ck: Assistive Technology and Reduced Caregiver Burden

Sponsor
MapHabit, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05352529
Collaborator
CaringKind (Other), National Institute on Aging (NIA) (NIH)
16
1
2
6.9
2.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: The MapHabit system
  • Device: Dementia educational videos
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
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 videosThis 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
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Statistical analyses of all data were carried out independently of investigators by a biostatistical resource department of an academic health center for validation.
Primary Purpose:
Supportive Care
Official Title:
Utilizing Assistive Technology to Reduce Caregiver Burden and Enhance Quality of Life in Individuals Living With Alzheimer's Disease and Related Dementias
Actual Study Start Date :
Feb 2, 2021
Actual Primary Completion Date :
Aug 15, 2021
Actual Study Completion Date :
Sep 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 MapHabit, Inc. Atlanta Georgia United States 30308

Sponsors and Collaborators

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

Investigators

  • Principal Investigator: Stuart Zola, PhD, MapHabit, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Stuart Zola, Chief Scientific Officer, MapHabit, Inc.
ClinicalTrials.gov Identifier:
NCT05352529
Other Study ID Numbers:
  • CARINGKIND
First Posted:
Apr 29, 2022
Last Update Posted:
Apr 29, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Stuart Zola, Chief Scientific Officer, MapHabit, Inc.
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 29, 2022