Assistive Technology and Reduced Caregiver Burden

Quality of Life Clinical Trial

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Official title:

Utilizing Assistive Technology to Reduce Caregiver Burden and Enhance Quality of Life in Individuals Living With Alzheimer's Disease and Related Dementias

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05352529
• Other study ID #: CaringKind Study
• Status: Completed
• Phase: N/A
• Start date: February 2, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: February 2023
• Source: MapHabit, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 1, 2021
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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 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.
• 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.

Locations

Country	Name	City	State
United States	MapHabit, Inc.	Atlanta	Georgia

Sponsors (3)

Lead Sponsor	Collaborator
MapHabit, Inc.	CaringKind, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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	2-item Satisfaction Scale (SS-2)	quantified caregivers' endorsements to two survey questions: How satisfied were they with the MHS? Would they recommend MHS to others?	The instrument was administered to the participants after the completion of the study duration (6-week study