Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes

NCT05527405 | Completed Results

• 1 other identifier: Fast Track - CTP (NIH-SBIR)
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Alzheimer Disease; Dementia; Caregiver Burden; Assistive Technology

Keywords

Alzheimer's Disease; Dementia; Caregiver Burden; Activities of Daily Living; Assistive Technology; Caregiver Education

Outcome Measures

Primary Outcomes (5)

• Zarit Burden Interview 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.

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

• Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) 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.

  The instrument is administered to the participants at 6 months

• Quality of Life - 18 (QoL-18) 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.

  The instrument is administered to the participants at 6 months

• Rapid Caregiver Well-Being Scale (R-CWBS) 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).

  The instrument is administered to the participants at 6 months

• Caregiver Confidence in Sign/Symptom Management (CCSM) Scale 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.

  The instrument is administered to the participants at 6 months

Study Arms (2)

The MapHabit System + Caregiver Training Program

EXPERIMENTAL

This condition will involve the implementation of an assistive technology software, the MapHabit System (MHS), with an added Caregiver Training Program (CTP) into the caregiver's daily care for their individual 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 caregivers through compatible tablets. CTP will integrate a personalized caregiver education service into MHS, in which participants will engage in training sessions and related educational materials with dementia support coaches.

Device: The MapHabit System

The MapHabit System

ACTIVE COMPARATOR

This control condition will act as the active comparator to the experimental condition. The same assistive technology, the MapHabit System (MHS), will be given to a separate group of participants. The difference here will be that the system will be a version that does not include the caregiver training program.

Device: The MapHabit System

Interventions

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.

The MapHabit System; The MapHabit System + Caregiver Training Program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• MapHabit, Inc.: lead

Study Sites (1)

MapHabit, Inc.

Atlanta, Georgia, 30308, United States

Location

Related Publications (3)

• Boatman F, Golden M, Jin J, Kim Y, Law S, Lu A, Merriam N, Zola S. Assistive technology: Visual mapping combined with mobile software can enhance quality of life and ability to carry out activities of daily living in individuals with impaired memory. Technol Health Care. 2020;28(2):121-128. doi: 10.3233/THC-191980.

  PMID: 31796718 BACKGROUND

• Kelleher J, Zola S, Cui X, Chen S, Gerber C, Parker MW, Davis C, Law S, Golden M, Vaughan CP. Personalized Visual Mapping Assistive Technology to Improve Functional Ability in Persons With Dementia: Feasibility Cohort Study. JMIR Aging. 2021 Oct 19;4(4):e28165. doi: 10.2196/28165.

  PMID: 34269690 BACKGROUND

• Parker MW, Davis C, White K, Johnson D, Golden M, Zola S. Reduced care burden and improved quality of life in African American family caregivers: Positive impact of personalized assistive technology. Technol Health Care. 2022;30(2):379-387. doi: 10.3233/THC-213049.

  PMID: 34334439 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease; Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Matt Golden
• Organization: MapHabit, Inc.

mgolden@maphabit.com

9143301776

Study Officials

• Stuart Zola

  MapHabit, Inc.

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistical analyses of all data will be carried out independently of investigators by a biostatistical resource department of an academic health center for validation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Scientific Officer

Model Details: The study will be a randomized controlled clinical trial in which two conditions will be investigated: a control and an experimental condition.

Study Record Dates

• First Submitted: August 31, 2022
• First Posted: September 2, 2022
• Study Start: August 24, 2024
• Primary Completion: December 15, 2025
• Study Completion: January 8, 2026
• Last Updated: June 10, 2026
• Results First Posted: June 10, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, 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.

Locations

US (1)