Assistive Technology and Reduced Caregiver Burden (ck)

February 22, 2023 updated by: Stuart Zola, MapHabit, Inc.

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • MapHabit, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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)
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.
The instrument was administered to the participants after the completion of the study duration (6-week study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?
The instrument was administered to the participants after the completion of the study duration (6-week study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MapHabit, Inc.

Collaborators

National Institute on Aging (NIA)
CaringKind

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2021

Primary Completion (Actual)

August 15, 2021

Study Completion (Actual)

September 1, 2021

Study Registration Dates

First Submitted

April 25, 2022

First Submitted That Met QC Criteria

April 25, 2022

First Posted (Actual)

April 29, 2022

Study Record Updates

Last Update Posted (Actual)

February 24, 2023

Last Update Submitted That Met QC Criteria

February 22, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CaringKind Study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All of the individual participant data collected during the trial, after deidentification.

IPD Sharing Time Frame

mmediately following publication. No end date.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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