Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes

Study Overview
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Brief Summary
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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.

Official Title
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Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes in Visual Mapping Assistive Technology

Conditions
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Alzheimer Disease, Dementia, Caregiver Burden, Assistive Technology

Intervention / Treatment
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* Device: The MapHabit System


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Caregiver Training Program<br>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<br>* 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.<br>|
| Active Comparator: The MapHabit System<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in User Interaction and Engagement from baseline at 6 months | 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 | 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 | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer Disease, Dementia, Caregiver Burden, Activities of Daily Living, Assistive Technology