Assistive Technology and Reduced Caregiver Burden

NCT05352529 | Completed

• 1 other identifier: CaringKind Study
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Alzheimer disease; Dementia; Caregiver burden; activities of daily living; Assistive technology

Outcome Measures

Primary Outcomes (3)

• Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 weeks

  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.

  Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-week study).

• Change in Margaret Blenkner Research Center (MBRC) Caregiver Strain instrument from baseline at 6 weeks

  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.

  Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-week study).

• 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.

  The instrument was administered to the participants after the completion of the study duration (6-week study

Secondary Outcomes (1)

• 2-item Satisfaction Scale (SS-2)

  The instrument was administered to the participants after the completion of the study duration (6-week study

Study Arms (2)

Experimental condition

EXPERIMENTAL

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.

Device: The MapHabit system

Control condition

ACTIVE COMPARATOR

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.

Device: Dementia educational videos

Interventions

The MapHabit system 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.

Experimental condition

Dementia educational videos DEVICE

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

Control condition

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Individual not diagnosed with ADRD
• Participating caregiver of individual with dementia is NOT the primary caregiver
• Not proficient in English

Sponsors & Collaborators

• MapHabit, Inc.: lead
• CaringKind: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

MapHabit, Inc.

Atlanta, Georgia, 30308, United States

Location

Related Publications (3)

• 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.

  PMID: 31796718 BACKGROUND

• 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.

  PMID: 34269690 BACKGROUND

• 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.

  PMID: 34334439 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Stuart Zola, PhD

  MapHabit, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistical analyses of all data were carried out independently of investigators by a biostatistical resource department of an academic health center for validation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientific Officer

Model Details: 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

Study Record Dates

• First Submitted: April 25, 2022
• First Posted: April 29, 2022
• Study Start: February 2, 2021
• Primary Completion: August 15, 2021
• Study Completion: September 1, 2021
• Last Updated: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: mmediately following publication. No end date.
• 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.

Locations

US (1)