Assistive Technology and Reduced Caregiver Burden

NCT ID: NCT05352529

Last Updated: 2023-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-02

Study Completion Date

2021-09-01

Brief Summary

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The study investigated a six-week randomized controlled trial study in a small cohort of 16 family caregivers of individuals living with Alzheimer's disease and related dementias. Family caregivers used assistive technology in the form of visual mapping software on smart devices in the experimental condition to support their care recipients in carrying out activities of daily living. Family caregivers in the control condition viewed educational videos about dementia care on their devices in supporting their individuals. The intervention was implemented for a total of 6 weeks. The investigators hypothesized that compared to the caregivers using educational videos, the caregivers using assistive technology will report improved quality of life and completion of activities of daily living for their care recipients, all the while reducing caregiver's burden and stress.

Detailed Description

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Conditions

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Alzheimer Disease Dementia Caregiver Burden Quality of Life Activities of Daily Living

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This randomized controlled trial assigned participants to two conditions: the experimental condition that implemented the assistive technology intervention and the control condition that implemented educational videos
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors
Statistical analyses of all data were carried out independently of investigators by a biostatistical resource department of an academic health center for validation.

Study Groups

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Experimental condition

This condition implemented the assistive technology in question: the MapHabit System (MHS). 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 was made available to families through compatible tablets.

Group Type EXPERIMENTAL

The MapHabit system

Intervention Type DEVICE

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 was made available to families through compatible smartphones and tablets.

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.

Control condition

The control condition acted as the active comparator to the experimental condition. This condition implemented educational videos focused on Alzheimer's disease, dementia care, and caregiver support. The videos were made available to caregivers through compatible tablets.

Group Type ACTIVE_COMPARATOR

Dementia educational videos

Intervention Type DEVICE

Investigators collected publicly available educational videos regarding dementia-related caregiving and support. The videos were made available to participants through compatible tablets.

Interventions

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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 was made available to families through compatible smartphones and tablets.

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.

Intervention Type DEVICE

Dementia educational videos

Investigators collected publicly available educational videos regarding dementia-related caregiving and support. The videos were made available to participants through compatible tablets.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Individual diagnosed with Alzheimer's disease or other related dementia (ADRD)
* 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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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CaringKind

UNKNOWN

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

MapHabit, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Stuart Zola

Chief Scientific Officer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stuart Zola, PhD

Role: PRINCIPAL_INVESTIGATOR

MapHabit, Inc.

Locations

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MapHabit, Inc.

Atlanta, Georgia, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31796718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34269690 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34334439 (View on PubMed)

Other Identifiers

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CaringKind Study

Identifier Type: -

Identifier Source: org_study_id

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