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Completed

NCT Number: NCT05352529

Assistive Technology and Reduced Caregiver Burden

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.

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Key information

Conditions

Alzheimer Disease Activities of Daily Living Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Quality of Life Stress, Psychological Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MapHabit, Inc.

Atlanta, Georgia, 30308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

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

    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.

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

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

    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.

  3. Quality of Life - 18 (QoL-18)

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

    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.

Secondary outcomes

  1. 2-item Satisfaction Scale (SS-2)

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

    quantified caregivers' endorsements to two survey questions: How satisfied were they with the MHS? Would they recommend MHS to others?

Sponsors and collaborators

Lead sponsor

MapHabit, Inc.

Industry

Collaborators

  • CaringKind
  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: ck

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 29, 2022
Registry last updated
Feb 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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