Alzheimer Disease, Assistive Technology, Dementia, Gamification
Conditions
Keywords
Alzheimer disease, Dementia, Caregiver burden, activities of daily living, Assistive technology
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.
Interventions
DEVICEThe MapHabit system (MHS)
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.
Sponsors
MapHabit, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Statistical analyses of all data will be carried out independently of investigators by a biostatistical resource department of an academic health center for validation.
Intervention model description
The study will be a randomized controlled clinical trial, in which two conditions will be investigated: a control and experimental condition.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in User Interaction and Engagement From Baseline to 6 Months | 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. |
| Quality of Life-18 (QoL-18) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 13 |
| 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. | 15 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 17 | 15 |
Baseline characteristics
| Characteristic | Gamified Intervention | Non-gamified Intervention | Total |
|---|---|---|---|
| Age, Customized Age (%) 31-40 years old | 0 Participants | 1 Participants | 1 Participants |
| Age, Customized Age (%) 41-50 years old | 1 Participants | 1 Participants | 2 Participants |
| Age, Customized Age (%) 51-60 years old | 2 Participants | 1 Participants | 3 Participants |
| Age, Customized Age (%) 61-70 years old | 1 Participants | 2 Participants | 3 Participants |
| Age, Customized Age (%) 71-80 years old | 5 Participants | 4 Participants | 9 Participants |
| Age, Customized Age (%) 81-90 years old | 4 Participants | 4 Participants | 8 Participants |
| Age, Customized Age (%) 91-100 years old | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 15 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 7 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 8 Participants | 17 Participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 5 Participants | 7 Participants | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 30 | 0 / 30 |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 1 / 30 | 1 / 30 |
Outcome results
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.
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.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 1 | 32 Uses per Month | Standard Deviation 29.9 |
| Gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 2 | 7 Uses per Month | Standard Deviation 29.3 |
| Gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 3 | 8 Uses per Month | Standard Deviation 21.3 |
| Gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 4 | 5 Uses per Month | Standard Deviation 13.2 |
| Gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 5 | 4 Uses per Month | Standard Deviation 9 |
| Gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 6 | 0 Uses per Month | Standard Deviation 16 |
| Non-gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 5 | 3 Uses per Month | Standard Deviation 38.7 |
| Non-gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 1 | 60 Uses per Month | Standard Deviation 89 |
| Non-gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 4 | 4 Uses per Month | Standard Deviation 45.8 |
| Non-gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 2 | 36 Uses per Month | Standard Deviation 79.2 |
| Non-gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 6 | 4 Uses per Month | Standard Deviation 25.4 |
| Non-gamified Intervention | Change in User Interaction and Engagement From Baseline to 6 Months | Month 3 | 2 Uses per Month | Standard Deviation 39.7 |
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.
Time frame: The instrument was administered to the participants once -- at the end of their participation in the 6 month study.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Gamified Intervention | Quality of Life-18 (QoL-18) | 3.3 score on a scale |
| Non-gamified Intervention | Quality of Life-18 (QoL-18) | 3.6 score on a scale |
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.
Time frame: The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months)
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Gamified Intervention | 2-item Satisfaction Scale (SS-2) | Satisfaction | Score of 7 or above | 6 Participants |
| Gamified Intervention | 2-item Satisfaction Scale (SS-2) | Satisfaction | Score of 6 or below | 7 Participants |
| Gamified Intervention | 2-item Satisfaction Scale (SS-2) | Progress | Score of 7 or above | 7 Participants |
| Gamified Intervention | 2-item Satisfaction Scale (SS-2) | Progress | Score of 6 or below | 6 Participants |
| Non-gamified Intervention | 2-item Satisfaction Scale (SS-2) | Progress | Score of 6 or below | 5 Participants |
| Non-gamified Intervention | 2-item Satisfaction Scale (SS-2) | Satisfaction | Score of 7 or above | 9 Participants |
| Non-gamified Intervention | 2-item Satisfaction Scale (SS-2) | Progress | Score of 7 or above | 10 Participants |
| Non-gamified Intervention | 2-item Satisfaction Scale (SS-2) | Satisfaction | Score of 6 or below | 6 Participants |