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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
50
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 through tablets. Depending on the condition, participants will receive a specific version of the application. The experimental condition will receive the version that incorporates gamified structure and the Caregiver Training Program. The MHS is a general wellness product. This functionality is not a regulated medical device.
MapHabit, Inc.
Atlanta, Georgia, United States
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.
Time frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)
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.
Time frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)
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.
Time frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)
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.
Time frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)
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.
Time frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)
Change in Caregiver Self-Assessment Questionnaire from baseline at 6 months
12-item, caregiver self-report measure of stress levels
Time frame: Pre-Post: The instrument will be administered to the participants at baseline, post-intervention (6 months)
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.
Time frame: 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
Time frame: Pre-Post: The assessment will be administered at baseline, post-intervention (6 months)
Generalized Anxiety Disorder (GAD7) Scale
7-item questionnaire used as an initial screening tool for generalized anxiety disorder
Time frame: Pre-Post: The assessment will be administered at baseline, post-intervention (6 months)
Anger Management Scale
12-item questionnaire designed to monitor and evaluate progress in controlling and managing anger
Time frame: Pre-Post: The assessment will be administered at baseline, post-intervention (6 months)
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