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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 2-item Satisfaction Scale (SS-2) | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stuart Zola | MapHabit, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MapHabit | Atlanta | Georgia | 30308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31796718 | Background | 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. | |
| 34269690 | Background |
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All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
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.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Baseline characteristics were not collected for caregivers of enrolled participants. As described in pre-assignment details in Result Participant Flow, the current study strictly enrolled persons living with dementia, while being accompanied by their primary caregiver for appropriate support in fully engaging in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Gamified Intervention | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Median | Standard Deviation | Uses per Month | 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. |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Gamified Intervention | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cancer Treatment | General disorders | Non-systematic Assessment | Subject's cancer treatment commitments impeded on full participation in study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt Golden | MapHabit | 9143301776 | mgolden@maphabit.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2024 | Jun 13, 2025 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 14, 2024 | Aug 4, 2025 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
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The study will be a randomized controlled clinical trial, in which two conditions will be investigated: a control and experimental condition.
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Statistical analyses of all data will be carried out independently of investigators by a biostatistical resource department of an academic health center for validation.
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| 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. |
| 34334439 | 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. |
| 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 |
| BG001 | Non-gamified Intervention | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Non-gamified Intervention | 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. |
|
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| Primary | 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. | Posted | Mean | Full Range | score on a scale | The instrument was administered to the participants once -- at the end of their participation in the 6 month study. |
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| Secondary | 2-item Satisfaction Scale (SS-2) | 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. | Posted | Count of Participants | Participants | The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months) |
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|
|
| 1 |
| 30 |
| 1 |
| 30 |
| 0 |
| 30 |
| EG001 | Non-gamified Intervention | 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. | 0 | 30 | 1 | 30 | 0 | 30 |
|
| Seizure | General disorders | Non-systematic Assessment | Subject reported chronic seizures and requested withdrawal from study due to challenges with fully participating in study. |
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| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Progress |
|