Efficacy of Gamification in Enhancing User Engagement

NCT05422339 | Completed Results

• 1 other identifier: Gamification Study (NIH PH II)
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Alzheimer Disease; Dementia; Gamification; Assistive Technology

Keywords

Alzheimer disease; Dementia; Caregiver burden; activities of daily living; Assistive technology

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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)

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

Study Arms (2)

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.

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.

Device: The MapHabit system (MHS)

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.

Gamified Intervention; Non-gamified Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• MapHabit, Inc.: lead

Study Sites (1)

MapHabit

Atlanta, Georgia, 30308, United States

Location

Related Publications (4)

• 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.

  PMID: 31796718 BACKGROUND

• 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.

  PMID: 34269690 BACKGROUND

• 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.

  PMID: 34334439 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Matt Golden
• Organization: MapHabit

mgolden@maphabit.com

9143301776

Study Officials

• Stuart Zola

  MapHabit, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistical analyses of all data will be carried out independently of investigators by a biostatistical resource department of an academic health center for validation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientific Officer

Model Details: The study will be a randomized controlled clinical trial, in which two conditions will be investigated: a control and experimental condition.

Study Record Dates

• First Submitted: June 7, 2022
• First Posted: June 16, 2022
• Study Start: September 12, 2022
• Primary Completion: December 28, 2023
• Study Completion: December 28, 2023
• Last Updated: September 29, 2025
• Results First Posted: September 29, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Immediately following publication. No end date.
• 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.

Locations

US (1)