Alzheimer DiseaseNCT05422339

Efficacy of Gamification in Enhancing User Engagement

A study testing The MapHabit system (MHS) in people with Alzheimer Disease and Dementia, run by MapHabit, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Alzheimer Disease, Dementia, Gamification
What is being tested?: The MapHabit system (MHS)
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 60 participants
Where: 1 siteUnited States
Study dates: 12 Sep 2022to 28 Dec 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment
Participating caregiver of individual with dementia must be the primary caregiver
Proficient in English

Who cannot join

Individual not diagnosed with ADRD
Participating caregiver of individual with dementia is NOT the primary caregiver
Not proficient in English

Trial locations and contacts

1 site in 1 country.

United States1 site

MapHabit
Atlanta, Georgia, 30308

Other trials in United States

About this study

Official title: Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology

As part of Phase II of the NIH SBIR grant, the study will conduct a randomized controlled clinical trial in which the MapHabit system's gamification is investigated to determine whether the assistive technology facilitates user engagement and retention. Additionally, the study will examine if the gamified software improves the quality of life of persons with dementia and reduce the burden of the respective care partners. Participants will be individuals with Alzheimer's disease or related dementias in mild to moderate stage of cognitive impairment, accompanied by their respective primary care partner (i.e., primary familial caregiver). The study will be a randomized controlled clinical trial, in which two conditions will be investigated: 1) experimental condition in which MHS+Gamification is implemented into the daily care received by participants 2) control condition in which the MHS alone and separate engagement material is incorporated into the participant's daily care. Sample size goal will strive for a total of 40 individual-caregiver dyads, 20 in each condition. The study duration will be a 6-month intervention.

Conditions: Alzheimer Disease, Dementia, Gamification, Assistive Technology
Being tested: The MapHabit system (MHS)
Keywords: Alzheimer disease, Dementia, Caregiver burden, activities of daily living, Assistive technology
Medical subject headings: Alzheimer Disease, Dementia, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

The MapHabit system (MHS)Device
The MapHabit System (MHS) is a commercially available visual mapping software application that utilize visual, audio, and text media to create step-by-step visual guides to assist individuals and their caregivers in structuring and accomplishing activities of daily living (ADLs). The goal of the application is to develop and facilitate habits and routines using structured visual and auditory stimuli that can be customized by the user and can include educational and lesson-based material in addition to ADLs. The application will be made available to families through compatible smartphones and tablets. Depending on the condition, participants will receive a specific version of the application. The experimental condition will receive the version that incorporates gamified content and structure.
The MHS is a general wellness product and there is no regulatory oversight of the MapHabit System mapping functionality. This functionality is not a regulated medical device.

Study groups in NCT05422339
Study group	Role	What they receive
Gamified Intervention	Experimental	This condition involved the implementation of an assistive technology software (the MapHabit system) with added gamification features into the daily care of the participants. The experimental condition received the version that incorporates gamified content and structure. Gamification involved receiving four new cognitive games each month. The cognitive games that were chosen for the current study followed game types observed to be prevalent in literature centered on serious games within dementia research. These games aim for cognitive stimulation in slowing down symptom acuity. Game design elements of positive reinforcement, problem-solving, progression, and visual cues were implemented into game content and software. Receives: Device: The MapHabit system (MHS)
Non-gamified Intervention	Active comparator	This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, will be given to a separate group of participants with mild to moderate stage of ADRD. The difference here will be that the software will be a version that does not include gamification features. The Control Group watched several 40 to 55-minute educational videos that were sent to the participants' devices each month. The content involved topics such as Happiness, Memory, Nutrition/Diet, and Mindfulness. The intent was to have the two groups engaged for about equal lengths of time in each of their respective interventions. Receives: Device: The MapHabit system (MHS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in User Interaction and Engagement From Baseline to 6 Months
Our internal analytics of the software can assess the user's interactions with the application by tracking user's map use count per month. By combining these data points, we can determine the average engagement for each participant and compare them between groups.
Measured: User engagement (i.e., map count) was collected daily for the total duration of 180 days/6 months of the subject's participation. Usage data was segmented and analyzed via monthly basis.
Quality of Life-18 (QoL-18)
18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-5. A higher number indicates better outcome.
Measured: The instrument was administered to the participants once -- at the end of their participation in the 6 month study.

Secondary outcomes (1)

2-item Satisfaction Scale (SS-2)
Quantifies participant's endorsements to two survey questions: How satisfied were they with the MHS? How much progress did they feel like they made? Both questions are scored on a 10-point scale, with a higher value reflecting a better outcome/experience.
Measured: The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Sep 202228 Dec 2023

First posted16 Jun 2022
Study start12 Sep 2022
Primary completion28 Dec 2023
Study completion28 Dec 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: The study will be a randomized controlled clinical trial, in which two conditions will be investigated: a control and experimental condition.
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05422339
Sponsor's protocol ID: Gamification Study (NIH PH II)
Status last verified: Sep 2025
First submitted: 7 Jun 2022
Last updated: 29 Sep 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

Boatman F, Golden M, Jin J, Kim Y, Law S, Lu A, Merriam N, Zola S. Assistive technology: Visual mapping combined with mobile software can enhance quality of life and ability to carry out activities of daily living in individuals with impaired memory. Technol Health Care. 2020;28(2):121-128. doi: 10.3233/THC-191980.
PubMed 31796718
Kelleher J, Zola S, Cui X, Chen S, Gerber C, Parker MW, Davis C, Law S, Golden M, Vaughan CP. Personalized Visual Mapping Assistive Technology to Improve Functional Ability in Persons With Dementia: Feasibility Cohort Study. JMIR Aging. 2021 Oct 19;4(4):e28165. doi: 10.2196/28165.
PubMed 34269690
Parker MW, Davis C, White K, Johnson D, Golden M, Zola S. Reduced care burden and improved quality of life in African American family caregivers: Positive impact of personalized assistive technology. Technol Health Care. 2022;30(2):379-387. doi: 10.3233/THC-213049.
PubMed 34334439
Montgomery B, Mammen C, Golden M. Using a Gamification Approach to Enhance Continued Use of Assistive Technology Intervention in Persons Living with Dementia. OBM Geriatrics 2025; 9(2): 311; doi:10.21926/obm.geriatr.2502311

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 29 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology
ClinicalTrials.gov ID: NCT05422339
Acronym / sponsor ID: Gamification Study (NIH PH II)
Conditions: Alzheimer Disease, Dementia, Gamification, Assistive Technology
Keywords: Alzheimer disease, Dementia, Caregiver burden, activities of daily living, Assistive technology
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: MapHabit, Inc.Industry (pharma, biotech, devices)
Study start: 12 Sep 2022 (actual)
Primary completion: 28 Dec 2023 (actual)
Study completion: 28 Dec 2023 (actual)
First posted: 16 Jun 2022 (actual)
Results: Posted 29 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, outcomes assessor)
Number of arms: 2
Model description: The study will be a randomized controlled clinical trial, in which two conditions will be investigated: a control and experimental condition.

Arm	Type	Receives
Gamified Intervention	Experimental	Device: The MapHabit system (MHS)This condition involved the implementation of an assistive technology software (the MapHabit system) with added gamification features into the daily care of the participants. The experimental condition received the version that incorporates gamified content and structure. Gamification involved receiving four new cognitive games each month. The cognitive games that were chosen for the current study followed game types observed to be prevalent in literature centered on serious games within dementia research. These games aim for cognitive stimulation in slowing down symptom acuity. Game design elements of positive reinforcement, problem-solving, progression, and visual cues were implemented into game content and software.
Non-gamified Intervention	Active comparator	Device: The MapHabit system (MHS)This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, will be given to a separate group of participants with mild to moderate stage of ADRD. The difference here will be that the software will be a version that does not include gamification features. The Control Group watched several 40 to 55-minute educational videos that were sent to the participants' devices each month. The content involved topics such as Happiness, Memory, Nutrition/Diet, and Mindfulness. The intent was to have the two groups engaged for about equal lengths of time in each of their respective interventions.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment
Participating caregiver of individual with dementia must be the primary caregiver
Proficient in English

Key exclusion criteria (3 listed)

Individual not diagnosed with ADRD
Participating caregiver of individual with dementia is NOT the primary caregiver
Not proficient in English

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
The MapHabit system (MHS)The MapHabit System (MHS) is a commercially available visual mapping software application that utilize visual, audio, and text media to create step-by-step visual guides to assist individuals and their caregivers in structuring and accomplishing activities of daily living (ADLs). The goal of the application is to develop and facilitate habits and routines using structured visual and auditory stimuli that can be customized by the user and can include educational and lesson-based material in addition to ADLs. The application will be made available to families through compatible smartphones and tablets. Depending on the condition, participants will receive a specific version of the application. The experimental condition will receive the version that incorporates gamified content and structure. The MHS is a general wellness product and there is no regulatory oversight of the MapHabit System mapping functionality. This functionality is not a regulated medical device.	Device	Gamified Intervention, Non-gamified Intervention

Primary outcome

Change in User Interaction and Engagement From Baseline to 6 Months
Time frame: User engagement (i.e., map count) was collected daily for the total duration of 180 days/6 months of the subject's participation. Usage data was segmented and analyzed via monthly basis.
Our internal analytics of the software can assess the user's interactions with the application by tracking user's map use count per month. By combining these data points, we can determine the average engagement for each participant and compare them between groups.
Quality of Life-18 (QoL-18)
Time frame: The instrument was administered to the participants once -- at the end of their participation in the 6 month study.
18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the end of the study compared to before the use of the MHS. The instrument is scored on a Likert Scale, ranging from 1-5. A higher number indicates better outcome.

1 secondary outcome

2-item Satisfaction Scale (SS-2)
Time frame: The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months)

Results and safety

Results posted to the registry on 29 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gamified Intervention	30	13
Non-gamified Intervention	30	15

Primary outcome: Change in User Interaction and Engagement From Baseline to 6 Months

Time frame: User engagement (i.e., map count) was collected daily for the total duration of 180 days/6 months of the subject's participation. Usage data was segmented and analyzed via monthly basis.. Median (Standard Deviation). Unit: Uses per Month

Measure	Gamified Intervention n = 13	Non-gamified Intervention n = 15
Month 1	32 (29.9)	60 (89.0)
Month 2	7 (29.3)	36 (79.2)
Month 3	8 (21.3)	2 (39.7)
Month 4	5 (13.2)	4 (45.8)
Month 5	4 (9.0)	3 (38.7)
Month 6	0 (16.0)	4 (25.4)

Primary outcome: Quality of Life-18 (QoL-18)

Time frame: The instrument was administered to the participants once -- at the end of their participation in the 6 month study.. Mean (Full Range). Unit: score on a scale

Measure	Gamified Intervention n = 13	Non-gamified Intervention n = 15
Value	3.3 (1 to 5)	3.6 (1 to 5)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected over the duration of the study (6 months). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gamified Intervention	1 of 30 (3.3%)	0 of 30 (0%)	1 of 30
Non-gamified Intervention	1 of 30 (3.3%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31796718Boatman F, Golden M, Jin J, Kim Y, Law S, Lu A, Merriam N, Zola S. Assistive technology: Visual mapping combined with mobile software can enhance quality of life and ability to carry out activities of daily living in individuals with impaired memory. Technol Health Care. 2020;28(2):121-128. doi: 10.3233/THC-191980.
Background: PubMed 34269690Kelleher J, Zola S, Cui X, Chen S, Gerber C, Parker MW, Davis C, Law S, Golden M, Vaughan CP. Personalized Visual Mapping Assistive Technology to Improve Functional Ability in Persons With Dementia: Feasibility Cohort Study. JMIR Aging. 2021 Oct 19;4(4):e28165. doi: 10.2196/28165.
Background: PubMed 34334439Parker MW, Davis C, White K, Johnson D, Golden M, Zola S. Reduced care burden and improved quality of life in African American family caregivers: Positive impact of personalized assistive technology. Technol Health Care. 2022;30(2):379-387. doi: 10.3233/THC-213049.
BackgroundMontgomery B, Mammen C, Golden M. Using a Gamification Approach to Enhance Continued Use of Assistive Technology Intervention in Persons Living with Dementia. OBM Geriatrics 2025; 9(2): 311; doi:10.21926/obm.geriatr.2502311
Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Stuart Zola principal investigator

MapHabit, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing The MapHabit system (MHS) in people with Alzheimer Disease and Dementia, run by MapHabit, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in User Interaction and Engagement From Baseline to 6 Months (time frame: User engagement (i.e., map count) was collected daily for the total duration of 180 days/6 months of the subject's participation. Usage data was segmented and analyzed via monthly basis.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05422339, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2025.