N/A N=60 Randomized Double-blind Supportive Care

Efficacy of Gamification in Enhancing User Engagement

Alzheimer Disease · Dementia · Gamification · Assistive Technology

Bottom Line

View on ClinicalTrials.gov: NCT05422339 ↗

Enrolled (actual)

Serious AEs

3.3%

Results posted

Sep 2025

Primary outcome: Primary: Change in User Interaction and Engagement From Baseline to 6 Months — 32; 60; 7; 36 Uses per Month

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: The MapHabit system (MHS) (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: MapHabit, Inc.
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in User Interaction and Engagement From Baseline to 6 Months	32; 60; 7; 36; 8; 2	—
PRIMARY Quality of Life-18 (QoL-18)	3.3; 3.6	—
SECONDARY 2-item Satisfaction Scale (SS-2)	6; 9; 7; 6; 7; 10	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05422339). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.