CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 60 enrolled
Drug / intervention
The MapHabit system (MHS)device
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05422339
NCT05422339N/ACompleted

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

MapHabit, Inc.·interventional·Posted Jun 16, 2022·Updated Sep 29, 2025

In Brief

A clinical study evaluating The MapHabit system (MHS) for Alzheimer Disease and 3 related conditions. Completed, enrolled 60 participants across 1 site.

Detailed Summary

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 Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedJun 16, 2022
Enrollment StartSep 12, 2022
Primary CompletionDec 28, 2023
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.0 years ago

Interventions

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.