Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology
Phase: NA
Conditions: Alzheimer Disease, Dementia, Gamification, Assistive Technology
Sponsor: MapHabit, Inc.

Umbrella Study to Evaluate the Feasibility of 
Collecting User Interaction Data in Participants 
Using MapHabit Software 
 
Protocol Number: MH001 
National Clinical Trial (NCT) Identified Number:  NA 
Principal Investigator: Stuart Zola, PhD 
Funded by: National Institute of Health / MapHabit, Inc. 
Version Number:  v.0.5 
09 July, 2024 Summary of Changes from Previous Version: 
 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
6.5; 
additions to 
section 16 
Additional questionnaires and 
assessments that may be included in 
sub-studies of the umbrella protocol 
Subsequent sub-studies may include 
additional questionnaires and 
assessments that evaluate more specific 
aspects of outcomes than previous 
instruments.  
6.5; 
additions to 
section 16 
Additional questionnaires and 
assessments that may be included in 
sub-studies of the umbrella protocol 
Subsequent sub-studies may include 
additional questionnaires and 
assessments that evaluate more specific 
aspects of outcomes than previous 
instruments.  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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1. 
Protocol Summary 
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1.1. 
Synopsis 
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1.2. 
Schedule of Activities 
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2. 
Introduction 
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2.1. 
Study Background and Rationale 
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2.2. 
Description of the MapHabit Software used in Sub-studies 
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3. 
Objectives and Outcomes 
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4. 
Study Design 
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4.1. 
Treatment Assignment 
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5. 
Study Population 
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5.1. 
Inclusion Criteria 
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5.2. 
Exclusion Criteria 
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5.3. 
Withdrawal Criteria 
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5.4. 
Screen Failures 
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6. 
Study Methods 
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6.1. 
Participants Joining the Umbrella Study from Sub-Study 
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6.2. 
Pre-recruitment 
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6.3. 
Enrollment: Day 0 
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6.4. 
Data Collection Period 
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6.5. 
Follow Up Assessments 
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7. 
Statistical Considerations 
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7.1. 
Sample Size Determination 
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8. 
Subject Accountability 
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8.1. 
Withdrawal 
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9. 
Safety 
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9.1. 
Risk/Benefit Assessment 
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9.1.1. 
Known Potential Risks 
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9.1.2. 
Known Potential Benefits 
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9.1.3. 
Assessment of Potential Risks and Benefits 
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9.2. 
Unanticipated Problems 
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9.2.1. 
Definition of Unanticipated Problems (UP) 
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9.2.2. 
Unanticipated Problem Reporting 
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9.2.3. 
Serious Adverse Event (SAE) Reporting 
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9.2.4. 
Adverse Device Event Reporting 
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9.3. 
Death Reporting 
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10. 
Informed Consent 
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10.1. 
Assessment of Capacity for Informed Consent 
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10.2. 
Process of Obtaining Informed Consent Through Surrogacy 
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11. 
Protocol Deviations 
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12. 
Study Discontinuation and Closure 
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13. 
Data Management 
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13.1. 
Data analysis plan 
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13.2. 
Quality control 
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13.3. 
Data handling 
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13.4. 
Data Collection 
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13.5. 
Study Records Retention 
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14. 
Abbreviations 
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15. 
Statement of Compliance 
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16. 
Potential Sub-Study Surveys & Questionnaires 
25 
17. 
Assent Form 
100 
18. 
References 
104 
 
 

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1. Protocol Summary 
1.1. 
Synopsis 
Title 
Umbrella Study to Evaluate the Feasibility of Collecting User Interaction Data in Participants 
Using MapHabit Software 
 
Study Description 
This is a multi-center, prospective, observational, sample collection/methods development study, 
with continuous user interaction data collection. 
 
Objectives 
A. Primary Objective:   
● Demonstrate the feasibility of collecting user interaction data in participants using 
MapHabit software 
 
B. Exploratory Objective: 
● For AD/RD: Develop measures to qualify and quantify disease progression and 
severity based on the collected user interaction data. Participants will be expected 
to utilize the MapHabit application either independently or with the assistance of a 
caregiver/LAR depending on the capacity of the participant. 
● For DS: Develop measures to qualify and quantify independence and improvements 
in quality of life. Participants will be expected to utilize the MapHabit application 
under the supervision of the parent or legal guardian.  
 
Endpoints 
A. Primary Endpoint: 
●  Availability of user interaction data 
● A set of sub-study specific questionnaires at the start and end of the intervention 
 
B. Exploratory Endpoint:  
● Mathematical model to establish a relationship between: behaviors while operating 
a mobile device as measured by user interaction data collected during this study, 
and disease severity and progression as measured in subsequent sub-study(ies) 
conducted by MapHabit Inc.  
 
Inclusion, Exclusion and Withdrawal Criteria: 
A. Inclusion Criteria:  

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● For Adult population with AD, ADRD, TBI, MCI, or other form of cognitive 
impairment: Female or male subjects must be over the age of 18.  A legally 
authorized representative (LAR) must sign on behalf of the subject if the subject 
does not have the capacity to consent  
● For Down Syndrome Population: Females and males 5-17 years of age. Parents 
or Legal guardians must sign for subjects under the age of 18 
● A clinical diagnosis of Alzheimer’s Disease (AD), Alzheimer’s Disease Related 
Dementia (ADRD), Mild Cognitive Impairment (MCI), Traumatic Brain Injury 
(TBI), other forms of cognitive impairment OR a diagnosis of Down Syndrome 
(DS) OR a caregiver of an individual within the two populations above 
● Candidate participants over the age of 18 with clinical diagnosis of AD/ADRD, 
MCI, TBI, or other form of cognitive impairment OR Down Syndrome are 
screened for capacity to provide Informed Consent (see Section 10) 
● Informed Consent obtained from candidate participant or legally authorized 
representative (LAR), parent, or legal guardian as appropriate 
 
B. Exclusion Criteria: 
● Candidate participants with capacity and unwilling to provide Informed Consent 
for this study, or candidate participants without capacity and unable to provide 
Informed Consent through surrogacy, are excluded from enrollment 
 
C. Withdrawal Criteria: 
● Withdrawal of Informed Consent 
● For caregivers of individuals with AD/ADRD, MCI, TBI, or other form of 
cognitive impairment: dissolution of a suitable patient-caregiver relationship 
 
Study Population: 
The maximum number of participants enrolled in the study is 1000. The participants will be using 
the MapHabit software in scope of MapHabit Inc. sub-studies.  
Cohort 1: Must be 18 years of age or older at the time of consent. This study will enroll individuals 
with cognitive impairments (n=<300) and the caregivers of individuals with cognitive impairment 
(n ~ 250). Caregivers may be associated with more than one individual. Enrolled individuals with 
cognitive impairment must have had a previously established clinical diagnosis of Alzheimer’s 
Disease (AD), Alzheimer’s Disease Related Dementia (ADRD), Traumatic Brain Injury (TBI), 
Mild Cognitive Impairment (MCI) or other forms of cognitive impairment. 
 
Cohort 2 (Amended Population): Must be between the ages of 5-17 years old at the time of the 
study. This study will enroll individuals n =< 250 and the primary caregiver/parent of individuals 
with Down Syndrome (DS) (n ~ 250). Enrolled individuals with DS must have a previously 
established clinical diagnosis of DS. A parent or legal guardian must consent for subjects under 
the age of 18 and supervise the child’s use of the system. 
 

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Recruitment 
Study participants will be recruited from the general public and within the MapHabit software. 
Recruitment material that is provided in-person, digitally, or through the MapHabit software will 
include: 
 
● Purpose of the study 
● Expectation of the participants 
● Time commitment for participating 
● Location where research is taking place 
 
Compensation is offered for participation, with the monetary amount depending on the sub-study. 
Monetary amount is based on the duration of the sub-study. Compensation will range from $50 to 
$200. Recruitment material presented within the MapHabit software will have design elements 
(e.g., font size, color, graphics) consistent with the remainder of the software interface. 
Reimbursement will be provided for expenses, including transportation to initial or exit interview, 
which may be incurred related to this study. The MapHabit System will be offered to participants 
during this study at no cost to the participants or families of the participants during the course of 
this study. 
 
Description of Study Intervention: 
This umbrella study does not introduce any intervention other than the utilization of the MapHabit 
System during the specified period of the sub-study. Furthermore, subsequent MapHabit Inc. sub-
studies may measure or collect cognitive and health outcomes of all study participants. The user 
interaction data collected in this umbrella study and clinical outcomes data—including protected 
health information (PHI)—collected in subsequent sub-studies can be analyzed in combination to 
generate a mathematical model demonstrating the relationship between these two types of 
measurements. It is hypothesized that such a mathematical model may be used to forecast future 
changes in cognition and health based on behaviors while operating a mobile device. This forecast 
may be used by clinicians to guide changes in medical and behavioral therapy, hospital systems 
and insurers to identify at-risk and high utilization patients, and individuals with cognitive 
impairment and family members better prepare emotionally and financially for the future. With 
the recent development of gamification—the application of game playing elements—within the 
MapHabit system, subsequent sub-studies may measure how user engagement is impacted by the 
introduction of virtual reality aspects that is associated with the MapHabit system.  
 
Participant Duration: 
This umbrella study protocol does not require a minimum or maximum duration of study 
participation. The duration of participation in a research study will be defined by subsequent 
MapHabit, Inc. sub-study(ies) in which the subjects or their LAR, parent/legal guardian (where 

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applicable) will participate in an exit interview at the end of the study. The study will be completed 
once the maximum number of participants complete the study. Participants in the AD/RD sub-
study population will be expected to use the MapHabit System daily for 6 months. Participants in 
the DS sub-study population will be expected to use the MapHabit System for 3-6 months.  
Participants may use the MapHabit System for up to 2 years, in which data will be passively 
collected with no additional expectations of the users. 
 
1.2. 
Schedule of Activities 
Study Activity 
Enrollment 
(Day 0) 
Continuously 
End of 
Participation 
Inclusion/Exclusion screening 
X 
 
 
Participant completes enrollment to 
this study within the MapHabit 
software 
X 
 
 
Participant is evaluated for ability to 
provide Informed Consent 
X 
 
 
Informed Consent is provided by 
participant or consenting legally 
authorized representative 
X 
 
 
Assignment of unique participant 
number 
X 
 
 
Initial Baseline Interview with sub-
study appropriate questionnaire or 
survey  
X 
 
 
Passive data collection 
 
X 
 
Evaluation of Withdrawal Criteria 
 
X 
 
Study completion 
 
 
X 
Exit Interview with sub-study 
appropriate questionnaire or surveys 
throughout study 
 
 
X 
Post intervention survey as appropriate 
for sub-study 
 
 
X 
 

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2. Introduction 
2.1. 
Study Background and Rationale 
As Alzheimer’s disease (AD) progresses, an increasing rate of atrophy is seen in the hippocampus 
[1] while the neostriatum is preserved [2]. The neostriatum is responsible for the development and 
retention of procedural memory, such as routines and habits. 
Down Syndrome (DS) occurs in one in 700 live births. In addition to intellectual disability, people 
with DS are very likely to eventually develop AD. 70% of people with DS develop the neuro-
pathophysiology associated with AD by their 40s, and current research suggests that there could 
be common pathogenic mechanisms [6]. Importantly, such mechanisms primarily manifest as 
learning disabilities in children with DS, involving mild to moderate cognitive impairment [7]. 
Evidence suggests early intervention that address cognitive, language, and social-emotional needs 
of children with DS can promote child development. Specifically, engagement in strongly 
responsive interactions with daily routines induce the child’s use of various pivotal developmental 
behaviors, such as attention, initiation, and persistence [8]. 
 
The MapHabit software was developed as an assistive technology for individuals living with AD, 
Alzheimer’s disease related dementias (ADRD), and their caregivers. This technology utilizes 
aspects of visual mapping to enhance the ability of memory impaired individuals to live 
independently. Visual mapping is a learning technique to diagram relationships between ideas and 
memories. Despite remarkable success across a wide range of disciplines, there is nothing to 
deliver the capabilities of visual mapping for individuals living with cognitive impairment. 
Currently commercial visual mapping software is too complicated for users with memory, 
cognitive, and physical impairments and are not easily adaptable. The MapHabit software 
combines features of mind mapping with a dynamically responsive user interface to assist 
individuals, caretakers, and clinicians. 
Here we propose an umbrella trial to evaluate the feasibility of collecting information about user 
interactivity with the MapHabit software interface. This data has the potential to be used for further 
development of the MapHabit software and developing measures of disease severity, progression, 
and independence. 
2.2. 
Description of the MapHabit Software used in Sub-studies 
By engaging with the MapHabit software, a user can develop and utilize visual maps to show 
schedules and activities of daily living (ADL). Visual mapping is a technique to enhance learning 
and memory that has been studied previously in cognitive intact populations [3][4]. It is 
hypothesized that the use of the visual maps will enhance the ability of patients with cognitive 
impairment to improve the quality of their life (QoL). The visual maps are personalized for each 
individual, created specifically for activities requiring additional assistance, and serve as a constant 
and available reminder of important information. The gamification of the visual maps mentioned 
above is a part of the continuing development and improvement of the software, with virtual reality 
implementation being a part of the gamification initiative. These additions can potentially elevate 
the experience of the MapHabit software.  

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After repeated use of the MapHabit software, individuals with impaired memory can develop a 
habit of routinely using visual maps to independently manage their daily activities. Doing so 
alleviates dependence of individuals with cognitive impairment from their caregivers. Benefits of 
the MapHabit software include, but are not limited to, reduced levels of stress, agitation, confusion, 
frustration, and anger. Individuals become less reliant on caregivers and family members, 
achieving more autonomy in daily living. Stress and burden experienced by caregivers and family 
members are significantly reduced, improving QoL for all parties involved. 
3. Objectives and Outcomes 
OBJECTIVES 
OUTCOMES 
JUSTIFICATION FOR OUTCOMES 
Primary Objective 
  
  
Demonstrate the feasibility of 
collecting user interaction data 
in participants using MapHabit 
software 
Availability of user interaction data 
We want to demonstrate that the data 
collection is technically feasible, and the 
structure of the collected data is suitable 
for analysis and measure development 
Exploratory Objective 
  
  
Develop measures of disease 
severity, progression, 
independence and quality of life 
with AD/RD participants based 
on the collected user interaction 
data. For DS participants, this 
study also hopes to develop 
measures for independence and 
quality of life based on the 
collected user interaction data 
  
Mathematical model to establish a 
relationship between behaviors 
while operating a mobile device (as 
measured by user interaction data) 
and clinical disease severity and 
progression (as measured by PHI in 
subsequent sub-studies) 
We hypothesize that a subject’s behavior 
within the software is affected by 
clinical severity and progression of 
disease and/or may influence the 
subject’s independence, quality of life, 
or other outcomes as measured by the 
sub-study specific questionnaires or 
surveys. 
4. Study Design 
Study Design for the ADRD Population: 
This is a multi-center, prospective, observational, sample collection/methods development study, 
with continuous user interaction data collection. This study will enroll two groups of participants: 

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1. Individuals (n =<300) with a diagnosis of AD, ADRD, TBI, MCI, DS or other form of 
cognitive impairment. Individuals will participate in sub-study relevant surveys and 
questionnaires if they have the capacity to do so throughout the study period.  
2. Caregivers OR Legally Authorized Representatives (n ~ 250) of enrolled individuals. One 
caregiver may be assigned to several individuals. Caregivers will participate in sub-study 
surveys if the individual does not have the capacity to do so. 
Study Design for the DS Population: 
This is a multi-center, prospective, observational, sample collection/methods development study, 
with continuous user interaction data collection. This study will enroll two groups of participants: 
1. Individuals (n =< 250) between the ages of 5-17 with a diagnosis DS 
2. Parents/Legal Guardians (n ~ 250) of the enrolled individuals. Parents must complete 
surveys and questionnaires on the behalf of the individual throughout the study period. 
 
Study participants will engage with the MapHabit software through a mobile device (e.g., smart 
phone or tablet) equipped with MapHabit software. This study will collect measures of participant 
engagement within the MapHabit software via Google Analytics for Firebase platform. The 
collected data is then transferred to a cloud computing platform for processing and further analysis. 
Data originating from Google Firebase will be encrypted in transit using TLS/SSL and encrypted 
at rest using the AES-256 encryption algorithm. The following data types will be collected:   
1. Dwell time: the duration of time that an element of the software interface is displayed to 
the participant without any further interaction. This can be further segmented to: 
a. Screen dwell time 
b. Prompt dwell time 
2. User input: actions (e.g., tapping, swiping, typing) with all interactive elements (e.g., 
buttons, dialog box) within the MapHabit software will be recorded with an element 
identifier and time of interaction 
3. Application logs, such as error reports, unexpected shutdowns, etc. 
Within sub-studies conducted by MapHabit, inc., clinical outcomes data, including electronic 
medical records and other PHI of participants, may be transmitted to MapHabit, inc. by partnering 
sites (i.e., Senior Living facilities) and examined retrospectively to analyze in combination with 
user interaction data in generating a mathematical model demonstrating their relationship. 
Within sub-studies conducted by MapHabit, inc., virtual reality components may be implemented 
to a small subset of participants to examine how the addition of virtual reality gamification may 
influence the current user interaction data seen in the MapHabit software. The virtual reality is a 
supplemental or exploratory condition to examine whether modern game elements can enhance 
user interaction and engagement with the MapHabit system. Participants are considered enrolled 
in this study after providing Informed Consent. Informed Consent may be obtained in writing or 
electronically. 
The study will consist of three parts: 
1. Enrollment in study (day 0) 

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2. Continuous data collection 
3. End of participation 
This umbrella study protocol does not require a minimum or maximum duration of study 
participation. The duration of participation in a research study will be defined by subsequent 
MapHabit, Inc. sub-study(ies) for participants with ADRD and separately for children with DS 
and their parents or legal guardians. The study will be completed once the maximum number of 
participants complete the study. The MapHabit System is easy to setup upon beginning the study 
and all participants will undergo an initial onboarding training virtually or in-person. 
4.1. 
Treatment Assignment 
Any participant meeting all inclusion criteria is eligible for enrollment in this study. Participants 
are considered enrolled in this study after providing Informed Consent. Informed Consent may be 
obtained in writing or electronically. 
5. Study Population 
The maximum number of participants enrolled in study this 1000. Participants in the first study 
population cohort are individuals with clinical diagnosis of AD, ADRD, TBI, MCI, or other form 
of cognitive impairment; and/or their respective caregivers; who are using the MapHabit software 
in scope of MapHabit sub-studies. All participants are at least 18 years of age on day of consent. 
No further demographic information regarding sex, gender, race, and location, income, marital 
status, or living situation is defined at this time. The study will enroll individuals with cognitive 
impairment (n = 250) and caregivers of individuals with cognitive impairment (n ~ 250). All 
individuals with cognitive impairment will have a clinical diagnosis of AD, ADRD, TBI, MCI, or 
other form of cognitive impairment. We will also be collecting data from caregivers as appropriate 
for sub-studies. 
 
The second study cohort will feature individuals with a clinical diagnosis of DS; and/or their 
respective caregivers; who are using the MapHabit software in scope of MapHabit sub-studies. 
Subjects must be at least 5 years of age on the day of consent. No further demographic information 
regarding sex, gender, race, location, income, or living situation is defined at this time. This study 
will enroll individuals with a clinical diagnosis DS (n ~ 250) with the supervision of their 
parents/legal guardians. 
5.1. 
Inclusion Criteria 
● For Adult population with AD, ADRD, TBI, MCI, or other form of cognitive 
impairment: Female or male subjects must be over the age of 18.  A legally 
authorized representative (LAR) must sign on behalf of the subject if the subject 
does not have the capacity to consent 

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● For Down Syndrome Population: Females and males between 5-17 years of age. 
Parents or Legal guardians must sign for subjects under the age of 18. 
● A clinical diagnosis of Alzheimer’s Disease (AD), Alzheimer’s Disease Related 
Dementia (ADRD), Mild Cognitive Impairment (MCI), Traumatic Brain Injury 
(TBI), Down Syndrome (DS) other forms of cognitive impairment, OR a caregiver 
of an individual with a diagnosis listed above 
● Candidate participants with clinical diagnosis of AD/ADRD, MCI, TBI, or other 
form of cognitive impairment are screened for capacity to provide Informed 
Consent (see Section 10) 
● Informed Consent obtained from candidate participant or legally authorized 
representative (LAR), parent or legal guardian as appropriate 
 
5.2. 
Exclusion Criteria 
● Candidate participants with capacity and unwilling to provide Informed Consent 
for this study, or candidate participants without capacity and unable to provide 
Informed Consent through surrogacy, are excluded from enrollment 
 
5.3. 
Withdrawal Criteria 
● Withdrawal of Informed Consent 
● For caregivers of individuals with AD/ADRD, MCI, TBI, or other form of cognitive 
impairment: dissolution of a suitable patient-caregiver relationship 
 
5.4. 
Screen Failures 
Subjects who are screened that do not meet inclusion criteria will not be enrolled 
in the trial. 
6. Study Methods 
6.1. 
Participants Joining the Umbrella Study from Sub-Study 
All participants in any MapHabit, Inc. sub-study engaging with MapHabit software will be offered 
enrollment in this umbrella study at the time of enrollment to the respective sub-study. User data 
from participants not enrolled in this study will be handled according to protocols set forth by the 
MapHabit, Inc. sub-study(ies) the subject may be enrolled in. User data from subjects not enrolled 
in this umbrella study or subsequent sub-study(ies) will not be collected.  

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6.2. 
Pre-recruitment 
No pre-recruitment activities. 
6.3. 
Enrollment: Day 0 
After creating the account, the subjects proceed to enrollment process, which consists of 2 steps: 
1.) Inclusion/Exclusion Criteria Assessment and sub-study relevant pre-assessment 
questionnaires  
a.) Performed by trained and qualified study personnel  
 
2.) Signing of Electronic Informed Consent Form (eICF) and HIPAA Waiver 
Please refer to the RESEARCH CONSENT FORM 
6.4. 
Data Collection Period 
Participants will not take part in any assessment during the data collection period of the umbrella 
study. There is no predefined minimum data collection period. User interaction data will be 
passively collected during the time the participant engages with the software. For sub-studies that 
involve retrospectively examining clinical outcomes data and PHI of participants, data will be 
de-identified and collected only during the time the participant engages with the software. For 
MapHabit sub-studies amongst the AD/RD population, participants and their caregivers will be 
expected to use the MapHabit System daily for 6 months. For MapHabit sub-studies amongst the 
DS population, children will need to use the MapHabit system daily for 3-6 months under the 
supervision of a parent or legal guardian. The maximum duration for passive user interaction 
data collection is two years. Parent(s) or legal guardians will be administered a periodic 
assessment on a monthly basis throughout the study in addition to the baseline assessments and 
the exit interviews for specific sub-studies that will occur at the end of the study period. 
 
6.5. 
Follow Up Assessments 
No follow up assessments are included in this umbrella protocol. Participants of this study may 
undergo follow up assessments or questionnaires in accordance with subsequent MapHabit, Inc. 
sub-study(ies) the participant may be enrolled in. Samples of all assessments are included within 
this document. Baseline, Periodic, and Post Follow-up assessments for a sub-study amongst 
individuals with AD/RD may include: 
· 
Quality of Life in Alzheimer’s Disease 
· 
Zarit Burden Interview 
· 
Pittsburgh Sleep Quality Index (PSQI) 
· 
The Lawton Instrumental Activities of Daily Living Scale 
· 
Neuropsychiatric Inventory (NPI) Questionnaire 

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· 
The Montreal Cognitive Assessment (MOCA) 
· 
The Medication Management Instrument for Deficiencies in the Elderly (MedMaIDE) 
· 
Geriatric Depression Scale 
· 
Pain Assessment in Advanced Dementia Scale (PAINAD) 
· 
Caregiver Self-Assessment Questionnaire 
· 
MapHabit, Inc. Final Exit Interview Questionnaire 
· 
Brief Interview for Mental Status – (BIMS) [Sample not included] 
· 
Wisconsin Quality of Life Caregiver Questionnaire 
· 
Pain and Sleep Questionnaire 
· 
Patient Health Questionnaire (PHQ9) 
· 
Generalized Anxiety Disorder Scale (GAD7) 
· 
Anger Management Scale 
· 
Caregiver Self-Assessment Questionnaire 
· 
Bristorl Activities of Daily Living Scale (BADLs) 
Net Promoter Scale QuestionnaireBaseline, Periodic and Post Follow-up assessments for a sub-
study amongst individuals with DS may include: 
· 
MapHabit, Inc Final Exit Interview Questionnaire 
· 
LuMind Down Syndrome Caregiver Assessment 
· 
Vineland-3 
· 
Neuropsychiatric Inventory (NPI) Questionnaire  
· 
Adaptive Behavior System Third Edition (ABAS-3) [Sample not included] 
· 
Child Behavior Checklist (CBCL) [Sample not included] 
· 
Behavior Problem Inventory (BPI-01) 
 
7. Statistical Considerations 
No inferential statistical evaluation is foreseen in the scope of this study. Data will be listed and 
summarized by means of descriptive statistics in tabular and graphical formats.  
7.1. 
Sample Size Determination 
Approximately 250 individuals with cognitive impairment and 250 caregivers of individuals with 
AD/RD will be enrolled in this umbrella study. Approximately 250 children with DS under the 
supervision of parents or legal guardians will be enrolled in this umbrella study. No formal sample 
size calculations were performed, as this is non-interventional, observational research. The number 
of participants was chosen based on feasibility and is considered sufficient to meet the study 
objectives and for potential sub-studies. 
 

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8. Subject Accountability 
Subjects who meet eligibility criteria and agree to participate in this study will be given an 
Informed Consent form, in writing or electronically, approved by an Institutional Review Board 
(IRB). 
 
All subjects who meet eligibility criteria and endorse the Informed Consent form are considered 
enrolled in this study. Subjects enrolled in this study are followed in accordance with this umbrella 
protocol.  
8.1. 
Withdrawal 
If a participant is withdrawn from this study, the reason(s) for withdrawal will be reported to the 
study data collection system. Data collected up to the point of withdrawal will be used for analysis 
and retained per protocol. No further user interaction data will be collected from the participant 
following their withdrawal. 
 
9. Safety 
9.1. 
Risk/Benefit Assessment 
9.1.1. 
Known Potential Risks 
There are no known potential risks and/or discomforts associated with the passive collection of 
user interaction measures through software. For minors involved in the DS population, parental 
supervision and assent is required. Administrative and technical safeguards in accordance with 
HIPPAA standards are in place to secure the confidentiality of electronic clinical outcomes data 
and protected health information (PHI), including de-identification, tracking system, recovery 
plan, and an established security system. For the virtual reality component in some sub-studies, 
there may be risks of dizziness and disorientation while interacting with the software. Safeguards 
are in place to ensure that participants have the choice to take a break or fully stop from engaging 
with virtual reality.  
 
9.1.2. 
Known Potential Benefits 
Potential benefits are currently unknown. Data contributed as part of this study may benefit further 
development of the MapHabit software and research in cognitive impairment and may lead to 
development of diagnostic or therapeutic interventions in the future. 
  

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9.1.3. 
Assessment of Potential Risks and Benefits 
Overall, the known risks involved in participation are minimal. When desired, study participants 
may revoke their consent at any time 
9.2. 
Unanticipated Problems 
9.2.1. 
Definition of Unanticipated Problems (UP) 
The Office for Human Research Protections (OHRP) considers unanticipated problems involving 
risks to participants or others to include, in general, any incident, experience, or outcome that 
meets all of the following criteria: 
  
● Unexpected in terms of nature, severity, or frequency given (a) the research procedures 
that are described in the protocol-related documents, such as the Institutional Review Board 
(IRB)-approved research protocol and Informed Consent document; and (b) the 
characteristics of the participant population being studied. 
● Related or possibly related to participation in the research (“possibly related” means there 
is a reasonable possibility that the incident, experience, or outcome may have been caused 
by the procedures involved in the research); and 
● Suggests that the research places participants or others at a greater risk of harm (including 
physical, psychological, economic, or social harm) than was previously known or 
recognized. 
  
This definition could include an unanticipated adverse device effect, any serious adverse effects 
on health or safety or any life-threatening problem or death caused by, or associated with, a device, 
if that effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or application), 
or any other unanticipated serious problem associated with a device that relates to the rights, safety, 
or welfare of subjects (21 CFR 812.3(s)). 
9.2.2. 
Unanticipated Problem Reporting 
The principal investigator (PI) will report unanticipated problems (UPs) to the selected commercial 
Institutional Review Board (IRB) and to the sponsor. The UP report will include the following 
information: 
  
● Report date, IRB Study number, Study Title, Study Staff Contact Information, Date UP 
occurred, and date PI was notified about the UP. 
● Description of the Unanticipated Problem which occurred during the conduct of the 
research. 
● Provide an explanation for why this Unanticipated Problem occurred. 
● Characterize the impact of the Unanticipated Problem on the study. 

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● Describe the steps which have been taken to resolve the reported occurrence. 
● Describe the plan implemented to avoid or prevent future occurrences. 
● Inform other study participants as necessary. 
● Name all other entities to which this UP has been reported. 
● Determine if the UP will require modification of the currently approved study and/or 
consent form. 
 
Technical issues occurring during the application use can be reported via email 
support@maphabit.com. 
 
9.2.3. 
Serious Adverse Event (SAE) Reporting 
A Serious Adverse Event (SAE) is an untoward occurrence in human research that results in death, 
a life-threatening experience, inpatient hospitalization, prolongation of hospitalization, persistent 
or significant disability or incapacity, congenital anomaly, or birth defect, or that requires medical, 
surgical, behavioral, social, or other intervention to prevent such an outcome (21 CFR 312.32(a)).  
 
Adverse events and deaths occurring in the course of an approved study that are serious, 
unanticipated and related or probably related to the research, by the judgment of the investigator, 
will be reported to the IRB.  
 
If the event satisfies ALL three of these criteria the event must be reported to the IRB within 5 
business days of learning of the event. The study sponsor will also be notified within the same 
timeframe. 
 
9.2.4. 
Adverse Device Event Reporting 
An investigator shall submit to the sponsor and to the reviewing Institutional Review Board (IRB) 
a report of any unanticipated adverse device effect occurring during an investigation as soon as 
possible, but in no event later than 10 working days after the investigator first learns of the effect 
(21 CFR 812.150(a)(1)), A sponsor who conducts an evaluation of an unanticipated adverse device 
effect under 812.46(b) shall report the results of such evaluation to the Food and Drug 
Administration (FDA) and to all reviewing IRB's and participating investigators within 10 working 
days after the sponsor first receives notice of the effect. Thereafter the sponsor shall submit such 
additional reports concerning the effect as FDA requests (21 CFR 812.150(b)(1)).  
9.3. 
Death Reporting 
Death is reported as is stated in section 9.2.3 Serious Adverse Event (SAE) Reporting.  

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A death that meets all three criteria for an SAE, as above, shall be reported by Study Staff to the 
IRB within 5 business days of learning of the death.  A detailed narrative or death letter may be 
requested by the sponsor including date of death, place, circumstances, cause of death, and whether 
the death was witnessed or not. 
 
10. Informed Consent 
Subject participation in this clinical study is voluntary.  Informed Consent is required from each 
subject. The Investigator is responsible for ensuring that Informed Consent is obtained prior to the 
use of any investigational devices, study-required procedures and/or testing, or data collection. 
Informed Consent in this study will be obtained in writing during a face-to-face encounter with 
the study investigator or clinical coordinator, or electronically through a website or within the 
MapHabit software. For participants under the age of 18, a parent of legal guardian must sign on 
behalf of the participant. An assent form for DS participants will be provided to inform and teach 
about the significance of the sub-study participants that are minors. 
  
The obtaining and documentation of Informed Consent must be in accordance with the principles 
of the Declaration of Helsinki, ISO 14155, any applicable national regulations, and local IRB. The 
ICF must be accepted by the sponsor and approved by the IRB. 
  
The process of obtaining Informed Consent shall at a minimum include the following steps, as 
well as any other steps required by applicable laws, rules, regulations and guidelines: 
● include a description of all aspects of the clinical study that are relevant to the subject’s 
decision to participate throughout the clinical study, 
● avoid any coercion of or undue influence of subjects to participate, 
● not waive or appear to waive subject’s legal rights, 
● use native language that is non-technical and understandable to the subject or his/her legal 
representative, 
● provide ample time for the subject to consider participation and ask questions, if necessary, 
ensure important new information is provided to new and existing subjects throughout the 
clinical study. 
  
Consent forms describing in detail the study intervention, study procedures, and risks are given to 
the participant and written documentation of Informed Consent is required prior to starting 
intervention/administering study intervention.  

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10.1. 
Assessment of Capacity for Informed Consent 
All candidate participants with a clinical diagnosis of AD/ADRD, MCI, TBI, or other form of 
cognitive impairment are screened using the University of California San Diego Brief 
Assessment of Capacity to Consent (UBACC) [5]. The UBACC has a 10-item scale, including 
questions that focus on understanding and appreciation of the disclosed research information. In 
cases where screening with the UBACC suggests that a candidate participant may lack adequate 
capacity to consent, Informed Consent may be gathered from a legally authorized representative. 
All research staff administering the UBACC will undergo training to gain familiarity with the 
UBACC scoring system prior to administering the screening test.  
10.2. 
Process of Obtaining Informed Consent Through Surrogacy 
Informed Consent may be gathered from a legally authorized representative (LAR), parent, or 
legal guardian in cases where screening suggests that a candidate participant may lack adequate 
capacity to consent or is under the age of 18. In such cases, the consent interview with the LAR 
may be conducted in-person or over the phone. In cases where the consent interview is 
conducted by phone, a copy of the RESEARCH CONSENT FORM is first sent to the LAR, 
parent, or legal guardian by email or other means for review, prior to the consent interview. 
Informed Consent is considered obtained after the consent interview has occurred, and a signed 
and dated copy of the RESEARCH CONSENT FORM is returned from the LAR, parent, or legal 
guardian to the study coordinator.  
11. Protocol Deviations 
A protocol deviation is any noncompliance with the umbrella trial protocol.  It is the responsibility 
of the investigator to use continuous vigilance to identify deviations and report them within 3 
working days of identification of the protocol deviation, or within 3 working days of the scheduled 
protocol-required activity.  All deviations must be addressed in study source documents.  Protocol 
deviations must be sent to the reviewing Institutional Review Board (IRB) per their policies. The 
study investigator is responsible for knowing and adhering to the reviewing IRB requirements. 
Protocol deviations must also be reported in the study data collection system. 
12. Study Discontinuation and Closure 
This study may be temporarily suspended or prematurely terminated if there is sufficient 
reasonable cause.  Written notification, documenting the reason for study suspension or 
termination, will be provided by suspending or terminating party to study participants, investigator, 
sponsor and regulatory authorities.  If the study is prematurely terminated or suspended, the 
Principal Investigator (PI) will promptly inform study participants, the Institutional Review Board 

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(IRB), and sponsor and will provide the reason(s) for the termination or suspension. Study 
participants will be contacted via phone or email and be informed of changes to study schedule. 
  
Circumstances that may warrant termination or suspension include, but are not limited to: 
● Determination of unexpected, significant, or unacceptable risk to participants 
● Demonstration of efficacy that would warrant stopping   
● Insufficient compliance to protocol requirements 
● Data that are not sufficiently complete and/or evaluable 
● Determination that the primary endpoint has been met 
● Determination of futility 
  
Study may resume once concerns about safety, protocol compliance, and data quality are 
addressed, and satisfy the sponsor, IRB and/or Food and Drug Administration (FDA). 
 
13. Data Management 
13.1. 
Data analysis plan 
Data will be listed and summarized by means of descriptive statistics in tabular and graphical 
formats. Map utilization data will be electronically collected by the MHS and consist  of 
cumulating the numbers of maps accessed by each dyad during the six-month course of the study. 
We still standardize time scales to account for dyads that enrolled and started at different times 
during the study. Specifically, all dyads’ time axes will be rescaled so that Day 1 corresponded to 
the first use-day of the application, regardless of a dyad’s onboarding date. Python Pandas open-
source tool will be utilized for data analyses. GraphPad Prism, v10.2.2, will be used to analyze 
baseline characteristics of care partners and care recipients using descriptive statistics. QOL-18 
uses a Likert scale, and a 1-sample t-test will be used to evaluate the difference of the group mean 
score compared to the null score (3 – no change) of the Likert scale. Analyses of participant 
satisfaction will use descriptive statistics and comparisons of group means will involve unpaired 
comparison t-tests. 
13.2. 
Quality control 
All research personnel will complete CITI training and be knowledgeable about Good Clinical 
Practice (GCP), relevant regulations and policies. The Principal Investigator will ensure adherence 
to the study protocol, regulatory requirements, GCP standards at all times. Additionally, all 
research personnel will complete HIPAA training and receive certification. Team meeting will be 
held on a regular basis to review adherence to study protocol, and to discuss any incidents of 
failures of protocol compliance, keeping adequate and accurate records, and reporting of adverse 

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events. These outcomes of these meetings will be reported to the sponsor and to applicable 
regulatory bodies as requested. 
13.3. 
Data handling 
The final storage space for the study data will be a cloud database and external file storage system.  
The database contains a table with the participant codes ("Participant ID", or "userID") assigned 
to them in the application, and their respective: 
● Screen views: for each screen, time during which the screen was displayed to the user 
● Interactions with all in-app actionable elements (such as buttons) with the element 
identifier and the time of such interaction. 
● Application logs, such as error reports, unexpected shutdowns, etc. 
● Protected health information and clinical outcomes data, if applicable. 
Participant ID (or UserID) will not incorporate personally identifiable information.  
 
All electronic files will be password-protected and stored on a commercial secured and encrypted 
server and will only be accessible to authorized research personnel. All access will be audit logged. 
As data will exist in de-identified form, the electronic data files may be kept indefinitely, if not 
stated otherwise in a subsequent MapHabit sub-study. The Principal Investigator will be 
responsible should receipt and/or transmission of data be required. All data transported/shared will 
be de-identified. 
 
13.4. 
Data Collection 
User interaction data will be collected passively using the Google Firebase Analytics platform 
and will be securely transmitted from the application to the sponsor-maintained cloud database. 
For sub-studies that will be examining clinical outcomes and PHI’s relationship with user 
interaction with the software, data will be transmitted by partnering sites (e.g., Senior Living 
facilities with separate approval) in a secure manner via a cloud-based healthcare database 
platform. For sub-studies that will be examining the effect of virtual reality in MapHabit system 
user engagement, the same standard data collection procedure will take place (i.e., the collection 
of user interaction data via Google Firebase Analytics platform).   
13.5. 
Study Records Retention 
All Protocol Files related to the review and oversight of human subjects’ research protocols 
submitted by the research team to the IRB shall have a cutoff at the end of the fiscal year after the 
research project has been completed or terminated. Records will be retained for 10 years after the 
cutoff.  
 

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Records include, but are not limited to, the application to the IRB; research protocol and 
amendments; case reports forms; Informed Consent template and HIPAA Authorization template; 
reports of adverse events, complaints, and deviations from IRB-approved protocol; data and safety 
monitoring reports; research findings to date; and all relevant documents and related 
correspondences between the IRB and the investigators in the review of an associated protocol.  
 
No records will be destroyed without the written consent of the sponsor, if applicable. It is the 
responsibility of the Study Staff to inform the sponsor when these documents no longer need to be 
retained. 
 
 

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14. Abbreviations 
 
Abbreviation 
Description 
AD 
Alzheimer’s Dementia 
ADL’s 
Activities of Daily Living 
ADRD 
Alzheimer’s Dementia Related Disease 
ADE 
Adverse Events 
CITI 
Collaborative Institutional Training Initiative 
eICF 
Electronic Informed Consent Form 
FDA 
Food and Drug Administration 
GCP 
Good Clinical Practice  
HIPAA 
Health Insurance Portability and Accountability Act of 1996 
ICF 
Informed Consent Form 
IRB 
Institutional Review Board 
MCI 
Mild Cognitive Impairment 
PHI 
Protected Health Information 
PI 
Principal Investigator 
QoL 
Quality of Life 
SAE 
Serious Adverse Event 
TBI 
Traumatic Brain Injury 
UP 
Unanticipated Problem 
 

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15. Statement of Compliance 
The trial will be conducted in accordance with International Conference on Harmonization Good 
Clinical Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations 
(CFR). The Principal Investigator will assure that no deviation from, or changes to the protocol 
will take place without prior agreement from the sponsor and documented approval from the 
Institutional Review Board (IRB), except where necessary to eliminate an immediate hazard(s) to 
the trial participants. 
  
The protocol, Informed Consent form(s), recruitment materials, and all participant materials will 
be submitted to the IRB for review and approval.  Approval of both the protocol and the consent 
form must be obtained before any participant is enrolled.  Any amendment to the protocol will 
require review and approval by the IRB before the changes are implemented to the study.  All 
changes to the consent form will be IRB approved; a determination will be made regarding whether 
a new consent needs to be obtained from participants who provided consent, using a previously 
approved consent form. 
 

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16. Potential Sub-Study Surveys & Questionnaires 
16.1. 
 Quality of Life in Alzheimer’s Disease 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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16.2. 
The Zarit Burden Interview 

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16.3. 
The Pittsburgh Sleep Quality Index (PSQI) 
 
 
 
 
 
 
 
 
 
 
 

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16.4. 
 The Lawton Instrumental Activities of Daily Living Scale  
 
 
 
 
 
 
 
 

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16.5. 
The Neuropsychiatric Inventory Questionnaire  
 
 

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16.6. 
The Montreal Cognitive Assessment (MOCA) 
Sample, can be administered and scored virtually: 

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16.7. 
Live Alone Assessment Adapted from the University of Iowa 
 
 

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16.8. 
Medication Management Instrument for Deficiencies in the 
Elderly (MedMaIDETM) 
 
 
 

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16.9. 
Geriatric Depression Scale  
 
 
 
 
 
 
 
 
 
 
 
 

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16.10. 
Pain Assessment in Advanced Dementia Scale (PAINAD) 
 
 
 
 
 
 
 
 

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16.11. 
Caregiver Self-Assessment Questionnaire  
 
 
 
 
 

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16.12. 
LuMind Down Syndrome Caregiver Assessment  
 
Caregiver Survey on Independence in Down Syndrome  
1. Contact Information 
a. Name: ____________ 
b. Company: ____________ 
c. Address: ____________ 
d. Address 2: ____________ 
e. City/Town: ____________ 
f. 
State Province (If in the United States): ____________ 
g. ZIP/Postal Code: ____________ 
h. Country: ____________ 
i. 
Email Address: ____________ 
j. 
Phone Number: ____________ 
2. Who is completing this survey? Please select all options below that best describes your 
relationship to the loved on with Down Syndrome 
a. Parent 
b. Sibling  
c. Other Caregiver 
d. Other (Please specify) 
3. Your age? 
a. Under 18 
b. 18-24 
c. 25-34 
d. 35-44 
e. 45-54 

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f. 
55-64 
g. 65+ 
4. Highest Education Level 
a. Elementary School 
b. Middle School 
c. High School Graduate 
d. College Graduate  
e. Post-Graduate Degree 
5. What country do you live in? 
a. ____________ 
6. In which town or city do you live in? 
a. ____________ 
7. If in the U.S., which U.S. state do you live in? 
a. ____________ 
8. What is your zip code (if you live in the U.S.) or postal code (if you live outside the U.S.)?  
a. ____________ 
9. What is your approximate average household income?  
a. Under $49,999 (Under R44,730) 
b. Between $50,000 and $99,999 (Between €44,731 - 89,463) 
c. Between $100,000 and $149,999 (Between €89,464 - 134,195) 
d. Between $150,000 and $199,999 (Between €134,196 - 178,927) 
e. Over $200,000 (Over 178,928) 
f. 
Prefer not to answer. 
10. What was the date of birth of the loved one with Down Syndrome? 
a. ____________ 
11. Does the loved one with Down syndrome live in the location listed previously? 

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a. Yes 
b. No 
12. What country does the loved one with Down syndrome live in? 
a. ____________ 
13. In which town or city does the loved one with Down syndrome live in? 
a. ____________ 
14. If in the US, which state does the person with Down syndrome live in? 
a. ____________ 
15. What is the loved one with Down syndrome zip code (if they live in the United States) or 
postal code (if they live outside the US?) 
a. ____________ 
16. Does the loved one with Down syndrome live: 
a. Independently  
b. In a group home 
c. With family  
d. Other (please specify) ____________ 
17. Which race/ethnicity best describes the loved one with Down Syndrome? (Please 
choose) 
a. White or Caucasian 
b. Black or African American 
c. Hispanic or Latinx 
d. Asian or Asian American 
e. Native American or Alaska Native 
f. 
Native Hawaiian or other Pacific Islander 
g. Another race 
18. What is the loved one with Down syndrome's gender? 

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a. Female 
b. Male  
c. Non-Binary 
d. Other  
19. My loved one with Down syndrome has an additional diagnosis, which has been 
confirmed by a medical professional, (choose all that apply) of: 
a. Attention Deficit Hyperactivity Disorder (ADHD) 
b. Autism or autism spectrum disorder (ASD) 
c. Regression 
d. Sleep Apnea 
e. Celiac Disease 
f. 
Obsessive Compulsive Disorder (OCD) 
g. Mental Health diagnosis 
h. Dementia or Alzheimer's Disease 
i. 
Crohn's Disease 
j. 
Moya Moya 
k. Obesity 
l. 
Medically Complex 
m. Mobility (Please describe below) 
i. ____________ 
n. None of the above 
o. Other diagnosis that you think affects the loved one with Down syndrome's 
(Please specify)  
i. ___________ 
20. I feel the following SAFETY topics are important for my loved one with Down syndrome 
(Check all that apply): 

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a. Social media safety 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
b. Internet safety 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
c. Bullying 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
d. Sexual Abuse 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
e. Verbal Abuse 
i. Achieved already 

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ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
f. 
Stranger Danger 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
g. Safely crossing a street/parking lot 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
h. Bolting/Elopement (running away from caregiver) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
i. 
Kitchen/cooking safety 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 

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iv. Not achieved but may be important to me in the future 
v. Don’t know 
j. 
Water safety 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
k. Staying with a babysitter or other caregiver 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
l. 
Left home alone for greater than 2 hours 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
m. Go out alone 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 

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n. Other (please explain): _____________ 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
21. Top 3 choices for SAFETY from question 20 
a. 1st Choice: ________ 
b. 2nd Choice:________ 
c. 3rd Choice:________ 
22. I feel the following SELF-CARE topics are important for my loved one with Down 
syndrome: 
a. Dress and undress self 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
b. Putting on/tying shoes 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
c. Use toilet independently 
i. Achieved already 

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ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
d. Grooming, brushing teeth, combing and/or brushing hair 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
e. Wash himself/herself (shower or bath) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
f. 
Shaving 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
g. Cutting fingernails and toenails 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 

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iv. Not achieved but may be important to me in the future 
v. Don’t know 
h. Female hygiene needs 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
i. 
Healthy eating/portion control 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
j. 
Take own medications 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
k. Self-reporting feelings and health 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 

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l. 
Understanding of puberty 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
m. Healthy understanding of sexuality 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
n. Someone "safe" to talk to about thoughts and feelings 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
o. Other (please explain) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
23. Top 3 choices for SELF-CARE from question 22: 
a. 1st Choice: ________ 

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b. 2nd Choice: ________ 
c. 3rd Choice: ________ 
24. I feel the following DAILY LIVING topics are important for my loved one with Down 
syndrome: 
a. Drink independently from a cup 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
b. Eat meals independently 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
c. Move around in or out of the house 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
d. Navigating public transportation alone 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 

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iv. Not achieved but may be important to me in the future 
v. Don’t know 
e. Traveling alone (on planes, trains, etc.) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
f. 
Living independently/semi-independently 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know  
g. Driving 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know  
h. Doing errands, including shopping in stores 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 

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i. 
Use money 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
j. 
Manage daily finances (keep track of cash, checking account, pay bills, etc.) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
k. Carry out domestic activities (make bed, pick up around the house, light 
housecleaning, etc.) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
l. 
Doing laundry, washing and drying 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
m. Use a watch 

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i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
n. Follow a schedule 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
o. Time Management 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
p. Prepare simple meals (requiring no mixing or cooking, including sandwiches, 
cold cereal, etc.) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
q. Cook meals (fry eggs, make pancakes, etc.) 
i. Achieved already 

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ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
r. Weight Management 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
s. Other (please explain) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
25. Top 3 choices for DAILY LIVING from question 24: 
a. 1st Choice: ________ 
b. 2nd Choice: ________ 
c. 3rd Choice: ________ 
26. I feel the following SOCIAL/LEISURE TIME topics are important for my loved one with 
Down syndrome: 
a. Engages in leisure time appropriately 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 

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iv. Not achieved but may be important to me in the future 
v. Don’t know 
b. Able to manage disruptions to routines or schedules 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
c. Watching TV 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
d. Listening to music 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
e. Volunteering 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 

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f. 
Playing games (card games) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
g. Participate in hobbies (painting, gardening, writing, dancing, etc.) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
h. Sports activities 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
i. 
Walking 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
j. 
Hanging out with friends 
i. Achieved already 

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ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
k. Going out to eat 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
l. 
Religious activities (church, etc.) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
m. Going to the movies 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
n. Other (please explain) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 

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iv. Not achieved but may be important to me in the future 
v. Don’t know 
27. Top 3 choices for SOCIAL/LEISURE TIME from question 26: 
a. 1st Choice: ________ 
b. 2nd Choice: ________ 
c. 3rd Choice: ________ 
28. I feel the following VOCATIONAL/EMPLOYMENT topics are important for my loved one 
with Down syndrome: 
a. Reading and writing 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
b. Driving 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
c. Navigating public transportation alone 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 

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d. Traveling alone (on planes, trains, etc.) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
e. Time management 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
f. 
Interpersonal skills 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
g. Money management 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
h. Ability to ask for help when needed 
i. Achieved already 

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ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
i. 
Respecting personal boundaries 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
j. 
Appropriate behavior 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
k. Ability to focus on task at hand 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
l. 
Organization skills 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 

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iv. Not achieved but may be important to me in the future 
v. Don’t know 
m. Understand what he/she reads 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
n. Use verbal communication 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
o. Be understood by others, even with limited language 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
p. Use telephone 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 

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q. Use a computer for internet and e-mail 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
r. Other (please explain) 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
29. Top 3 choices for VOCATIONAL/EMPLOYMENT from question 28: 
a. 1st Choice: ________ 
b. 2nd Choice: ________ 
c. 3rd Choice: ________ 
30. I feel the following COMMUNICATION TOPICS are important for my loved one with 
Down syndrome: 
a. Communicating wants and needs 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
b. Browse picture books without reading 
i. Achieved already 

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ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
c. Write his/her own name 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
d. Understand what he/she writes 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
e. Comprehend reading aloud 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
f. 
Write to communicate 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 

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iv. Not achieved but may be important to me in the future 
v. Don’t know 
g. Read for pleasure 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
h. Understand what he/she reads 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
i. 
Use verbal communication 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
j. 
Be understood by others, even with limited language 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 

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k. Use telephone 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
l. 
Use computer to play 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
m. Use a computer for internet and e-mail 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
n. Sharing personal information appropriately 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
o. Getting to/Making/Asking questions at doctor appointments 
i. Achieved already 

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ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
p. Ability to consent to medical treatment 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
q. Able to verbalize, sign or use assistive communication device to express wants 
and needs 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
r. Expresses emotions appropriately 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
s. Ability to participate in a conversation (verbal, sign language or via a 
communication devise) 
i. Achieved already 

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ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
t. 
Other (please explain): _______________ 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
31. Top 3 choices for VOCATIONAL/EMPLOYMENT from question 30: 
a. 1st Choice: ________ 
b. 2nd Choice: ________ 
c. 3rd Choice: ________ 
32. Which statement below best describes your wishes as a CAREGIVER for your loved 
one with Down syndrome? 
a. Be as independent as possible 
b. Achieve some independence  
c. Independence is not a priority  
33. The following CAREGIVER self-care topics are important to me as the caregiver of a 
loved one with Down syndrome in terms of MY independence. This question is about 
YOUR ability as a caregiver to be independent of your loved one with Down syndrome. 
a. Run errands with loved one safely at home 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 

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iv. Not achieved but may be important to me in the future 
v. Don’t know 
b. Run errands with loved one safely at my side 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
c. Vacations 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
d. Respite care 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
e. Financial planning 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 

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f. 
Ability to care for self 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
g. Ability to call for emergency at appropriate times 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
h. Ability to know how to get help 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
i. 
Understanding entitlement programs such as Medicaid and Social Security 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
j. 
What will happen after I am gone 
i. Achieved already 

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ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
k. Burden of multiple medical appointments 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
l. 
Reduce stress of the planning for my loved one with DS’s options after age 22 
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
m. Other (please explain)  
i. Achieved already 
ii. Not achieved but not important 
iii. No achieved but important to me now 
iv. Not achieved but may be important to me in the future 
v. Don’t know 
34. Top 3 choices for CAREGIVER self-care from question 33: 
a. 1st Choice: ________ 
b. 2nd Choice: ________ 
c. 3rd Choice: ________ 

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35. Do you have ideas on further research into practical solutions for supporting greater 
independence? 
a. No 
b. Yes (please explain) ___________________ 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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16.13. 
Vineland-3 Adaptive Behavior Scales 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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16.14. 
Behavior Problems Inventory 
 

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16.15. 
MapHabit, Inc. Final Exit Interview Questionnaire  
Date: ___________________                                  Name or ID: __________________________ 
 
Compared to three months ago, before you and ___(name)___ started using the MapHabit 
System: 
o Are you now experiencing: 
o Is ___(name)___ now experiencing: 
 
Please use the scale indicated 
 
1 = Much negative change 2 = Some negative change    3 = No change    4 = Some positive change     5 = Much positive change  
 
1. Improved mood 
2. Improved independence 
3. Improved ability to carry out some ADL 
4. Completes ADLs more quickly 
5. Needs less reminding during an ADL 
6. Improved social interaction 
7. Less depression 
8. Less anxiety 
9. Less frustration 
10. Less anger 
11. Better coping ability 
12. Improved memory for some things 
13. More social engagement 
14. An overall better quality of life 
15. More enjoyment of life 
16. More better moments 
17. Expresses appreciation more 
18. More cooperative 
 
19. How satisfied are you with your progress in this program? 
 
3 = Completely.       2 = Somewhat.         3 = Not at all 
 
20. Overall, do you feel you are: 
 
5 = Much better. 4 = Better.  3 = About the same.   2 = Worse.    1 = Much worse 
 
21. Would you recommend the MHS to your colleagues?     2 = Yes.    1 = No 

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16.16 Wisconsin Quality of Life Index (W-QLI) 

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16.17 Pain and Sleep Questionnaire (PSQ-3)  
 

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16.18 Patient Health Questionnaire (PHQ9) 
16.19 
Generalized Anxiety Disorder Scale (GAD7)  

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16.20 Anger Management Scale 

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16.21 Caregiver Self-Assessment Questionnaire 

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16.22 Bristol Activities of Daily Living Scale (BADLs) 

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16.23 Net Promoter Scale Questionnaire 
17. Assent Form 
17.1. 
Assent Form for Minors with Down Syndrome 
 

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This handout is about the MapHabit Down Syndrome Study. The MapHabit System 
features an app for your smart phone device or tablet that seeks to help you learn 
and gain independence. 
 
We are asking that you join our study because we want to learn more about the 
health of children with Down Syndrome  
 
You will be a part of a study that includes other children with Down Syndrome at 
different locations across the United States! 
 
 
A group of professionals called an IRB reviewed this study for us. Their job is to 
assure that this study is safe and that participants like you are protected. 

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You will be using the MapHabit System and application for 6 months. You may have 
a few visits to a study site OR a virtual study meeting during the time you are in 
the study. You will come with your study partner. Your study partner will be a 
parent, other family member, or caregiver! 
 
 
 
Your study partner will complete a set of questionnaires on your behalf at the 
start and at the end of the study. You are only expected to use the MapHabit 
System daily with the supervision of your study partner. 
 

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If you have any questions, you and your study partner may ask a member of the 
study team! 
 
 
 
 
 
 
This study is private. Only your study partner and the study team will know that 
you are participating in this study. Your personal information (name, address, 
pictures, audio, or video) will not be shared beyond your designated study partner 
and the study team. 
 
 
 
 
 
 
 
 
We anticipate that using the MapHabit System will be a positive and fun learning 
opportunity however—you do not have to be in this study if you do not want to and 
there are no consequences if you choose not to participate. You will always have the 
right to stop at any time. 
 
 
 
 
 
 
 

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Thank you for learning about the study and we hope that you join us! If you have 
any questions, you and your study partner may ask the study coordinator or a 
member of the study team! 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
18. References 
[1] Jack CR Jr, Petersen RC, Xu Y, O'Brien PC, Smith GE, Ivnik RJ, Tangalos EG, Kokmen E. 
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