- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05527405
Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes
Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes in Visual Mapping Assistive Technology
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Brittany Montgomery, MS
- Phone Number: 6786206171
- Email: bmontgomery@maphabit.com
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30308
- MapHabit, Inc.
-
Contact:
- Matt Golden, BBA
- Phone Number: 914-330-1776
- Email: mgolden@maphabit.com
-
Principal Investigator:
- Stuart Zola, PhD
-
Sub-Investigator:
- Brittany Montgomery, MS
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment
- 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
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: Caregiver Training Program
This condition will involve the implementation of an assistive technology software (named the MapHabit System) with an added Caregiver Training Program into the daily care of individuals with mild to moderate stages of Alzheimer's disease and related dementias.
The MapHabit System (MHS) is a commercially available visual mapping software application that utilizes 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 will be made available to families through compatible tablets.
|
The MapHabit System (MHS) is a commercially available visual mapping software application that utilizes 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 will be made available to families through compatible smartphones and tablets. Depending on the condition, participants will receive a specific version of the application. The experimental condition will receive the version that incorporates gamified content and structure. 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: The MapHabit System
This control condition will act as the active comparator to the experimental condition.
The same assistive technology, the MapHabit System, will be given to a separate group of participants.
The difference here will be that the software will be a version that does not include the caregiver training program.
|
The MapHabit System (MHS) is a commercially available visual mapping software application that utilizes 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 will be made available to families through compatible smartphones and tablets. Depending on the condition, participants will receive a specific version of the application. The experimental condition will receive the version that incorporates gamified content and structure. 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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in User Interaction and Engagement from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up..
|
18-item quality-of-life questionnaire (QoL-18) evaluates 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 1-10.
A higher number indicates better outcome.
|
Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up..
|
Change in Zarit Burden Assessment Caregiver Strain instrument from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
18-item questionnaire assessing the various stresses caregivers experienced relating to caring for an individual with cognitive impairment.
The total score ranges from 0-72, with a higher score reflecting higher stress and burden on the caregiver.
|
Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
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 instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
Change in Quality of Life - 18 (QoL-18) from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the middle and end of the study compared to before the use of the MHS.
The instrument is scored on a Likert Scale, ranging from 1-10.
A higher number indicates better outcome.
|
Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
Change in Brief Quality of Life - 8 (QoL-8) from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
8-items selected from the Wisconsin Quality of Life Caregiver Questionnaire evaluated a range of participants' behaviors, including mood, engagement, and memory at the middle and end of the study compared to before the use of the MHS.
The instrument is scored on a Likert Scale, ranging from 1-10.
A higher number indicates better outcome.
|
Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
Change in Caregiver Self-Assessment Questionnaire from baseline at 6 months
Time Frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
12-item, caregiver self-report measure of stress levels
|
Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
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 (i.e., assessed at 6 months)
|
Quantifies caregivers' endorsements to two survey questions: How satisfied were they with the MHS? Would they recommend MHS to others?
Both questions are scored on a 10-point scale, with a higher value reflecting a better outcome/experience.
|
The instrument was administered to the participants after the completion of the study duration (i.e., assessed at 6 months)
|
Pain and Sleep Questionnaire
Time Frame: Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
5-item questionnaire developed to assess the impact of pain on quality of sleep
|
Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
Generalized Anxiety Disorder (GAD7) Scale
Time Frame: Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
7-item questionnaire used as an initial screening tool for generalized anxiety disorder
|
Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
Anger Management Scale
Time Frame: Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
12-item questionnaire designed to monitor and evaluate progress in controlling and managing anger
|
Pre-Post: The assessment will be administered at baseline, post-intervention (6 months), and at the 3-month follow-up.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Stuart Zola, MapHabit, Inc.
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Fast Track - CTP (NIH-SBIR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
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
Studies a U.S. FDA-regulated device product
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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