Efficacy of Gamification in Enhancing User Engagement

September 8, 2025 updated by: Stuart Zola, MapHabit, Inc.

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Georgia
      • Atlanta, Georgia, United States, 30308
        • MapHabit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gamified Intervention
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.

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.

Active Comparator: Non-gamified Intervention
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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)
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.
The instrument was administered to the participants once -- at the end of their participation in the 6 month study.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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.
The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Stuart Zola, MapHabit, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 12, 2022

Primary Completion (Actual)

December 28, 2023

Study Completion (Actual)

December 28, 2023

Study Registration Dates

First Submitted

June 7, 2022

First Submitted That Met QC Criteria

June 13, 2022

First Posted (Actual)

June 16, 2022

Study Record Updates

Last Update Posted (Estimated)

September 29, 2025

Last Update Submitted That Met QC Criteria

September 8, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

Immediately following publication. No end date.

IPD Sharing Access Criteria

Researchers who provide a methodologically sound proposal. Proposals should be directed to szola@maphabit.com. To gain access, data requestors will need to sign a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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