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Alzheimer DiseaseNCT05527405

Efficacy of Caregiver Training Program in Enhancing Caregiver and Patient Outcomes

A study testing The MapHabit System in people with Alzheimer Disease and Dementia, run by MapHabit, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Alzheimer Disease, Dementia, Caregiver Burden
What is being tested?
The MapHabit System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteUnited States
Study dates
24 Aug 2024to 8 Jan 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • MapHabit, Inc.

    Atlanta, Georgia, 30308

Other trials in United States

About this study

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

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.

Being tested
The MapHabit System
Keywords
Alzheimer's Disease, Dementia, Caregiver Burden, Activities of Daily Living, Assistive Technology, Caregiver Education
Medical subject headings
Alzheimer Disease, Dementia, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • The MapHabit SystemDevice

    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.

Study groups in NCT05527405
Study groupRoleWhat they receive
The MapHabit System + Caregiver Training ProgramExperimentalThis 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.
Receives: Device: The MapHabit System
The MapHabit SystemActive comparatorThis 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.
Receives: Device: The MapHabit System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: The instrument is administered to the participants at 6 months

  3. 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.

    Measured: The instrument is administered to the participants at 6 months

  4. 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).

    Measured: The instrument is administered to the participants at 6 months

  5. 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.

    Measured: The instrument is administered to the participants at 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2022
  2. Study start24 Aug 2024
  3. Primary completion15 Dec 2025
  4. Study completion8 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Participant, Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05527405
Sponsor's protocol ID
Fast Track - CTP (NIH-SBIR)
Status last verified
May 2026
First submitted
31 Aug 2022
Last updated
10 Jun 2026
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All of the individual participant data collected during the trial, after deidentification.

Publications

  • 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.

    PubMed 31796718

  • 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.

    PubMed 34269690

  • 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.

    PubMed 34334439

Questions about this trial

What is this clinical trial studying?

A study testing The MapHabit System in people with Alzheimer Disease and Dementia, run by MapHabit, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 10 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Zarit Burden Interview at 6 Months (time frame: Pre-Post: The instrument is administered to the participants at 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05527405, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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