Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes

MapHabit

Status: Active, not recruiting

Conditions: Alzheimer Disease; Caregiver Burden; Dementia; Assistive Technology

Treatments: Device: The MapHabit System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05527405

Fast Track - CTP (NIH-SBIR)

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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50 participants in 2 patient groups

Caregiver Training Program

Experimental group

Description:

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.

Treatment:

Device: The MapHabit System

The MapHabit System

Active Comparator group

Description:

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.

Treatment:

Device: The MapHabit System