Trial Outcomes & Findings for Efficacy of Gamification in Enhancing User Engagement (NCT NCT05422339)
NCT ID: NCT05422339
Last Updated: 2025-09-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
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.
Results posted on
2025-09-29
Participant Flow
60 participants were targeted in order to account for expected enrollment attrition. The 60 participant enrollment include only the persons living with dementia (PLWD). Each participant was accompanied by their primary caregiver in order to receive necessary assistance in fully engaging in the study. All enrollment numbers, data, and outcomes reflect the 60 PLWD only, and do not include their accompanied caregivers. The subjects were randomly assigned to one of two groups.
Participant milestones
| Measure |
Gamified Intervention
Participants were persons with mild/moderate stage of ADRD. Each participant were enrolled with the presence of their primary care partner, who was required in the assistance of the engagement of the intervention and completion of assessments throughout the study. Only the participant's tracked and self-reported data contributed to data collection. Accompanying care partners needed to be in a direct care partner relationship with the participant, defined as a care partner who spends at least eight hours per week with the participant. 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 application was made available through tablets. 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.
|
Non-gamified Intervention
Each participant enrolled together with their primary care partner in the same fashion described in the Gamified Intervention arm. This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, was given to individuals with mild to moderate ADRD and their caregivers. The difference here was that the software was a version that did 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.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
30
|
|
Overall Study
COMPLETED
|
13
|
15
|
|
Overall Study
NOT COMPLETED
|
17
|
15
|
Reasons for withdrawal
| Measure |
Gamified Intervention
Participants were persons with mild/moderate stage of ADRD. Each participant were enrolled with the presence of their primary care partner, who was required in the assistance of the engagement of the intervention and completion of assessments throughout the study. Only the participant's tracked and self-reported data contributed to data collection. Accompanying care partners needed to be in a direct care partner relationship with the participant, defined as a care partner who spends at least eight hours per week with the participant. 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 application was made available through tablets. 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.
|
Non-gamified Intervention
Each participant enrolled together with their primary care partner in the same fashion described in the Gamified Intervention arm. This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, was given to individuals with mild to moderate ADRD and their caregivers. The difference here was that the software was a version that did 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
15
|
Baseline Characteristics
Efficacy of Gamification in Enhancing User Engagement
Baseline characteristics by cohort
| Measure |
Gamified Intervention
n=13 Participants
Participants were persons with mild/moderate stage of Alzheimer's disease and related dementias (ADRD). Each participant was enrolled with the presence of their primary care partner, who was required for assistance in the engagement of the intervention and completion of assessments throughout the study. Only participants directly contributed to data collection. Accompanying care partners needed to be in a direct care partner relationship with the participant, defined as a care partner who spends at least eight hours per week with the participant. 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.
|
Non-gamified Intervention
n=15 Participants
Each participant enrolled together with their primary care partner in the same fashion described in Gamified Intervention. This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, was given to individuals with mild to moderate ADRD and their caregivers. The difference here was that the software was a version that did 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.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Age (%) · 31-40 years old
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Customized
Age (%) · 41-50 years old
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
Age (%) · 51-60 years old
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
Age (%) · 61-70 years old
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
Age (%) · 71-80 years old
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Customized
Age (%) · 81-90 years old
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Age, Customized
Age (%) · 91-100 years old
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
13 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Gamified Intervention
n=13 Participants
Participants were persons with mild/moderate stage of Alzheimer's disease and related dementias (ADRD). Each participant was enrolled with the presence of their primary care partner, who assisted in the engagement of the intervention and completion of assessments throughout the study. Only participants directly contributed to data collection. Accompanying care partners needed to be in a direct care partner relationship with the participant, defined as a care partner who spends at least eight hours per week with the participant. 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.
|
Non-gamified Intervention
n=15 Participants
Each participant enrolled together with their primary care partner in the same fashion described in Gamified Intervention. This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, was given to individuals with mild to moderate ADRD and their caregivers. The difference here was that the software was a version that did 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.
|
|---|---|---|
|
Change in User Interaction and Engagement From Baseline to 6 Months
Month 2
|
7 Uses per Month
Standard Deviation 29.3
|
36 Uses per Month
Standard Deviation 79.2
|
|
Change in User Interaction and Engagement From Baseline to 6 Months
Month 6
|
0 Uses per Month
Standard Deviation 16.0
|
4 Uses per Month
Standard Deviation 25.4
|
|
Change in User Interaction and Engagement From Baseline to 6 Months
Month 1
|
32 Uses per Month
Standard Deviation 29.9
|
60 Uses per Month
Standard Deviation 89.0
|
|
Change in User Interaction and Engagement From Baseline to 6 Months
Month 3
|
8 Uses per Month
Standard Deviation 21.3
|
2 Uses per Month
Standard Deviation 39.7
|
|
Change in User Interaction and Engagement From Baseline to 6 Months
Month 4
|
5 Uses per Month
Standard Deviation 13.2
|
4 Uses per Month
Standard Deviation 45.8
|
|
Change in User Interaction and Engagement From Baseline to 6 Months
Month 5
|
4 Uses per Month
Standard Deviation 9.0
|
3 Uses per Month
Standard Deviation 38.7
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Gamified Intervention
n=13 Participants
Participants were persons with mild/moderate stage of Alzheimer's disease and related dementias (ADRD). Each participant was enrolled with the presence of their primary care partner, who assisted in the engagement of the intervention and completion of assessments throughout the study. Only participants directly contributed to data collection. Accompanying care partners needed to be in a direct care partner relationship with the participant, defined as a care partner who spends at least eight hours per week with the participant. 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.
|
Non-gamified Intervention
n=15 Participants
Each participant enrolled together with their primary care partner in the same fashion described in Gamified Intervention. This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, was given to individuals with mild to moderate ADRD and their caregivers. The difference here was that the software was a version that did 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.
|
|---|---|---|
|
Quality of Life-18 (QoL-18)
|
3.3 score on a scale
Interval 1.0 to 5.0
|
3.6 score on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Gamified Intervention
n=13 Participants
Participants were persons with mild/moderate stage of Alzheimer's disease and related dementias (ADRD). Each participant was enrolled with the presence of their primary care partner, who assisted in the engagement of the intervention and completion of assessments throughout the study. Only participants directly contributed to data collection. Accompanying care partners needed to be in a direct care partner relationship with the participant, defined as a care partner who spends at least eight hours per week with the participant. 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.
|
Non-gamified Intervention
n=15 Participants
Each participant enrolled together with their primary care partner in the same fashion described in Gamified Intervention. This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, was given to individuals with mild to moderate ADRD and their caregivers. The difference here was that the software was a version that did 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.
|
|---|---|---|
|
2-item Satisfaction Scale (SS-2)
Satisfaction · Score of 7 or above
|
6 Participants
|
9 Participants
|
|
2-item Satisfaction Scale (SS-2)
Satisfaction · Score of 6 or below
|
7 Participants
|
6 Participants
|
|
2-item Satisfaction Scale (SS-2)
Progress · Score of 7 or above
|
7 Participants
|
10 Participants
|
|
2-item Satisfaction Scale (SS-2)
Progress · Score of 6 or below
|
6 Participants
|
5 Participants
|
Adverse Events
Gamified Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Non-gamified Intervention
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gamified Intervention
n=30 participants at risk
Participants were persons with mild/moderate stage of Alzheimer's disease and related dementias (ADRD). Each participant was enrolled with the presence of their primary care partner, who assisted in the engagement of the intervention and completion of assessments throughout the study. Only participants directly contributed to data collection. Accompanying care partners needed to be in a direct care partner relationship with the participant, defined as a care partner who spends at least eight hours per week with the participant. 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.
|
Non-gamified Intervention
n=30 participants at risk
Each participant enrolled together with their primary care partner in the same fashion described in Gamified Intervention. This control condition acted as the active comparator to the experimental condition. The same assistive technology, the MapHabit system, was given to individuals with mild to moderate ADRD and their caregivers. The difference here was that the software was a version that did 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.
|
|---|---|---|
|
General disorders
Cancer Treatment
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected over the duration of the study (6 months)
As elaborated in Participant result flow and pre-assignment details, the current study's participant enrollment (and subsequently all reported baseline characteristics, data, and outcomes) only represent the 60 persons living with dementia and do not include nor reflect their respective primary caregivers who assisted in the participant's completion of the study. Following this, adverse event reporting reflect any events that may have occurred that relate to the person living with dementia.
|
0.00%
0/30 • Adverse event data was collected over the duration of the study (6 months)
As elaborated in Participant result flow and pre-assignment details, the current study's participant enrollment (and subsequently all reported baseline characteristics, data, and outcomes) only represent the 60 persons living with dementia and do not include nor reflect their respective primary caregivers who assisted in the participant's completion of the study. Following this, adverse event reporting reflect any events that may have occurred that relate to the person living with dementia.
|
|
General disorders
Seizure
|
0.00%
0/30 • Adverse event data was collected over the duration of the study (6 months)
As elaborated in Participant result flow and pre-assignment details, the current study's participant enrollment (and subsequently all reported baseline characteristics, data, and outcomes) only represent the 60 persons living with dementia and do not include nor reflect their respective primary caregivers who assisted in the participant's completion of the study. Following this, adverse event reporting reflect any events that may have occurred that relate to the person living with dementia.
|
3.3%
1/30 • Number of events 1 • Adverse event data was collected over the duration of the study (6 months)
As elaborated in Participant result flow and pre-assignment details, the current study's participant enrollment (and subsequently all reported baseline characteristics, data, and outcomes) only represent the 60 persons living with dementia and do not include nor reflect their respective primary caregivers who assisted in the participant's completion of the study. Following this, adverse event reporting reflect any events that may have occurred that relate to the person living with dementia.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place