Gamified Intervention for Dementia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Dementia+3 MoreThe MapHabit system - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Dementia
  • Alzheimer's Disease
  • Assistive Technology
  • Gamification

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

4 Primary · 1 Secondary · Reporting Duration: Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-month study).

Month 6
Change in User Interaction and Engagement from baseline at 6 months
Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-month study).
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 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).
Change in Margaret Blenkner Research Center (MBRC) Caregiver Strain instrument from baseline at 6 months
Month 6
2-item Satisfaction Scale (SS-2)
The instrument will be administered to the participants after the completion of the study duration (6-month study
Quality of Life - 18 (QoL-18)

Trial Safety

Trial Design

2 Treatment Groups

Non-gamified Intervention
1 of 2
Gamified Intervention
1 of 2

Active Control

Experimental Treatment

45 Total Participants · 2 Treatment Groups

Primary Treatment: Gamified Intervention · No Placebo Group · N/A

Gamified Intervention
Device
Experimental Group · 1 Intervention: The MapHabit system · Intervention Types: Device
Non-gamified Intervention
Device
ActiveComparator Group · 1 Intervention: The MapHabit system · Intervention Types: Device
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
The MapHabit system
2021
N/A
~20

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: pre-post: the assessment was administered at the beginning and end of the study's duration (6-month study).

Who is running the clinical trial?

MapHabit, Inc.Lead Sponsor
3 Previous Clinical Trials
92 Total Patients Enrolled
2 Trials studying Dementia
66 Patients Enrolled for Dementia
VirtuleapUNKNOWN
Stuart ZolaPrincipal InvestigatorMapHabit, Inc.
1 Previous Clinical Trials
50 Total Patients Enrolled
1 Trials studying Dementia
50 Patients Enrolled for Dementia

Eligibility Criteria

Age Any Age · All Participants · 3 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be able to communicate in English.
You have a diagnosis of Alzheimer's disease or other related dementia (ADRD) in your mild to moderate stage of impairment.