Efficacy of Gamification in Enhancing User Engagement

Alzheimer Disease Clinical Trial

Official title:

Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05422339
• Other study ID #: Gamification Study (NIH PH II)
• Status: Completed
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: September 28, 2023

Study information

• Verified date: October 2023
• Source: MapHabit, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: September 28, 2023
• Est. primary completion date: September 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Gamification

Intervention

Device:
• The MapHabit system
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.

Locations

Country	Name	City	State
United States	MapHabit	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
MapHabit, Inc.	Virtuleap

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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).
Primary	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).
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.	The instrument will be administered to the participants after the completion of the study duration (6-month study
Secondary	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)