Efficacy of Gamification in Enhancing User Engagement

Study Overview
=================
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, in tandem with their respective care partner (i.e., primary familial caregiver). The study will be a randomized controlled clinical trial, in which three conditions will be investigated: 1) experimental condition in which MHS+G is implemented into the daily care received by participants 2) control condition in which the MHS alone is incorporated into the participant's daily care 3) exploratory condition where virtual reality gamification is incorporated into the MHS+G experience. The sample size will be a total of 40 individual-caregiver dyads, 20 in each condition-5 of the 20 subjects in the experimental condition will be included in exploratory condition. The study duration will be a 6-month intervention.

Official Title
-----------------
Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology

Conditions
-----------------
Alzheimer Disease, Dementia, Gamification, Assistive Technology

Intervention / Treatment
-----------------
* Device: The MapHabit system


Participation Criteria
=================
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The study will be a randomized controlled clinical trial, in which three conditions will be investigated: a control, experimental, and exploratory condition.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gamified Intervention<br>This condition will involve the implementation of an assistive technology software (named the MapHabit system) with added gamification features into the daily care of individuals with mild to moderate stage of dementia. 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 application will be made available to families through compatible tablets. | Device: The MapHabit system<br>* 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.<br>|
| Active Comparator: Non-gamified Intervention<br>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. The difference here will be that the software will be a version that does not include gamification features. | Device: The MapHabit system<br>* 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.<br>|
| Other: Exploratory Intervention<br>The exploratory condition will be given the same MHS version as the active comparator (control condition). However, for this group, participants will also engage in virtual reality games throughout the duration of the study. These virtual reality games are integrated with the MHS and includes cognitive games revolving around mental acuity, motor skills, etc. | Device: The MapHabit system<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in User Interaction and Engagement from baseline at 6 months | Our internal analytics of the software can assess the user's interactions with the application, including screen time, number of taps on the screen, number of completed activities, etc. By combining these data points, we can determine the average engagement for each participant and compare them between groups. | Pre-Post: The analytics will be administered at the beginning and end of the study's duration (i.e., assessed at baseline when participant starts to use the app and then again at 6 months study completion) | 
| Change in Margaret Blenkner Research Center (MBRC) Caregiver Strain instrument from baseline at 6 months | 14-item questionnaire assessing the various stresses caregivers experienced related to caring for an individual with cognitive impairment. The total score ranges from 0-42, with a higher score reflecting higher stress and burden on the caregiver. | Pre-Post: The assessment will be administered at the beginning and end of the study's duration (6-month study). | 
| Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months | Assesses an individual with dementia's ability to carry out activities of daily living. The total score ranges from 0-53, with a higher score representing better performance in completing activities of daily living by the individual with dementia. | Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-month study). | 
| 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 will be administered to the participants after the completion of the study duration (6-month study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2-item Satisfaction Scale (SS-2) | Quantifies caregivers' endorsements to two survey questions: How satisfied were they with the MHS? Would they recommend MHS to others? 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia, Alzheimer disease, Caregiver burden, activities of daily living, Assistive technology