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Efficacy of Gamification in Enhancing User Engagement

Primary Purpose

Alzheimer Disease, Dementia, Gamification

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The MapHabit system
Sponsored by
MapHabit, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimer disease, Dementia, Caregiver burden, activities of daily living, Assistive technology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MapHabit

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Other

Arm Label

Gamified Intervention

Non-gamified Intervention

Exploratory Intervention

Arm Description

This condition will involve the implementation of an assistive technology software (named the MapHabit system) with added gamification features into the daily care of individuals with mild to moderate stage of dementia. 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 application will be made available to families through compatible tablets.

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. The difference here will be that the software will be a version that does not include gamification features.

The exploratory condition will be given the same MHS version as the active comparator (control condition). However, for this group, participants will also engage in virtual reality games throughout the duration of the study. These virtual reality games are integrated with the MHS and includes cognitive games revolving around mental acuity, motor skills, etc.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 7, 2022
Last Updated
October 17, 2023
Sponsor
MapHabit, Inc.
Collaborators
Virtuleap
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1. Study Identification

Unique Protocol Identification Number
NCT05422339
Brief Title
Efficacy of Gamification in Enhancing User Engagement
Official Title
Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
September 12, 2022 (Actual)
Primary Completion Date
September 28, 2023 (Actual)
Study Completion Date
September 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MapHabit, Inc.
Collaborators
Virtuleap

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia, Gamification, Assistive Technology
Keywords
Alzheimer disease, Dementia, Caregiver burden, activities of daily living, Assistive technology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will be a randomized controlled clinical trial, in which three conditions will be investigated: a control, experimental, and exploratory condition.
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Gamified Intervention
Arm Type
Experimental
Arm Description
This condition will involve the implementation of an assistive technology software (named the MapHabit system) with added gamification features into the daily care of individuals with mild to moderate stage of dementia. 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 application will be made available to families through compatible tablets.
Arm Title
Non-gamified Intervention
Arm Type
Active Comparator
Arm Description
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. The difference here will be that the software will be a version that does not include gamification features.
Arm Title
Exploratory Intervention
Arm Type
Other
Arm Description
The exploratory condition will be given the same MHS version as the active comparator (control condition). However, for this group, participants will also engage in virtual reality games throughout the duration of the study. These virtual reality games are integrated with the MHS and includes cognitive games revolving around mental acuity, motor skills, etc.
Intervention Type
Device
Intervention Name(s)
The MapHabit system
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in User Interaction and Engagement from baseline at 6 months
Description
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.
Time Frame
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)
Title
Change in Margaret Blenkner Research Center (MBRC) Caregiver Strain instrument from baseline at 6 months
Description
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.
Time Frame
Pre-Post: The assessment will be administered at the beginning and end of the study's duration (6-month study).
Title
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months
Description
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.
Time Frame
Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-month study).
Title
Quality of Life - 18 (QoL-18)
Description
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 will be administered to the participants after the completion of the study duration (6-month study
Secondary Outcome Measure Information:
Title
2-item Satisfaction Scale (SS-2)
Description
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.
Time Frame
The instrument was administered to the participants after the completion of the study duration ((i.e., assessed at 6 months)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Zola
Organizational Affiliation
MapHabit, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
MapHabit
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All of the individual participant data collected during the trial, after deidentification.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
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.
Citations:
PubMed Identifier
31796718
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.
Results Reference
background
PubMed Identifier
34269690
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.
Results Reference
background
PubMed Identifier
34334439
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.
Results Reference
background

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Efficacy of Gamification in Enhancing User Engagement

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