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OpenTrials
Completed

NCT Number: NCT05422339

Efficacy of Gamification in Enhancing User Engagement

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.

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Key information

Conditions

Alzheimer Disease Assistive Technology Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Gamification Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Stress, Psychological Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MapHabit

Atlanta, Georgia, 30308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

MapHabit, Inc.

Industry

Registry information

Official study title

Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2022
Registry last updated
Sep 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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