wrist to the ankle and has an option for showing 
activity feedback, which we will not activate for this study’s purposes. Additional 
information about this device can be found here: https://theactigraph.com/actigraph-link. 
We intend to place the device on the user’s lower body (ankle or attached to their shoe) as 
we hypothesize this will be the most likely location that will reliably capture the 
reciprocating movements required during FitSitt use.  
 
5.c. Data Analysis 
 
For the focus group, in-lab, and in-home testing phases of the study, procedures primarily 
include ones that are non-experimental or qualitative in nature, thus non-statistically driven data 
analyses will be conducted. These results are not reported in the clinicaltrials.gov and thus the analyses 
are not described here.  
 
The various study stages will also include collection of a background/demographic profile 
comprised of factors such as age, sex, race, ethnicity, other demographic characteristics, health-
tracking habits, and household income, and access to in-home Wi-Fi. Activity profile data will also be 
collected using self-report questionnaires addressing physical activity level and self-efficacy to use 
FitSitt. Activity and health monitor data (for in-lab and in-home stages) for assessment purposes will 
come from the research-grade activity monitor (ActivPAL and/or ActiGraph). Health and well-being 
indices include factors such as ongoing health problems, health status, BMI (height and weight), pain 
severity, pain interference, fatigue, and stiffness. Markers of acceptability of FitSitt are comprised of 
factors such as initial impressions of FitSitt, and address issues such as perceived engagement, and 
functionality. FitSitt usage data (for in-lab and in-home stages) will be obtained primarily from 
embedded sensors in the FitSitt system. Descriptive statistical analysis on all these variables will be 
generated for each sample and within key strata such as sex and age group (65–84, 85+) to characterize 

 
 
16 
 
Revised 06/15/2023 
the samples.  
 
In-home testing data related to activity, physiological parameters, and FitSitt usage patterns will 
only include activity that takes place during waking hours, as determined by ActivPAL’s (and/or 
ActiGraph’s) proprietary algorithm and corroborated by participant activity monitor logs. We will 
capture and report descriptive statistics on factors such as: sitting/lying behavior (total duration 
sitting/lying per day, mean duration of individual sitting/lying bouts over the day, number of 
sitting/lying bouts per day, number of sit-to-stand transitions per day), and activity level (total sedentary 
time [ActivPAL/ActiGraph proprietary algorithm], total step counts per day, total stepping time per 
day). Objective FitSitt usage data will be aggregated to produce meaningful summaries of chair usage, 
such as: seat occupancy (total duration sitting in FitSitt per day, duration of FitSitt sitting bouts per day), 
treadle usage (duration of pedaling bouts per day, frequency of pedaling bouts per day, total time 
pedaling per day, mean speed during daily pedaling bouts), synchro-tilt/recline usage (number of times 
recliner is engaged per day, mean duration of recliner engagement per day). Additionally, pain, fatigue, 
stiffness, and physical activity/sedentary activity behaviors (self-reported and objective) will be collected 
both pre-use of the system and at the conclusion of the study. Pre-post scores will be compared, for 
exploratory purposes, using a paired samples t-test (or Wilcoxon signed-rank test) to indicate changes, if 
any, after having FitSitt in the home for a short time. Additionally, we will explore the association of 
FitSitt adherence (minutes of treadle usage dichotomized at the median) to confidence to use FitSitt 
using Spearman correlation. Normalizing transformations will be applied to variables as appropriate; 
sparse data may be recoded to dichotomous or ordinal data. 
 
Power Analysis 
The purpose of this study is to continue FitSitt development, and to test the feasibility of study 
procedures that would be used in a larger study investigating the efficacy of the system to decrease 
sedentariness in older adults. Accordingly, power calculations are not appropriate. However, sample 
sizes chosen for each stage of testing are justifiable based on previous research. Iterative product 
development requires only small samples—5 to 20 users per prototype iteration (Faulkner, 2003)—
justifying our modest sample sizes of N=15–30. The additional participants beyond the high end of the 
recommended range will increase chances of identifying lower-level usability issues (Faulkner, 2003; 
Virzi, 1992). The data from this pilot study will elicit rich information for a properly powered, more in-
depth study in Phase II.  
 
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