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Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05527405
Recruitment Status : Not yet recruiting
First Posted : September 2, 2022
Last Update Posted : April 14, 2023
Sponsor:
Information provided by (Responsible Party):
Stuart Zola, MapHabit, Inc.

Study Description
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Brief Summary:
As part of Phase II of the NIH SBIR grant, the study will conduct a randomized controlled clinical trial in which the MapHabit system (MHS) will offer a caregiver training product that is linked to MHS, an Alzheimer's disease or related dementias (AD/ADRD) assistive technology product that uses visual maps to improve a patient's behavior and sense of autonomy. MapHabit's combined areas of focus, i.e., offer a single integrated product to address the caregiver and the person under this caregiver's care, are unique and will create a new standard in the field to reduce caregiver burden in the setting of caring for individuals with AD/ADRD. Additionally, the study will integrate enhanced user support modules, i.e., gamifying, dashboarding, and social networking, to improve the Caregiver Training Program (CTP) experience.The study will be a randomized controlled clinical trial, in which two conditions will be investigated: 1) control condition in which the MHS alone is incorporated in the participant's daily care and 2) experimental condition in which the MHS+CTP is implemented into the daily care received by participants. The sample size will be a total of 50 patient-caregiver dyads, 25 in each condition. The study duration will be a 6-month intervention.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Caregiver Burden Assistive Technology Device: The MapHabit System Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: The study will be a randomized controlled clinical trial in which two conditions will be investigated: a control and an experimental condition.
Masking: Double (Participant, Outcomes Assessor)
Masking Description: Statistical analyses of all data will be carried out independently of investigators by a biostatistical resource department of an academic health center for validation.
Primary Purpose: Supportive Care
Official Title: Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes in Visual Mapping Assistive Technology
Estimated Study Start Date : July 2023
Estimated Primary Completion Date : August 2025
Estimated Study Completion Date : August 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
 Device: The MapHabit System

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.
 Device: The MapHabit System

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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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

  4. 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


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05527405


Contacts
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Contact: Brittany Montgomery, MS 6786206171 bmontgomery@maphabit.com

Locations
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United States, Georgia
MapHabit, Inc.
Atlanta, Georgia, United States, 30308
Contact: Matt Golden, BBA    914-330-1776    mgolden@maphabit.com   
Principal Investigator: Stuart Zola, PhD         
Sub-Investigator: Brittany Montgomery, MS         
Sponsors and Collaborators
MapHabit, Inc.
Investigators
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Principal Investigator: Stuart Zola MapHabit, Inc.
More Information
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Publications:

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Responsible Party: Stuart Zola, Chief Scientific Officer, MapHabit, Inc.
ClinicalTrials.gov Identifier: NCT05527405    
Other Study ID Numbers: Fast Track - CTP (NIH-SBIR)
First Posted: September 2, 2022    Key Record Dates
Last Update Posted: April 14, 2023
Last Verified: April 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All of the individual participant data collected during the trial, after deidentification.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Immediately following publication. No end date.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Stuart Zola, MapHabit, Inc.:
Alzheimer Disease
Dementia
Caregiver Burden
Activities of Daily Living
Assistive Technology
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Caregiver Burden
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Stress, Psychological
Behavioral Symptoms