Clinical trial NCT05422339: Efficacy of Gamification in Enhancing User Engagement
Official title: Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Dementia
Gamification
Assistive Technology
Keywords: Alzheimer disease
Dementia
Caregiver burden
activities of daily living
Assistive technology
Lead sponsor: MapHabit, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Virtuleap
First posted: 2022-06-16
Enrollment: 32
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will be a randomized controlled clinical trial, in which three conditions will be investigated: a control, experimental, and exploratory condition.
Primary purpose: SUPPORTIVE_CARE

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.


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

Primary outcomes:
measure: Change in User Interaction and Engagement from baseline at 6 months
timeFrame: 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)
measure: Change in Margaret Blenkner Research Center (MBRC) Caregiver Strain instrument from baseline at 6 months
timeFrame: Pre-Post: The assessment will be administered at the beginning and end of the study's duration (6-month study).
measure: Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months
timeFrame: Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-month study).
measure: Quality of Life - 18 (QoL-18)
timeFrame: The instrument will be administered to the participants after the completion of the study duration (6-month study
Secondary outcomes:
measure: 2-item Satisfaction Scale (SS-2)
timeFrame: The instrument was administered to the participants after the completion of the study duration ((i.e., assessed at 6 months)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: MapHabit
state: Georgia
Study officials:
affiliation: MapHabit, Inc.
name: Stuart Zola
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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.