Caregiver Training with MapHabit for Alzheimer's Disease

Overseen By Brittany Montgomery, MS

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: MapHabit, Inc.

Disqualifiers: No ADRD diagnosis, Non-primary caregiver, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on caregiver training and assistive technology, so it's unlikely that medication changes are required.

What data supports the effectiveness of the treatment The MapHabit System for Alzheimer's disease?

Research shows that using visual mapping technology, like The MapHabit System, can help caregivers and people with Alzheimer's disease improve daily activities and reduce caregiver stress. In a study, caregivers using visual maps reported better satisfaction and quality of life compared to those using only educational videos. ^{1 2 3 4 5}

How does the MapHabit System treatment for Alzheimer's differ from other treatments?

The MapHabit System is unique because it uses visual mapping technology on smart devices to help caregivers guide Alzheimer's patients through daily tasks with step-by-step pictures, audio, and videos. This approach not only improves the quality of life for both patients and caregivers but also reduces caregiver burden, unlike traditional treatments that may not focus on daily activity support. ^{4 6 7 8 9}

What is the purpose of this trial?

As part of Phase II of the NIH SBIR grant, the study will conduct a randomized controlled clinical trial in which the MapHabit system (MHS) will offer a caregiver training product that is linked to MHS, an Alzheimer's disease or related dementias (AD/ADRD) assistive technology product that uses visual maps to improve a patient's behavior and sense of autonomy. MapHabit's combined areas of focus, i.e., offer a single integrated product to address the caregiver and the person under this caregiver's care, are unique and will create a new standard in the field to reduce caregiver burden in the setting of caring for individuals with AD/ADRD. Additionally, the study will integrate enhanced user support modules, i.e., gamifying, dashboarding, and social networking, to improve the Caregiver Training Program (CTP) experience.The study will be a randomized controlled clinical trial, in which two conditions will be investigated: 1) control condition in which the MHS alone is incorporated in the participant's daily care and 2) experimental condition in which the MHS+CTP is implemented into the daily care received by participants. The sample size will be a total of 50 patient-caregiver dyads, 25 in each condition. The study duration will be a 6-month intervention.

Research Team

Stuart Zola, PhD

Principal Investigator

MapHabit, Inc.

Eligibility Criteria

This trial is for English-speaking primary caregivers of individuals with mild to moderate Alzheimer's or related dementias. The patient-caregiver pairs will participate in a program aimed at reducing caregiver burden and enhancing the autonomy of the person with dementia.

Inclusion Criteria

Proficient in English

Participating caregiver of individual with dementia must be the primary caregiver

I have been diagnosed with Alzheimer's or similar dementia at a mild to moderate stage.

Exclusion Criteria

I am not fluent in English.

I have not been diagnosed with Alzheimer's or related dementias.

Participating caregiver of individual with dementia is NOT the primary caregiver

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the MapHabit System alone or the MapHabit System with the Caregiver Training Program for 6 months

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Treatment Details

Interventions

• The MapHabit System

Trial Overview The study tests the MapHabit System (MHS), an assistive technology using visual maps, combined with a Caregiver Training Program (CTP). It compares outcomes between those using just MHS and those using MHS+CTP over six months, involving 50 patient-caregiver pairs.

Participant Groups

Group I: Caregiver Training Program Experimental Treatment 1 Intervention

This condition will involve the implementation of an assistive technology software (named the MapHabit System) with an added Caregiver Training Program into the daily care of individuals with mild to moderate stages of Alzheimer's disease and related dementias. The MapHabit System (MHS) is a commercially available visual mapping software application that utilizes 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.

Group II: The MapHabit System Active Control 1 Intervention

This control condition will act 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 the caregiver training program.

Who Is Running the Clinical Trial?

MapHabit, Inc.

Lead Sponsor

Trials

4

Recruited

120+

LiveWell

Collaborator

Trials

1

Recruited

50+

Findings from Research

WeCareAdvisor™ is a web-based platform designed to help families manage dementia-related behavioral symptoms by providing knowledge, daily tips, and tailored treatment plans, and is currently being tested in a randomized trial with 57 caregivers.

The trial aims to assess the platform's acceptability and usability, as well as its immediate impact on caregiver confidence and the frequency of behavioral symptoms, with participants receiving support through check-in calls during the treatment phase.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor™. Gitlin, LN., Kales, HC., Marx, K., et al.[2022]

Recent technological advancements, including digital devices and apps, show promise for improving the diagnosis, management, and treatment of Alzheimer's disease symptoms, based on a review of eight studies published in the last decade.

These technologies can help detect early cognitive deficits, enhance patient responsiveness, and support memory retrieval and spatial cognition, although more randomized controlled trials are needed to validate their effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technological Solutions for Diagnosis, Management and Treatment of Alzheimer's Disease-Related Symptoms: A Structured Review of the Recent Scientific Literature. Cammisuli, DM., Cipriani, G., Castelnuovo, G.[2022]

Verbal-instruction technology significantly helped individuals with mild and moderate Alzheimer's disease perform daily activities, with seven out of nine participants showing accurate performance in tasks like snack preparation and shaving.

The intervention also positively impacted mood, as eight participants exhibited increased happiness or decreased unhappiness during the activities, suggesting that this approach can enhance both activity engagement and emotional well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Persons with mild and moderate Alzheimer's disease use verbal-instruction technology to manage daily activities: effects on performance and mood. Lancioni, G., Singh, N., O'Reilly, M., et al.[2022]

A pictorial instruction program using a portable computer was effective in helping three patients with moderate Alzheimer's disease perform daily activities, achieving high percentages of correct activity steps similar to those seen with more advanced technologies.

In a follow-up study, two patients demonstrated successful indoor travel performance using a basic doorbell system with sound and light cues, with results comparable to those from previous studies using more sophisticated systems, indicating that simpler technologies can still be effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting daily activities and indoor travel of persons with moderate Alzheimer's disease through standard technology resources. Lancioni, GE., Singh, NN., O'Reilly, MF., et al.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Impact of AP@LZ in the daily life of three persons with Alzheimer's disease: long-term use and further exploration of its effectiveness. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of a web-based platform to help families manage dementia-related behavioral symptoms: The WeCareAdvisor™. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Technological Solutions for Diagnosis, Management and Treatment of Alzheimer's Disease-Related Symptoms: A Structured Review of the Recent Scientific Literature. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

A Feasibility Study of Individuals Living at Home with Alzheimer's Disease and Related Dementias: Utilization of Visual Mapping Assistive Technology to Enhance Quality of Life and Reduce Caregiver Burden. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Persons with mild and moderate Alzheimer's disease use verbal-instruction technology to manage daily activities: effects on performance and mood. [2022]

6. Germany pubmed.ncbi.nlm.nih.gov

[Computer-assisted individualized memory training in Alzheimer patients]. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Supporting daily activities and indoor travel of persons with moderate Alzheimer's disease through standard technology resources. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Computer-based cognitive training in Alzheimer's disease patients. [2019]

9. United States pubmed.ncbi.nlm.nih.gov

Persons with mild or moderate Alzheimer's disease use a basic orientation technology to travel to different rooms within a day center. [2015]