Towards the Development of a Mobile-health Technology Designed to Encourage the Use of Serious Game-based Interventions in Patients With Mild Cognitive Impairment Outside the Clinic
Phase: NA
Conditions: Mild Cognitive Impairment
Sponsor: University of Massachusetts, Amherst

​Official Study Title:​
​Towards​​the​​development​​of​​a​​mobile-health​​technology​​designed​​to​​encourage​​the​​use​
​of​​serious​​game-based​​interventions​​in​​patients​​with​​mild​​cognitive​​impairment​​outside​
​the clinic​
​NCT Number:​
​NCT04920123​
​Document Type:​
​Study Protocol​
​Document Date​:​
​February 05, 2025​

​STUDY PROTOCOL​
​Study Procedures​:​
​1.​ ​Recruitment​
​2.​ ​Screening​
​3.​ ​Informed consent obtainment​
​4.​ ​Random assignment into two groups​
​5.​ ​Assessment at baseline​
​6.​ ​Shipping​​tablet​​PC​5.​​Assessment​​at​​baseline​​(Only​​Rutgers​​RA​​can​​perform​​assessment;​​UMass​
​RAs will organize the overall meeting)​
​7.​ ​Tutorial for the intervention group​
​8.​ ​Checking compliance every week (twice per week)​
​9.​ ​Assessment after 12 weeks​
​10.​​Returning tablet PC​
​11.​ ​Focus group (Online workshop)​
​12.​​Assessment after 24 weeks​
​Role Assignment​
​UMass RA​
​Rutgers RA​
​Recruitment​
​O​
​O​
​Screening​
​O​
​O​
​Informed consent obtainment​
​O​
​O​
​Random assignment into two groups​
​O​
​X​
​Assessment at baseline​
​O (general instructions​
​before assessment)​
​O (actual assessment)​
​Shipping tablet PC​
​O​
​X​
​Tutorial for the intervention group​
​O​
​X​
​Checking compliance every week​
​O​
​X​
​Assessment after 12 weeks​
​O (general instructions​
​before assessment)​
​O (actual assessment)​
​Returning table PC​
​O​
​X​
​Focus group (Online workshop)​
​O​
​X​
​Assessment after 24 weeks​
​O (general instructions​
​before assessment)​
​O (actual assessment)​

​1. Recruitment​:​
​- 50​​participants with Mild Cognitive Impairment (MCI)​​will be recruited as follows.​
​●​ ​Currently planned means:​
​o​ ​Emailing​ ​recruitment​ ​flyers​ ​to​ ​residents​ ​in​ ​local​ ​senior​ ​centers​ ​in​ ​Amherst,​ ​MA​ ​and​
​Union, NJ​
​o​ ​Emailing recruitment flyers to support groups and conferences​
​o​ ​Posting​​recruitment​​flyers​​on​​the​​Internet​​(e.g.,​​ClinicalTrials.gov​,​​National​​Alliance​​on​
​Mental Illness; nami.org, Alzheimer’s Association; alz.org, UMass newsletter)​
​o​ ​Posting​​an​​abbreviated​​recruiting​​message​​+​​screen​​shots​​of​​flyers​​on​​the​​social​​media​
​(e.g., Facebook, Twitter)​
​▪​
​Recruiting​​message:​​“​If​​you​​believe​​you​​have​​mild​​cognitive​​impairment,​​and​​are​
​interested​​in​​cognitive​​training​​using​​mobile​​games,​​please​​contact​​AHHA​​Lab​
​(413-545-8875,​​umass.ahha.lab@gmail.com​).”​
​o​ ​Visit senior villages​
​●​ ​Optional means:​
​o​ ​Using paid third-party services that perform the recruiting process​
​o​ ​Advertising on local newspapers​
​- The flyer can be found in​​Appendix 1​. (unified phone​​number / email address)​
​- Available recruitment methods (website, social media group) are listed in the spreadsheet​
​(​Patient Recruitment/Contact Information.xlsx​)​

​2. Screening​​(Both UMass & Rutgers RA can perform)​
​- When a volunteer contacts us through AHHA lab’s email or phone number, their​​name,​​phone number,​
​and​​email​​will be collected using email reply (email)​​or pre-recorded voicemail instruction (phone).​
​●​ ​UMass and Rutgers RAs will check the email and the voicemail box regularly (1 time a week by​
​each RA). The following is an example.​
​○​ ​Rutgers RA: Mon​
​○​ ​UMass RA1: Wed​
​○​ ​UMass RA2: Fri​
​●​ ​RAs will​​add a new record​​in the RedCap and enter​ ​the volunteer’s​​name​​in the​​Name Data​
​instrument,​​and​​phone number​​and​​email​​in the​​MCI​​Participant Demographics instrument​
​of the RedCap and remove processed voicemail messages.​
​○​ ​The convention for naming the study ID for a person with MCI will be, for example,​
​MCI21 (password for Neuro-World administration is woorisoft!@)​
​●​ ​The​ ​prefix​ ​MCI​ ​followed​ ​by​ ​an​ ​incrementing​ ​number​ ​with​ ​0​ ​padding​ ​for​ ​a​
​single-digit​​number​​(e.g.,​​MCI02​​will​​be​​assigned​​after​​MCI01​;​​MCI22​​will​​be​
​assigned after​​MCI21​).​
​●​ ​The​ ​study​ ​ID​ ​will​ ​be​ ​used​ ​for​ ​a​ ​MCI​ ​participant.​ ​In​ ​other​ ​words,​ ​an​ ​active​
​caregiver will not be given a separate study ID.​
​●​ ​If a caregiver participates in the study, RAs will enter the caregiver’s​​name​​in the​​Name Data​
​instrument,​​and​​phone number​​and​​email​​in the​​Caregiver​​Demographics instrument​​of the​
​RedCap and remove processed voicemail messages.​
​○​ ​The caregiver for the person with MCI will be given a separate study ID, for example​
​CARE21​.​
​■​ ​The prefix CARE followed by an incrementing number that matches that of the​
​person with MCI. (record in the​​Caregiver Demographics​​instrument​)​
​- Any of the 3 RAs will call the volunteer, if the corresponding​​Screening Data instrument​​is not​
​completed (i.e., not green), using the phone number in the​​MCI Participant Demographics instrument​.​
​●​ ​If the​​volunteer​​have approximately 30 minutes at​​the time of zoom call,​
​○​ ​Each volunteer is asked for their demographic information, including gender, age, etc.,​
​which will be entered in​​the MCI Participant Demographics​​instrument​.​
​○​ ​If a caregiver participates in the study, each caregiver is asked for their demographic​
​information, including gender, age, etc., which will be entered in​​the Caregiver​
​Demographics instrument​.​

​○​ ​Each volunteer is asked​​inclusion and exclusion questions​​(See​​Appendix 2​​for the​
​inclusion & exclusion questions), answers of which will be entered in​​the Screening​
​Data instrument​.​
​○​ ​The volunteer’s caregiver will be asked​​inclusion​​and exclusion questions, the answers​
​of which will be entered in the Screening Data instrument​.​​The fields are popped up​
​when selecting ‘Yes’ to the questions ‘Is a caregiver available to participate in this​
​study’?​
​○​ ​The volunteer, meeting the inclusion and exclusion questions, will be assessed for his/her​
​cognitive function using the​​MoCA test via Zoom​. The​​answers will be entered in​​the​
​Screening Data instrument​.​
​■​ ​The volunteer, scoring MoCA​​17 <= (score) < 26​, will​​be included in our study.​
​○​ ​If both the volunteer and the active caregiver are eligible to join the study,​
​■​ ​The RA will ask the​​volunteer​​and his/her active​​caregiver​​for their contact​
​information, including their name, email address, and phone number if not​
​collected yet, which will be entered in​​the MCI Participant/Caregiver​
​Demographics instrument​.​
​■​ ​The RA will inform the volunteer and the active caregiver that the informed​
​consent documents will be sent to them via email, and ask them to read, sign, and​
​return the signed informed consent form.​
​■​ ​The RA will change​​the Form Status (Complete) field​​of​​the Screening Data​
​to Complete (i.e., green color). Green color indicates that the volunteer and the​
​active caregiver are eligible for our study.​
​○​ ​If either the volunteer or the active caregiver or none of them is/are eligible to join the​
​study,​
​■​ ​All the contact information (name, email, phone number) will be removed from​
​the MCI Participant/Caregiver Demographics instrument​.​
​■​ ​The demographic information and the answers to the inclusion/exclusion​
​question will be stored.​
​■​ ​The RA will change​​the Form Status (Complete) field​​of​​the Screening Data​
​to Incomplete (i.e., red color). Red color indicates that the volunteer and the​
​active caregiver are not eligible for our study.​
​●​ ​If the​​volunteer​​or his/her have active​​caregiver​​do not have time at the moment,​
​○​ ​The RA will schedule an appointment for a phone screening and enter the date and notes​
​in​​the Contact Attempt field​​of​​the Screening Data​​instrument​.​
​○​ ​The RA leaves​​the Form Status field​​of​​the Screening​​Data instrument​​to Incomplete.​
​●​ ​If the volunteer cannot be reached,​
​○​ ​The RA will leave a message.​
​■​ ​Message:​​“Hello. This is – from the UMass Amherst​​research team. I am​
​contacting you about your interest in participating in our research about mild​
​cognitive impairment. I’d like to discuss your eligibility to participate in our​
​research. I would be grateful if you could call back us when you are available.​
​My number is -----. Thank you.”​
​○​ ​The RA will enter the attempted date, time, and responses in​​the Contact Attempt 1/2/3​
​for MCI Participant​​or​​Caregiver​ ​in the​​Screening​​Data instrument​.​
​○​ ​If the RA completes the screening, enter the completed date, time, and their name in the​
​Screening Data instrument​.​
​○​ ​If all the Contact Attempt 1/2/3 are entered, the RA will change​​the Form Status​
​(Complete) field​​of​​the Screened Result instrument​​to Incomplete (i.e., red color).​
​- For those who are eligible to participate in the study (called​​participants​​hereafter), see the​​3.​​Informed​
​consent obtainment​​and​​5. Assessment at baseline​​within​​the phone call​.​

​3. Informed consent obtainment​​(Both UMass can perform)​
​- (When the RA, volunteer, and the active caregiver remain on the phone after the screening process) An​
​RA will email informed consent forms either to 1) the volunteer and the active caregiver to their email​
​addresses separately or 2) the active caregiver depending on the participants’ preference.​
​●​ ​UMass and Rutgers RAs will email at the end of the​​2. Screening​​when both the volunteer and​
​the active caregiver are determined eligible for our study.​
​●​ ​Use DocuSign @​​DocuSign Login - Enter email to start​​sign in​.​
​●​ ​If both the volunteer and the active caregiver have time,​
​○​ ​The RA will give the volunteer and the active caregiver to read the informed consent​
​form.​
​○​ ​The RA will answer questions should the volunteer and the active caregiver have any.​
​○​ ​When the volunteer and the active caregiver sign (using​​DocuSign​) and return the signed​
​informed consent form,​
​■​ ​The RA will enter the date the forms are received.​
​■​ ​The RA will change​​the Form Status field​​of​​the Informed​​Consent​
​instrument​​to Complete.​
​■​ ​The signed informed consent will be stored in the UMass-supported cloud (i.e.,​
​OneDrive).​
​■​ ​The​​RA​​will​​schedule​​an​​assessment​​with​​the​​volunteer​​and​​the​​active​​caregiver​
​for​​the​​baseline​​assessment​​when​​one​​UMass​​RA,​​the​​Rutgers​​RA,​​the​​volunteer,​
​and the active caregiver are available for 2 hours in a row​
​(AHHA lab account,​​umass.ahha.lab@gmail.com​)​.​
​■​ ​The RA will mark the scheduled assessment on the Google calendar.​
​●​ ​If the volunteer or the active caregiver do not have time,​
​○​ ​The RA will schedule an appointment when any of the RAs are available based on the​
​Google calendar (AHHA lab account,​​umass.ahha.lab@gmail.com​)​.​
​○​ ​The RA will inform other RAs of the scheduled appointment in the Slack channel.​
​- (When an RA is making a separate call) An RA, who is available at the scheduled appointment time,​
​will call the volunteer, assuming that the active caregiver accompanies the volunteer.​
​●​ ​The RA will give the volunteer and the active caregiver time to read the informed consent form.​

​●​ ​The RA will answer questions should the volunteer or the active caregiver have any.​
​●​ ​When the volunteer and the active caregiver sign and return the signed informed consent form,​
​○​ ​The RA will enter the date the forms are received.​
​○​ ​The RA will change​​the Form Status field​​of​​the Informed​​Consent instrument​​to​
​Complete.​
​○​ ​The signed informed consent will be stored in the UMass-supported cloud (i.e.,​
​OneDrive).​
​○​ ​The​ ​RA​ ​will​ ​schedule​ ​an​ ​assessment​ ​with​ ​the​ ​volunteer​ ​(optionally,​ ​and​ ​the​ ​active​
​caregiver)​ ​for​ ​the​ ​baseline​ ​assessment​ ​when​ ​one​ ​UMass​ ​RA,​ ​the​ ​Rutgers​ ​RA,​ ​the​
​volunteer, and the active caregiver are available for 2 hours in a row​
​(AHHA lab account,​​umass.ahha.lab@gmail.com​)​.​
​○​ ​The RA will mark the scheduled assessment on the Google calendar.​

​4. Random assignment into two groups​​(Only UMass RA​​can perform)​
​-​​When​​the​​UMass​​RA​​finds​​a​​study​​ID​​with​​the​​completed​​Informed​​Consent​​instrument​​(i.e.,​​green​
​color),​ ​the​ ​RA​ ​refers​ ​to​ ​random_group_assign.xlsx​ ​(in​ ​the​ ​Google​ ​folder​ ​Pre-determined​
​randomization,​​which​​is​​only​​available​​to​​the​​UMass​​RAs​)​​and​​assigns​​the​​study​​ID​​to​​either​​Group​​A​
​or B.​
​●​ ​Group A​
​○​ ​First period: Neuro-World game intervention (12 weeks)​
​○​ ​Second period: phone interaction + usual care (12 weeks)​
​●​ ​Group B​
​○​ ​First period: phone interaction + usual care (12 weeks)​
​○​ ​Second period: Neuro-World game intervention (12 weeks)​
​-​​The Randomization instrument​​will be hidden from​​the Rutgers personnel throughout the study.​

​5.​ ​Assessment​ ​at​ ​baseline​ ​(Only​ ​Rutgers​ ​RA​ ​can​ ​perform​​assessment;​
​UMass RAs will organize the overall meeting)​
​- A UMass RA will remind the participant of the scheduled assessment.​
​●​ ​Give​​a​​call​​to​​the​​participant,​​remind​​them​​1​​day​​before​​the​​scheduled​​assessment​​in​​the​​following​
​order.​
​○​ ​Phone call​
​○​ ​If not answering, text and email.​
​●​ ​Give a call to the participant, remind them 2 hours before the scheduled assessment.​
​○​ ​Phone call​
​○​ ​If not answering, text and email.​
​- A UMass RA will organize the zoom meeting.​
​●​ ​The UMass RA will initiate a zoom meeting.​
​●​ ​A​​UMass​​RA​​will​​email​​a​​zoom​​link​​to​​the​​participant’s​​email​​and​​the​​Rutgers​​RA​​approximately​
​10 minutes before the scheduled time.​
​●​ ​The Rutgers RA will join the meeting.​
​●​ ​Introduce RAs​
​○​ ​Message:​ ​“​Hello,​​[Participant​​name].​​I​​am​​[Umass​​RA​​name],​​and​​a​​researcher​​from​
​UMass​​Amherst.​​Today,​​we​​will​​administer​​cognitive​​assessments​​and​​some​​surveys​​to​
​you​​and​​your​​helper.​​They​​will​​take​​about​​2​​hours​​to​​complete.​​All​​the​​assessments​​will​​be​
​administered​​by​​[Rutgers​​RA].​​Can​​you​​introduce​​yourself​​briefly,​​[Rutgers​​RA]?​​Before​
​starting​ ​assessments,​ ​I​ ​will​ ​break​ ​a​ ​room​ ​for​ ​[Rutgers​ ​RA]​ ​to​ ​give​ ​some​ ​important​
​instructions for today's session.​
​●​ ​The​​UMass​​RA​​will​​break​​out​​a​​meeting​​room​​for​​the​​Rutgers​​RA,​​and​​the​​Rutgers​​RA​​will​​wait​
​in the room.​
​●​ ​The volunteer will join the meeting at the scheduled time.​
​●​ ​The UMass RA will explain about the assessment.​
​○​ ​Message:​
​○​ ​Group​​A:​​“OK.​​I​​will​​give​​the​​overall​​process​​of​​our​​study​​first.​​Our​​study​​participants​
​are​​divided​​randomly​​into​​Group​​A/B.​​You​​are​​selected​​as​​Group​​A.​​It​​means​​that​​for​​the​
​first​​12​​weeks,​​you​​play​​a​​cognitive​​game​​with​​the​​provided​​tablet​​PC.​​We​​will​​also​​follow​
​up​​on​​your​​game​​playing​​experience​​and​​your​​cognitive​​and​​physical​​activity​​by​​call​​and​
​email​​survey.​​They​​will​​be​​very​​brief​​and​​take​​about​​1​​min.​​After​​12​​weeks,​​you​​need​​to​
​return​​a​​table​​PC,​​and​​do​​the​​second​​assessment,​​and​​don’t​​need​​to​​do​​anything​​particular​
​for​​the​​next​​12​​weeks.​​We​​will​​just​​check​​your​​cognitive​​and​​physical​​activity.​​For​​this​
​assessment,​​an​​important​​note​​is​​that​​[​Rutgers​​RA]​]​​should​​not​​know​​about​​which​​group​
​you​​are​​in.​​Please​​know​​that​​[Rutgers​​RA]]​​is​​only​​here​​for​​the​​assessment​​purpose.​​To​
​assess​ ​your​ ​cognitive​​function​​without​​any​​bias,​​[Rutgers​​RA]​​should​​not​​know​​which​
​group​​you​​are​​in,​​you​​already​​received​​a​​table​​PC,​​and​​start​​to​​play​​a​​game​​soon.​​So,​​if​
​you​​have​​any​​concerns​​or​​questions​​related​​to​​our​​overall​​study​​procedure,​​game​​play​​or​
​tablet​​PC,​​please​​feel​​free​​to​​talk​​to​​me​​or​​ask​​me.​​{(optional)​​For​​today's​​assessment,​
​[Helper​ ​Name]​ ​will​ ​be​ ​asked​ ​survey​ ​questions​ ​related​ ​to​ ​[participant​ ​name]’s​ ​daily​
​activity​ ​first​ ​before​ ​starting​ ​cognitive​ ​assessment.​ ​I​ ​will​ ​break​ ​a​ ​zoom​ ​room​ ​for​
​[participant​ ​name]​ ​during​ ​the​ ​survey,​ ​and​ ​let​ ​[participant​ ​name]​ ​join​ ​again​ ​after​
​completing​ ​the​ ​survey.​ ​[participant​ ​name],​ ​do​ ​you​​feel​​comfortable​​with​​using​​zoom?​
​After​​completing​​the​​survey,​ ​[helper​​name]​​please​​stay​​in​​the​​house​​but​​not​​in​​the​​room​
​during​ ​the​ ​assessments.}​ ​The​ ​entire​ ​assessment​ ​will​ ​be​ ​video-recorded​ ​for​ ​future​
​reference.​​Now​​the​​[Rutgers​​RA]​​will​​join​​and​​start​​the​​assessment.​​I​​will​​stay​​muted​​until​
​the assessment is over, but if you have a question, please feel free to ask me.​”​

​○​ ​Group​​B:​​“OK.​​I​​will​​give​​the​​overall​​process​​of​​our​​study​​first.​​Our​​study​​participants​
​are​​divided​​randomly​​into​​Group​​A/B.​​You​​are​​selected​​as​​Group​​B.​​It​​means​​that​​For​​the​
​first​​12​​weeks,​​you​​don’t​​need​​to​​do​​anything​​for​​this​​study​​but​​we​​will​​just​​check​​you​
​about​​your​​cognitive​​and​​physical​​activity​​such​​as​​puzzles,​​board​​games​​or​​hiking​​like​
​that.​​After​​12​​weeks,​​you​​will​​receive​​a​​table​​PC​​and​​play​​a​​cognitive​​training​​game.​​For​
​this​​assessment,​​an​​important​​note​​is​​that​​Aurora​​should​​not​​know​​about​​which​​group​​you​
​are​​in.​​Please​​know​​that​​[name3]​​is​​only​​here​​for​​the​​assessment​​purpose.​​To​​assess​​your​
​cognitive​​function​​without​​any​​bias,​​[Rutgers​​RA]​​should​​not​​know​​that​​you​​are​​starting​
​12​​weeks​​with​​no​​game​​play​​and​​you​​will​​receive​​a​​table​​PC​​12​​weeks​​later.​​So,​​if​​you​
​have​ ​any​ ​concerns​ ​or​ ​questions​ ​related​ ​to​​our​​overall​​study​​procedure,​​game​​play​​or​
​tablet​​PC,​​please​​feel​​free​​to​​talk​​to​​me​​or​​ask​​me.​​{(optional)​​For​​today's​​assessment,​
​[Helper​ ​Name]​ ​will​ ​be​ ​asked​ ​survey​ ​questions​ ​related​ ​to​ ​[participant​ ​name]’s​ ​daily​
​activity​ ​first​ ​before​ ​starting​ ​cognitive​ ​assessment.​ ​I​ ​will​ ​break​ ​a​ ​zoom​ ​room​ ​for​
​[participant​ ​name]​ ​during​ ​the​ ​survey,​ ​and​ ​let​ ​[participant​ ​name]​ ​join​ ​again​ ​after​
​completing​ ​the​ ​survey.​ ​[participant​ ​name],​ ​do​ ​you​​feel​​comfortable​​with​​using​​zoom?​
​After​​completing​​the​​survey,​ ​[helper​​name]​​please​​stay​​in​​the​​house​​but​​not​​in​​the​​room​
​during​ ​the​ ​assessments.}​ ​The​ ​entire​ ​assessment​ ​will​ ​be​ ​video-recorded​ ​for​ ​future​
​reference.​​Now​​the​​[Rutgers​​RA]​​will​​join​​and​​start​​the​​assessment.​​I​​will​​stay​​muted​​until​
​the assessment is over, but if you have a question, please feel free ask to me.​”​
​○​
​●​ ​The​​UMass​​RA​​will​​bring​​the​​Rutgers​​RA​​back​​to​​the​​main​​meeting​​room​​and​​start​​recording​​the​
​assessment​.​
​●​ ​Five​​different​​Assessment​​Form​​(1-5)​​instruments​​have​​a​​different​​randomized​​order​​of​​tests.​
​RAs​​select​​an​​assessment​​form​​using​​Assessment/Assessment​​Form​​Assignment.xlsx​​in​​Google​
​drive. Then, the questions and fields of the selected​​Assessment Form instrument​​will appear.​
​●​ ​The​​Rutgers​​RA​​will​​administer​​all​​the​​assessments​​and​​enter​​all​​answers​​to​​the​​corresponding​
​Assessment​​Form​​instrument​.​​The​​Rutgers​​RA​​will​​score​​the​​participant​​as​​he/she​​administers​
​the assessments.​
​○​ ​(​Videoconference​ ​version​)​​Montreal​​Cognitive​​Assessment​​(​MoCA​):​​Chapman,​​J.​​E.,​
​Cadilhac,​ ​D.​ ​A.,​ ​Gardner,​ ​B.,​ ​Ponsford,​ ​J.,​ ​Bhalla,​ ​R.,​ ​&​ ​Stolwyk,​ ​R.​ ​J.​ ​(2019).​
​Comparing​ ​face-to-face​ ​and​ ​videoconference​ ​completion​ ​of​ ​the​ ​Montreal​ ​Cognitive​
​Assessment​ ​(MoCA)​ ​in​ ​community-based​​survivors​​of​​stroke.​​Journal​​of​​telemedicine​
​and telecare​, 1357633X19890788.​
​○​ ​(​Videoconference​ ​version​)​ ​Mini-Mental​ ​State​ ​Examination​ ​(​MMSE​):​ ​Timpano,​ ​F.,​
​Pirrotta,​​F.,​​Bonanno,​​L.,​​Marino,​​S.,​​Marra,​​A.,​​Bramanti,​​P.,​​&​​Lanzafame,​​P.​​(2013).​
​Videoconference-based​​mini​​mental​​state​​examination:​​a​​validation​​study.​​Telemedicine​
​and e-Health​,​​19​(12), 931-937.​
​○​ ​(​Original​)​ ​Digit​ ​Forward​ ​Span​ ​(​DFS​​from​​WAIS-IV):​​Powell,​​D.​​H.,​​&​​Hiatt,​​M.​​D.​
​(1996).​​Auditory​​and​​visual​​recall​​of​​forward​​and​​backward​​digit​​spans.​​Perceptual​​and​
​Motor Skills​,​​82​(3_suppl), 1099-1103.​
​○​ ​(​Original​)​​Digit​​Backward​​Span​​(​DBS​​from​​WAIS-IV):​​Powell,​​D.​​H.,​​&​​Hiatt,​​M.​​D.​
​(1996).​​Auditory​​and​​visual​​recall​​of​​forward​​and​​backward​​digit​​spans.​​Perceptual​​and​
​Motor Skills​,​​82​(3_suppl), 1099-1103.​
​○​ ​(​Original​) Geriatric Depression Scale (​GDS​)​
​○​ ​(​Original​) Short Form 36 (​SF-36​)​
​○​ ​(​Original​)​ ​Alzheimer’s​ ​Disease​ ​Cooperative​ ​Study/ADL​ ​scale​ ​adapted​ ​for​ ​MCI​
​participants (​ADCS/MCI/ADL24​)​
​●​ ​When​ ​the​ ​Rutgers​ ​RA​ ​completes​ ​the​ ​assessments,​​he/she​​will​​message​​the​​UMass​​RA​​in​​the​
​smart phone texting group.​
​●​ ​The UMass RA will unmute.​

​●​ ​The Rutgers RA will leave.​
​●​ ​The​​UMass​​RA​​enters​​the​​address​​in​​the​​Address​​to​​ship​​the​​tablet​​computer​​field​​of​​the​​MCI​
​Participant Demographics instrument​.​
​●​ ​The UMass RA will inform the participant about the assignment result and explain the schedule.​
​○​ ​Group A​
​■​ ​Message:​​“​Do​​you​​have​​any​​questions​​so​​far?​​If​​not,​​I​​would​​like​​to​​explain​​what​
​will​​happen​​next.​​We​​will​​ask​​you​​to​​play​​Neuro-World​​for​​30​​minutes​​a​​day,​​2​
​days​​a​​week​​for​​12​​weeks.​​(accurate​​exactly​​two​​days,​​separate​​day)​​We​​already​
​installed​​the​​cognitive​​training​​program,​​Neuro-World,​​in​​the​​table​​computer​​we​
​sent.​​Also,​​we​​will​​call​​you​​twice​​a​​week​​to​​follow​​up​​your​​training.​​The​​call​​will​
​take​​1-2​​minutes​​to​​briefly​​follow​​up​​on​​your​​training​​and​​thoughts​​related​​to​​the​
​training.​​Before​​you​​start​​the​​training​​with​​the​​Neuro-World​​game,​​We​​will​​need​
​to​​schedule​​a​​training​​session​​where​​we​​will​​go​​over​​all​​the​​games​​together​​and​
​help​​you​​learn​​how​​to​​play​​all​​those​​games.​​It​​will​​take​​about​​one​​hour​​to​​go​​over​
​all the games. When would be available to you this week or next week?​​”​
​○​ ​Group​​B:​​“​Do​​you​​have​​any​​questions​​so​​far?​​If​​not,​​I​​will​​start​​to​​check​​your​​physical​
​and​​cognitive​​activity​​about​​next​​week.​​I​​will​​send​​surveys​​to​​you​​very​​simple​​questions​
​three​​times​​a​​week​​and​​call​​you​​twice​​a​​weak.​​The​​phone​​call​​will​​take​​about​​2​​minutes.​
​12​​weeks​​from​​now,​​we​​will​​ask​​you​​to​​play​​the​​cognitive​​training​​game,​​Neuro-World.​
​Until then, we will follow up with you twice a week.​”​
​- All participants will be assessed using the following tests.​
​●​ ​We will use the original assessment if it is a questionnaire that can easily be done online.​
​●​ ​We​​will​​use​​the​​modified​​version​​for​​the​​videoconference-based​​administration​​(as​​opposed​​to​
​telephone-based),​​if​​the​​original​​assessment​​is​​difficult​​to​​be​​done​​online.​​(According​​to​​Becky​
​Ready)​​Some​​assessment​​tools,​​such​​as​​MoCA​​and​​MMSE,​​also​​test​​the​​visuospatial​​function​​of​
​participants.​ ​The​ ​participants’​ ​performance​ ​on​ ​visuospatial-related​ ​questions​ ​is​ ​important​
​information​ ​as​ ​well,​ ​which​ ​makes​ ​the​ ​videoconference-based​ ​version​ ​superior​ ​to​ ​the​
​telephone-based version.​
​-​​The​​convention​​for​​naming​​the​​video-recorded​​interactions.​​P1_A1_20210623.mp4​​(participant​​number,​
​event type and number, date)​
​●​ ​Assessments (before, after, follow-up) [A1, A2, A3]​
​●​ ​Weekly check-ups [C1, C2, ...]​
​●​ ​participants’ initiated questions [Q1, Q2, ...]​
​●​ ​Online workshops [W]​
​-​​The​​computer​​that​​the​​researchers​​initially​​record​​audios/videos​​need​​to​​be​​encrypted​​(e.g.,​​Windows​​10​
​BitLocker Drive Encryption) and password-protected.​

​6. Shipping tablet PC​​(UMass RA will perform)​
​-​​A​​UMass​​RA​​will​​ship​​a​​tablet​​computer,​​a​​return​​label,​​and​​a​​hardcopy​​instruction​​for​​returning​​the​
​tablet computer to the participant’s address.​
​●​ ​The​​UMass​​RA​​will​​generate​​the​​shipping​​label​​using​​the​​UMass​​paying​​account​​(​F2E075​)​​and​
​the​​participant’s​​address​​stored​​in​​the​​Address​​to​​ship​​the​​tablet​​computer​​field​​of​​the​​MCI​
​Participant Demographics instrument​.​
​○​ ​https://www.easyship.com/blog/prepaid-return-labels​
​○​ ​https://www.ups.com/us/en/campusship-support/return-services.page​
​●​ ​The UMass RA will generate the returning label.​
​●​ ​The UMass RA will perform a factory reset on a tablet computer to be shipped.​
​●​ ​The UMass RA will perform all the updates.​
​●​ ​The UMass RA will install Neuro-World.​
​●​ ​The UMass RA will enter the study ID in Neuro-World.​
​●​ ​The UMass RA will double-check to make sure Neuro-World works as expected.​
​●​ ​The UMass RA will print out the instructions.​
​●​ ​The​ ​UMass​ ​RA​ ​will​​wrap​​the​​tablet​​+​​plastic​​case​​in​​a​​bubble​​wrap,​​put​​it​​in​​the​​air-inflated​
​laptop package, and put it in the box.​
​●​ ​The UMass RA will put the printed instructions and the returning label in the box.​
​●​ ​The UMass RA will seal the box using scotch tape.​
​●​ ​The​​UMass​​RA​​will​​put​​a​​shipping​​label​​on​​the​​box​​and​​place​​it​​in​​the​​on-campus​​UPS​​pick-up​
​location.​
​●​ ​The​​UMass​​RA​​will​​text​​and​​email​​both​​the​​participant​​and​​the​​caregiver​​about​​the​​estimated​
​delivery date.​
​●​ ​The​​UMass​​RA​​will​​enter​​the​​shipped​​date,​​and​​the​​tracking​​number​​in​​the​​Shipped​​Date​​field​
​(​both​​Shipping​​to​​the​​subject​​from​​the​​UMass​,​ ​Returning​​to​​the​​UMass​​from​​the​​subject)​​of​
​the Tablet Ship & Return instrument​.​
​- A UMass RA will track the delivery of the tablet computer.​
​●​ ​The​​UMass​​RA,​​on​​his/her​​assigned​​date,​​will​​check​​if​​any​​of​​the​​tablet​​computers​​are​​estimated​
​to have arrived.​
​●​ ​The UMass RA tracks the delivery using the tracking number.​
​●​ ​If the package is reported to be delivered,​
​○​ ​The​ ​UMass​ ​RA​ ​will​ ​call​ ​the​ ​participant​ ​(the​ ​caregiver​ ​if​ ​the​ ​participant​ ​cannot​ ​be​
​reached) and confirm the delivery.​
​○​ ​If the participant (or the caregiver) confirms the receipt of the tablet computer,​
​■​ ​The​ ​UMass​ ​RA​ ​will​ ​schedule​ ​a​ ​tutorial​ ​session​ ​when​ ​the​ ​participant,​ ​the​
​caregiver, and one UMass RA are available based on the Google calendar.​
​(AHHA lab account,​​umass.ahha.lab@gmail.com​)​
​■​ ​The​​UMass​​RA​​will​​notify​​the​​responsible​​UMass​​RA​​for​​the​​tutorial​​(the​​UMass​
​RA,​​who​​schedules​​the​​tutorial​​session,​​may​​not​​be​​the​​one​​who​​is​​available​​for​
​the tutorial session).​
​○​ ​If the participant (or the caregiver) did not receive the package,​
​■​ ​The UMass RA will contact UPS and file a claim for the missing tablet computer.​
​■​ ​The UMass RA will ship another tablet computer to the participant.​
​- Purchase items through Deb (​bergeron@cs.umass.edu​).​

​7. Tutorial for the intervention group​​(UMass RA will​​perform)​
​- A UMass RA will remind the participant and the caregiver of the scheduled tutorial.​
​●​ ​Give​​a​​call​​to​​the​​participant​​and​​the​​caregiver,​​remind​​them​​1​​day​​before​​the​​scheduled​​tutorial​​in​
​the following order.​
​○​ ​Phone call​
​○​ ​If not answering, text and email.​
​●​ ​Give a call to the participant and the caregiver, remind them 2 hours before the scheduled tutorial.​
​○​ ​Phone call​
​○​ ​If not answering, text and email.​
​- The UMass RA will organize the zoom meeting.​
​●​ ​The UMass RA will initiate a zoom meeting.​
​●​ ​A​​UMass​​RA​​will​​email​​a​​zoom​​link​​to​​the​​participant’s​​email​​approximately​​10​​minutes​​before​
​the scheduled time.​
​●​ ​When the participant join, the UMass RA will start​​video-recording​​and start the tutorial session.​
​○​ ​Important points:​
​■​ ​How​​to​​use​​the​​tablet​​computer.​​(Prepare​​a​​video​​presentation​​with​​Share​​sound​
​&​​Optimize for video clip​​toggled)​
​●​ ​Open a cover​
​●​ ​How to turn on​
​●​ ​How to unlock​
​●​ ​How to lock​
​●​ ​How to wake (from the sleeping mode)​
​●​ ​How to charge​
​●​ ​How to change the volume​
​●​ ​How to set up a wifi connection​
​■​ ​How to use Neuro-World.​
​●​ ​How to run​
​○​ ​It takes a few seconds​
​●​ ​Layout of the buttons (menus) on the initial screen​
​○​ ​Tutorial on game mechanics​
​■​ ​Encourage​​participants​​to​​go​​through​​the​​tutorial​​at​​the​
​presence of connecting researchers​
​■​ ​Answer any questions that the participants ask.​
​○​ ​Daily training​
​■​ ​Six​ ​games​ ​will​ ​be​ ​presented​ ​to​ ​the​ ​participant​ ​in​ ​a​
​random order every time​
​■​ ​A​​timer​​will​​keep​​track​​of​​the​​time​​that​​the​​participant​
​plays each game​
​■​ ​When​​5​​minutes​​are​​up,​​the​​participant​​will​​be​​moved​​to​
​the next game​
​■​ ​When​​the​​participant​​plays​​all​​6​​games,​​the​​daily​​training​
​will be done​
​●​ ​How to exit​
​-​ ​The​ ​UMass​ ​RA​ ​will​ ​inform​ ​the​ ​participant​ ​and​ ​the​ ​caregiver​ ​about​ ​the​​self-administration​​and​​the​
​weekly follow-up.​
​●​ ​The UMass RA informs that​
​○​ ​The participant can start self-administration of Neuro-World on the subsequent Monday.​

​○​ ​(Optional)​​The​​caregiver​​can​​help​​the​​participant​​to​​operate​​the​​tablet​​computer​​or​​start​
​the daily training.​
​○​ ​(Optional)  The caregiver cannot help the participant play the games.​
​○​ ​The​​researcher​​(i.e.,​​a​​UMass​​RA)​​will​​contact​​the​​participant​​or​​the​​caregiver​​separately​
​to ask about any potential issues.​
​○​ ​Should​​they​​have​​any​​questions,​​the​​participant​​or​​the​​caregiver​​can​​contact​​the​​UMass​
​RA​​anytime​​through​​a​​phone​​call​​or​​an​​email​​to​​schedule​​a​​meeting.​​→​​Zoom​​link​
​will be sent at a scheduled time. Video-record interactions.​
​- The UMass RA will store the video-recording in the MS OneDrive​
​●​ ​The​ ​UMass​ ​RA​ ​will​ ​initially​ ​store​ ​the​ ​Zoom​ ​video-recording​ ​in​ ​the​ ​encrypted​ ​&​
​password-protected local computer.​
​●​ ​The​​UMass​​RA​​will​​upload​​the​​file​​to​​the​​HIPAA-compliant​​cloud​​storage​​supported​​by​​UMass​
​Amherst (MS OneDrive)​
​●​ ​The UMass RA will remove the file from the local computer.​

​8. Checking compliance every week​​(UMass RA will​​perform)​
​- UMass RAs will follow up with the participant twice a week for 24 weeks by phone call.​
​-​​If​​the​​caregiver​​participates​​in​​the​​study,​​UMass​​RAs​​will​​follow​​up​​with​​the​​caregiver​​once​​a​​week​​for​
​24 weeks by phone call.​
​●​ ​The phone follow-up will be audio-recorded.​
​●​ ​For the participant,​
​○​ ​During the experiment period​
​■​ ​When the participant successfully adheres to Neuro-World training, a casual​
​follow-up.​
​●​ ​Message: “​How is Neuro-World training going?​​Are there​​any significant​
​changes in your daily activities? Could you explain in more detail?​
​Thank you.”​
​■​ ​When the participant missed Neuro-World training this week, try to understand​
​what hinders the participant’s low adherence.​
​●​ ​Message: “I noticed that you have not played Neuro-World this week. Is​
​everything ok? Do you need any help?”​
​■​ ​At the last follow-up call, ask the participant to return the tablet computer &​
​arrange the 1:1 interview.​
​●​ ​Message: “So, this week is your last Neuro-World training. Would you​
​be able to return the tablet computer? Please wrap the tablet computer​
​using bubble wrap. Put the wrapped tablet computer and the charger in​
​the air-inflated package. Put the package in the paper box. Put the​
​returning label on the box.”​
​●​ ​The RA will schedule the earliest available time for the participant and​
​both UMass RAs.​
​(AHHA lab account,​​umass.ahha.lab@gmail.com​)​
​●​ ​For more details about the interview, refer to​​11.​​Interview.​
​○​ ​During the control period​
​■​ ​Message: (for MCI participant) “Are there any significant changes in your daily​
​activities? Could you explain in more detail? Thank you.”​
​■​ ​Message: (for helper, optional) “Are there any significant changes in [NAME]’s​
​daily activities? Could you explain in more detail? Thank you.”​
​○​ ​The RA enters the date that he/she made a call to the participant and whether he/she was​
​successful connecting with the participant​​in the​​Follow-up field​​of​​the Weekly​
​Follow-up instrument​.​
​●​ ​For the caregiver (optional),​
​○​ ​During the experiment period​
​■​ ​When the participant successfully adheres to Neuro-World training, try to​
​understand the third-person perspective of the participant’s adherence to​
​Neuro-World training.​
​●​ ​Message:​​“Can you tell me about how the participant​​plays Neuro-World​
​training? Does he enjoy playing it? Does he focus when plays​
​Neuro-World?”​
​■​ ​When the participant missed Neuro-World training this week, try to ask if the​
​caregiver can encourage the participant to play Neuro-World.​
​●​ ​Message: “Can you tell me about how the participant plays Neuro-World​
​training? Does he enjoy playing it? Does he focus when plays​
​Neuro-World? I noticed that the participant has not played Neuro-World​

​this week. Would you be able to encourage the participant to play​
​Neuro-World x times this week?”​
​■​ ​At the last follow-up call, ask the participant to return the tablet computer.​
​●​ ​Message: “So, this week is the participant’s last Neuro-World training.​
​Would you be able to help him/her to return the tablet computer? Please​
​wrap the tablet computer using bubble wrap. Put the wrapped tablet​
​computer and the charger in the air-inflated package. Put the package in​
​the paper box. Put the returning label on the box.”​
​●​ ​The RA will schedule the earliest available time for the caregiver and​
​both UMass RAs.​
​(AHHA lab account,​​umass.ahha.lab@gmail.com​)​
​●​ ​For more details about the interview, refer to​​11.​​Interview.​
​○​ ​The RA enters the date that he/she made a call to the participant and whether he/she was​
​successful connecting with the participant​​in the​​Follow-up field​​of​​the Weekly​
​Follow-up instrument​.​
​- UMass RAs will follow up with the participant three times a week for 24 weeks by REDCap survey.​
​-​​If​​the​​caregiver​​participates​​in​​the​​study,​​UMass​​RAs​​will​​follow​​up​​with​​the​​caregiver​​once​​a​​week​​for​
​24 weeks by REDCap survey.​
​●​ ​For the participant,​
​○​ ​In​ ​the​ ​past​ ​two​​days,​​did​​you​​do​​any​​COGNITIVE​​activities​​such​​as​​Sudoku,​
​board​​games,​​word​​games,​​or​​any​​other​​activities​​you​​do​​to​​help​​your​​memory​
​and mental capacity?​
​○​ ​If yes, how long?​
​○​ ​In​​the​​past​​two​​days,​​did​​you​​do​​any​​PHYSICAL​​activities​​or​​exercise​​such​​as​
​going​​for​​a​​walk,​​biking,​​swimming,​​exercise​​videos/classes​​or​​anything​​else​​you​
​can think of?​
​○​ ​If yes, how long?​
​●​ ​For the caregiver (optional),​
​○​ ​During this week, did you meet the participant?​
​○​ ​In​​the​​past​​two​​days,​​did​​you​​see​​the​​participant​​do​​any​​COGNITIVE​​activities​
​such​​as​​Sudoku,​​board​​games,​​word​​games,​​or​​any​​other​​activities​​you​​do​​to​​help​
​your memory and mental capacity?​
​○​ ​If yes, how long?​
​○​ ​In​​the​​past​​two​​days,​​did​​you​​see​​the​​participant​​do​​any​​PHYSICAL​​activities​​or​
​exercise​​such​​as​​going​​for​​a​​walk,​​biking,​​swimming,​​exercise​​videos/classes​​or​
​anything else you can think of?​
​○​ ​If yes, how long?​

​9.​​Assessment​​after​​12​​weeks​​(Only​​Rutgers​​RA​​can​​perform​​assessment;​
​UMass RAs will organize the overall meeting)​
​- After​​12​​weeks, all participants will be assessed​​with the following tests​​online (via zoom)​.​
​Detailed steps will be the same as the baseline assessment.​
​RAs​​will​​generate​​a​​new​​form​​for​​recording​​12​​weeks​​follow-up​​assessment​​from​​the​​corresponding​
​Assessment Form instrument.​

​10. Returning tablet PC​​(UMass RAs will perform)​
​- A UMass RA will track the returning delivery of the tablet computer.​
​●​ ​The​ ​UMass​ ​RA​ ​should​ ​have​ ​instructed​ ​the​ ​participant​ ​or​ ​the​ ​caregiver​ ​to​ ​return​ ​the​ ​tablet​
​computer. If not,​
​○​ ​Call​​the​​participant​​or​​the​​caregiver​​to​​provide​​the​​instructions.​​(Refer​​to​​8.​​Checking​
​compliance every week​)​
​●​ ​The​ ​UMass​ ​RA,​ ​who​ ​is​ ​on​ ​the​ ​designed​ ​days,​ ​will​ ​check​ ​the​​tracking​​number​​based​​on​​the​
​Tracking​ ​number​ ​field​ ​(​Returning​ ​to​ ​the​ ​UMass​​from​​the​​subject​)​​of​​the​​Tablet​​Ship​​&​
​Return instrument​. The following is an example.​
​○​ ​UMass RA1: Wed​
​○​ ​UMass RA2: Fri​
​○​ ​If the returning package has been picked up by the UPS,​
​■​ ​Enter​ ​the​ ​date​ ​in​ ​the​ ​Shipped​ ​date​ ​field​ ​of​ ​the​ ​Tablet​ ​Ship​ ​&​ ​Return​
​instrument​.​
​○​ ​If the returning package is shown delivered,​
​■​ ​The RA will retrieve the tablet computer.​
​■​ ​The​​RA​​will​​check​​if​​both​​the​​tablet​​computer​​and​​the​​charger​​are​​included​​in​​the​
​box.​
​○​ ​If the returning package is shown delivered but the package is not delivered,​
​■​ ​The RA will contact the UPS and file a claim.​

​11. Interview​​(UMass RAs will perform)​
​- A UMass RA will remind the participant and the caregiver of the scheduled interview.​
​●​ ​Give​​a​​call​​to​​the​​participant​​and​​the​​caregiver,​​remind​​them​​1​​day​​before​​the​​scheduled​​interview​
​in the following order.​
​○​ ​Phone call​
​○​ ​If not answering, text and email.​
​●​ ​Give​ ​a​ ​call​ ​to​ ​the​ ​participant​ ​and​ ​the​ ​caregiver,​ ​remind​ ​them​ ​2​ ​hours​ ​before​ ​the​ ​scheduled​
​interview.​
​○​ ​Phone call​
​○​ ​If not answering, text and email.​
​- Both UMass RAs and PIs (if applicable) will attend the interview.​
​●​ ​One UMass RA will initiate a zoom meeting.​
​●​ ​The​​UMass​​RA​​will​​email​​a​​zoom​​link​​to​​the​​participant​​(or​​the​​caregiver),​​another​​UMass​​RA,​
​and PIs approximately 10 minutes before the scheduled time.​
​- List of potential questions for the participant.​
​●​ ​What​​information​​and​​how​​do​​participants​​want​​to​​receive​​to​​better​​comprehend​​their​​cognitive​
​performance and their compliance behaviors (frequency and duration)?​
​○​ ​Can you tell us which Neuro-World games you did well?​
​○​ ​How well did you do those games?​
​○​ ​Can you tell us which Neuro-World games you did poorly?​
​○​ ​How poorly did you do those games?​
​○​ ​Is​​there​​anything​​else​​you​​want​​to​​know​​about​​your​​performance​​while​​you​​were​​playing​
​those games?​
​○​ ​Did you enjoy playing Neuro-World games?​
​○​ ​What did you enjoy about playing Neuro-World games?​
​○​ ​What did you not enjoy about playing Neuro-World games?​
​○​ ​Can​ ​you​ ​tell​​us​​if​​knowing​​your​​performance​​in​​Neuro-World​​games​​helped​​you​​play​
​Neuro-World routinely?​
​○​ ​What other information would help you adhere to playing Neuro-World routinely?​
​●​ ​What​​is​​the​​optimal​​design​​of​​the​​feedback​​mechanism​​(content,​​medium,​​and​​timing)​​to​​remind​
​participants to self-administer the training?​
​○​ ​What​ ​made​ ​it​ ​easy​ ​to​ ​access​ ​the​ ​information​ ​about​ ​your​ ​performance​ ​in​ ​playing​
​Neuro-World games?​
​○​ ​What​ ​made​ ​it​ ​difficult​ ​to​ ​access​ ​the​ ​information​ ​about​ ​your​ ​performance​ ​in​ ​playing​
​Neuro-World games?​
​○​ ​How can we present the information so that you can access it more easily?​
​○​ ​What made it easy to understand the information about your performance?​
​○​ ​What made it difficult to understand the information about your performance?​
​○​ ​How can we present the information so that you can understand more easily?​
​○​ ​How many times or often did you access the information about your performance?​
​○​ ​How​​often​​would​​you​​be​​willing​​to​​access​​the​​information​​if​​it​​were​​presented​​in​​a​​way​
​you preferred?​
​●​ ​Are​​there​​any​​interaction​​barriers,​​such​​as​​video/audio​​instructions​​that​​may​​not​​be​​sufficiently​
​informative,​​for​​participants​​to​​use​​the​​system,​​which​​have​​not​​been​​observed​​in​​our​​preliminary​
​studies?​
​○​ ​What made it easy to play Neuro-World?​

​○​ ​What made it difficult to play Neuro-World?​
​○​ ​Did you find the Tutorial easy to understand?​
​○​ ​Did you find the instructions in the games easy to understand?​
​○​ ​Was it easy to navigate the menu?​
​○​ ​How do you think we can improve the menu?​
​●​ ​Any comments?​
​○​ ​Is there anything else you want to share with us?​
​- List of potential questions for the caregiver.​
​●​ ​How often did you have to remind the participant?  Was this a burden for you?​
​●​ ​How much assistance did you have to provide help to participants?​
​●​ ​Did the participant avoid, complain, or otherwise protest when it was time to play Neuro-World?​
​●​ ​What advice do you have for us as we move forward with this research on Neuro-World training​
​for persons diagnosed with MCI?​

​12.​ ​Assessment​ ​after​ ​24​ ​weeks​ ​(Only​ ​Rutgers​ ​RA​ ​can​ ​perform​
​assessment; UMass RAs will organize the overall meeting)​
​- After​​24​​weeks, all participants will be assessed​​with the following tests​​online (via zoom)​.​
​Detailed steps will be the same as the baseline assessment.​
​RAs​​will​​generate​​a​​new​​form​​for​​recording​​24​​weeks​​follow-up​​assessment​​from​​the​​corresponding​
​Assessment Form instrument.​

​Towards the Development of a Mobile-Health Technology Based on Serious Game-based​
​Interventions in Adults with MCI outside the clinic​
​Purpose​
​The purpose of this study is to learn: 1) if Neuro-World (mobile cognitive training games) can​
​improve the cognitive function of adults with mild cognitive impairment (MCI), 2) if we can​
​understand the cognitive function of adults with MCI based on their performance in​
​Neuro-World, and 3) if we can learn practical challenges that adults with MCI face while playing​
​Neuro-World.​
​Neuro-World​
​A tablet computer with pre-installed Neuro-world cognitive training games will be provided​
​during the study.​
​Eligibility​
​Adults with MCI​​are eligible for the study if you​​1) have mild cognitive impairment (we will​
​assess your impairment level for you), 2) are 55 years old or older, 3) can use a tablet​
​independently, and 4) have access to a computer for online video communication (e.g., Zoom).​
​Adults with MCI CANNOT participate in this study if you have 1) another neurologic or​
​psychiatric disorder, 2) history of traumatic brain injury, 3) uncorrected hearing or vision​

​impairment, 4) any significant impairment in your arms that could affect tablet use, 5) diagnosis​
​of dementia with Lewy bodies, progressive supranuclear palsy, multiple system atrophy, or​
​vascular parkinsonism, 6) diagnosis of dementia, and 7) participation of any other​
​therapist-supervised cognitive training.​
​If you need help navigating technology (such as using Zoom or mobile apps), you can choose to​
​have a friend or family member help you throughout this study. If you choose this option, they​
​will be enrolled in the study with you. In that case, helpers need to 1) be 18 years or older, 2)​
​understand your condition, and 3) can be contacted by the study team regularly. The person is​
​not eligible if he/she 1) has been specifically hired to provide care for you and 2) has any​
​impairments that prevent them from helping you.​
​Task​
​1.​​We will ask​​adults with MCI​​to do one of the following​​for the study (not both).​
​Group A: 1)​​We will ask you to play Neuro-World cognitive​​training games 30 minutes per day,​
​twice a week for 12 weeks in your home setting. During this period, we will give you phone calls​
​and ask if you adhere to the cognitive training and ask you to report the time of any additional​
​cognitive and physical activities three times a week.​​2)​​Upon completing 24 sessions, we will​
​ask you to join online sessions (e.g., Zoom) to share your experience of using Neuro-World​​3)​
​Then, we will give you phone calls and ask if you have any significant changes in the level of​
​daily activities for another 12 weeks and ask you to report the time of any additional cognitive​
​and physical activities three times a week. This study lasts about six months, and you will spend​
​about 27.2 hours in total.​
​Group B: 1)​​We will give you phone calls and ask if​​you have any significant changes in the​
​level of daily activities for 12 weeks and ask you to report the time of any additional cognitive​
​and physical activities three times a week.​​2)​​After​​the 12 weeks, we will ask you to play​
​Neuro-World cognitive training games 30 minutes per day, twice a week for 12 weeks in your​
​home setting. During this period, they will give you phone calls and ask if you adhere to the​
​cognitive training and ask you to report the time of any additional cognitive and physical​
​activities three times a week.​​3)​​Upon completing​​24 sessions, we will ask you to join online​
​sessions (e.g., Zoom) to share your experience of using Neuro-World. This study lasts about six​
​months, and you will spend about 27.2 hours in total.​

​2.​​If helpers participate in the study, we will ask​​helpers​​to do the following for the study.​
​1)​​We will ask you to check on adults with MCI you​​are helping if they do not adhere to cognitive​
​training.​​2)​​We will ask you to assist adults with​​MCI in using a tablet computer and online​
​communication technology as necessary.​​3)​​During the​​entire study, we will ask you to report the​
​time of any cognitive and physical activities adults with MCI engage in once per week.​​4)​​During​
​the 12-week period that adults with MCI use Neuro-World, we will contact you and ask for your​
​perspective on their adherence to Neuro-World cognitive training.​​5)​​During the 12-week control​
​period, we will contact you and ask if there are any significant changes in the activities of adults​
​with MCI.​​6)​​Upon the completion of 12-week Neuro-World​​play, we will ask you to participate in​
​a 1:1 interview to hear your experience and opinions as a helper. This study lasts about six​
​months, and you will spend 4.4 hours in total for an interview and follow-up calls. You may need​
​to spend an additional 27.2 hours in total. However, you will be asked for help only when it is​
​necessary.​
​Compensation:​
​Adults with MCI will receive $2 after each Neuro-World play and $34 for each suite of cognitive​
​assessments, which amount to a total of $150. If helpers participate in the study, helpers will​
​receive $1 for each week of support and $13 for each 1:1 interview, which amounts to a total of​
​$50.​
​If you are interested in participating or want to know more, please contact the AHHA Lab​
​(413-545-8875, umass.ahha.lab@gmail.com).​

​For Adults with MCI​
​Thank you for speaking with us today. Before you officially enroll in this research study, I will be​
​asking you to complete a screening questionnaire. It should take you no more than 30 minutes​
​to complete. If you are determined ineligible to participate, your completed questionnaire will be​
​destroyed. If you are determined eligible to participate, the completed questionnaire will become​
​part of the study materials, and we will protect your information as confidential and safeguard it​
​from unauthorized disclosure. Only research personnel will have access to the information​
​contained in your screening questionnaire. If the screening questionnaire indicates that you are​
​eligible to participate, we will proceed to obtaining your written informed consent for participation​
​in the study. Do you have any questions?​
​The contacted researcher will ask the following questions regarding the inclusion criteria (2​
​minutes).​
​1. Are you 55 years old or older?​
​2. Can you turn on/off a smartphone or a tablet computer? Can you start an application and use​
​it on your smartphone or a tablet computer? It is ok to receive help from your caregiver on​
​operating your smartphone or tablet computer.​
​3. Do you have access to a computer for online video communication (e.g., Zoom, Microsoft​
​Team, Google Hangouts)?​
​The contacted researcher will ask the following questions regarding the exclusion criteria (5​
​minutes).​
​1. Do you have diagnosed neurologic or psychiatric disorders other than mild cognitive​
​impairment?​
​2. Do you have a history of diagnosed traumatic brain injury?​
​3. Do you have hearing or vision impairment that can hinder you from playing games?​
​4. Do you have any significant impairment in your arm that could affect the use of a tablet​
​computer?​
​5. Do you have diagnosed dementia with Lewy bodies, progressive supranuclear palsy, multiple​
​system atrophy, or vascular parkinsonism?​
​6. Do you have diagnosed dementia?​
​7. Are you receiving any therapist-supervised cognitive training?​
​For Caregivers (optional)​
​The contacted researcher will ask the following questions regarding the inclusion/exclusion​
​criteria (2 minutes).​

​Inclusion criteria​
​1. Are you 18 years old or older?​
​2. Do you know about your care receiver’s health conditions?​
​3. Will you be willing to be contacted by the researchers on a regular basis in case your care​
​receiver needs external help?​
​Exclusion criteria​
​4. Are you hired to provide care for your care receiver?​
​5. Do you have any cognitive, behavioral, or motor impairments that can affect assisting your​
​care receiver in the study?​

​ATTENTION​
​When you open the box, CHECK if the following items are in the box.​
​1.​​One air-filled container​
​2.​​One tablet (in the air-filled container)​
​3.​​One tablet cover (a tablet is in the cover)​
​4.​​One charger (in the air-filled container)​
​5.​​One UPS return label​
​Please KEEP EVERYTHING you received that includes the following.​
​1.​​One outer box​
​2.​​One air-filled container​
​3.​​One tablet​
​4.​​One tablet cover​
​5.​​One charger​
​6.​​One UPS return label​
​Please DO NOT START cognitive training games until the researchers​
​contact you.​
​When the study is complete, the researchers will contact and ask you​
​to return all the items. At the time, you will need to do the following.​
​1.​​Place the tablet (with its cover) in the air-filled container.​
​2.​​Place the charger in the air-filled container.​
​3.​​Place the air-filled container (with the tablet, the charger inside)​
​in the outer box.​
​4.​​Seal the outer box.​
​5.​​Put the UPS return label on the outer box.​
​6.​​Place the box outside your front door.​

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