Efficacy of Gamification in Enhancing User Engagement

Sponsor
MapHabit, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05422339
Collaborator
Virtuleap (Other)
45
3
9.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: The MapHabit system
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
45 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.The study will be a randomized controlled clinical trial, in which three conditions will be investigated: a control, experimental, and exploratory condition.
Masking:
Double (Participant, 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.
Primary Purpose:
Supportive Care
Official Title:
Efficacy of Gamification in Enhancing User Engagement in Visual Mapping Assistive Technology
Anticipated Study Start Date :
Jul 10, 2022
Anticipated Primary Completion Date :
Mar 15, 2023
Anticipated Study Completion Date :
Apr 15, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gamified Intervention

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.

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.

Active Comparator: Non-gamified Intervention

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.

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.

Other: Exploratory Intervention

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.

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.

Outcome Measures

Primary Outcome Measures

  1. Change in User Interaction and Engagement from baseline at 6 months [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)]

    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.

  2. Change in Margaret Blenkner Research Center (MBRC) Caregiver Strain instrument from baseline at 6 months [Pre-Post: The assessment will be administered at the beginning and end of the study's duration (6-month study).]

    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.

  3. Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months [Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-month study).]

    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.

  4. Quality of Life - 18 (QoL-18) [The instrument will be administered to the participants after the completion of the study duration (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 Outcome Measures

  1. 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 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • MapHabit, Inc.
  • Virtuleap

Investigators

  • Principal Investigator: Stuart Zola, MapHabit, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Stuart Zola, Chief Scientific Officer, MapHabit, Inc.
ClinicalTrials.gov Identifier:
NCT05422339
Other Study ID Numbers:
  • Gamification Study (NIH PH II)
First Posted:
Jun 16, 2022
Last Update Posted:
Jun 16, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stuart Zola, Chief Scientific Officer, MapHabit, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 16, 2022