Skip to main content
OpenTrials
Completed

NCT Number: NCT05527405

Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes

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 in adjunct. MHS is an Alzheimer's disease or related dementias (ADRD) assistive technology product that uses visual maps to improve the quality of life of persons living with dementia (PLWD) and reduce the burden of care partners. The study will primarily investigate the efficacy of the Caregiver Training Program (CTP), a personalized dementia caregiver education service that is integrated into the MHS product. 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 caregiver's daily care for PLWD and 2) experimental condition in which the MHS+CTP is implemented into the caregiver's daily care for PLWD.

The sample size will be a total of 50 caregiver-PLWD dyads, 25 in each condition. This means the primary participant will be the caregiver, while the PLWD under the caregiver's care is considered the co-participant. Hence, 50 participant dyads enrolled will equate to 100 participants enrolled total. The study will be a 6-month intervention.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Alzheimer Disease Assistive Technology Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Stress, Psychological Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MapHabit, Inc.

Atlanta, Georgia, 30308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participating caregiver of individual with dementia must be the primary caregiver
  • Care recipient must be an individual diagnosed with Alzheimer's disease or other related dementia (ADRD) in their mild to moderate stage of impairment
  • Proficient in English

Exclusion criteria

  • Participating caregiver of individual with dementia is NOT the primary caregiver
  • Care/support recipient not diagnosed with ADRD
  • Not proficient in English

Treatment and study plan

The MapHabit System

Device

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 the Caregiver Training Program (CTP). CTP will integrate a personalized caregiver education service into MHS, in which participants will engage in training sessions and educational materials with dementia support coaches.

Primary outcomes

  1. Zarit Burden Interview at 6 Months

    Time frame: Pre-Post: The instrument is administered to the participants at 6 months

    The instrument consists of 22 items that evaluate the caregiver's perceived emotional, social, and physical burden. Each item is rated on a 5-point Likert scale ranging from 0 (Never) to 4 (Nearly Always). Total scores range from 0 to 88, with higher scores indicating greater caregiver burden. The total score is calculated by summing responses across all items.

  2. Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) at 6 Months

    Time frame: The instrument is administered to the participants at 6 months

    The ADCS-ADL is a validated caregiver-reported measure of functional ability in individuals with dementia. The inventory assesses performance in basic and instrumental activities of daily living through a structured caregiver interview. Higher scores indicate greater functional independence and lower scores indicating greater impairment. The scale consists of 23 items administered via a structured interview with a caregiver or informant. Total scores are calculated by summing item responses, with possible scores ranging from 0 to 78.

  3. Quality of Life - 18 (QoL-18) at 6 Months

    Time frame: The instrument is administered to the participants at 6 months

    18-item quality-of-life questionnaire (QoL-18) evaluated a range of participants' behaviors, including mood, engagement, and memory at the end of the study compared to baseline. The instrument is scored on a Likert Scale, ranging from 1-5. Final score is calculated as sum of all question scores. Minimum score of 18 and maximum score of 90. A higher number indicates better outcome compared to baseline.

  4. Rapid Caregiver Well-Being Scale (R-CWBS) at 6 Months

    Time frame: The instrument is administered to the participants at 6 months

    The Rapid Caregiver Well-being Scale (R-CWBS) consists of 6 items. Each item is rated on a 5-point Likert scale reflecting the caregiver's experiences and perceptions of well-being, with higher scores indicating greater caregiver well-being. Total scores are calculated by summing responses across all items, with higher scores reflecting better overall well-being and lower scores indicating greater caregiver strain or distress. Minimum score: 6 (all items scored 1) Maximum score: 30 (all items scored 5).

  5. Caregiver Confidence in Sign/Symptom Management (CCSM) Scale at 6 Months

    Time frame: The instrument is administered to the participants at 6 months

    The Caregiver Confidence in Sign/Symptom Management (CCSM) scale is a caregiver-reported measure that assesses caregiver confidence in their ability to manage care recipient signs and symptoms. It consists of 25 items, each rated on a 5-point Likert scale ranging from 1 (not at all confident/true) to 5 (extremely confident/true). Total scores are calculated by summing responses across all items, with possible scores ranging from 25 to 125. Higher scores indicate greater caregiver confidence in managing signs and symptoms, whereas lower scores indicate lower confidence.

Sponsors and collaborators

Lead sponsor

MapHabit, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Sep 2, 2022
Registry last updated
Jun 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.