- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05422339
Efficacy of Gamification in Enhancing User Engagement
Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- MapHabit
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Collaborators
Investigators
- Principal Investigator: Stuart Zola, MapHabit, Inc.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Gamification Study (NIH PH II)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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