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Assistive Technology and Reduced Caregiver Burden (ck)

Primary Purpose

Alzheimer Disease, Dementia, Caregiver Burden

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The MapHabit system
Dementia educational videos
Sponsored by
MapHabit, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer Disease focused on measuring Alzheimer disease, Dementia, Caregiver burden, activities of daily living, Assistive technology

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MapHabit, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental condition

Control condition

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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?

Full Information

First Posted
April 25, 2022
Last Updated
February 22, 2023
Sponsor
MapHabit, Inc.
Collaborators
CaringKind, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT05352529
Brief Title
Assistive Technology and Reduced Caregiver Burden
Acronym
ck
Official Title
Utilizing Assistive Technology to Reduce Caregiver Burden and Enhance Quality of Life in Individuals Living With Alzheimer's Disease and Related Dementias
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 2, 2021 (Actual)
Primary Completion Date
August 15, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
MapHabit, Inc.
Collaborators
CaringKind, National Institute on Aging (NIA)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia, Caregiver Burden, Quality of Life, Activities of Daily Living
Keywords
Alzheimer disease, Dementia, Caregiver burden, activities of daily living, Assistive technology

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 videos
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental condition
Arm Type
Experimental
Arm Description
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.
Arm Title
Control condition
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
The MapHabit system
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Dementia educational videos
Intervention Description
Investigators collected publicly available educational videos regarding dementia-related caregiving and support. The videos were made available to participants through compatible tablets.
Primary Outcome Measure Information:
Title
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 weeks
Description
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.
Time Frame
Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-week study).
Title
Change in Margaret Blenkner Research Center (MBRC) Caregiver Strain instrument from baseline at 6 weeks
Description
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.
Time Frame
Pre-Post: The assessment was administered at the beginning and end of the study's duration (6-week study).
Title
Quality of Life - 18 (QoL-18)
Description
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.
Time Frame
The instrument was administered to the participants after the completion of the study duration (6-week study
Secondary Outcome Measure Information:
Title
2-item Satisfaction Scale (SS-2)
Description
quantified caregivers' endorsements to two survey questions: How satisfied were they with the MHS? Would they recommend MHS to others?
Time Frame
The instrument was administered to the participants after the completion of the study duration (6-week study

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stuart Zola, PhD
Organizational Affiliation
MapHabit, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
MapHabit, Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
Citations:
PubMed Identifier
31796718
Citation
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.
Results Reference
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PubMed Identifier
34269690
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.
Results Reference
background
PubMed Identifier
34334439
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.
Results Reference
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Assistive Technology and Reduced Caregiver Burden

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