Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Stuart Zola | MapHabit, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MapHabit, Inc. | Atlanta | Georgia | 30308 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31796718 | Background | 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. | |
| 34269690 | Background |
Not provided
Not provided
All of the individual participant data collected during the trial, after deidentification.
Immediately following publication. No end date.
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.
Not provided
No significant events occurred between enrollment and assignment of participants to a group.
Participants were enrolled as caregiver-care recipient dyads. Each dyad consisted of one caregiver and one person living with dementia. Dyads were enrolled and randomized as a single unit. A total of 50 dyads (participants) were enrolled and randomized. They were recruited through study flyers, dementia-related conferences, and dementia care organizations. Interested dyads contacted the study team and were screened for eligibility. Participation duration for each participant dyad was 6 months.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | The MapHabit System + Caregiver Training Program | 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 caregivers will engage in training sessions and related program materials with dementia support coaches, while the person living with dementia will interact with the software for ADLs. |
| FG001 | The MapHabit System | 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. Caregivers will be interacting with the MHS with their person living with dementia. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | The MapHabit System + Caregiver Training Program | 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 program materials with dementia support coaches. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Data is organized to report age of the caregiver and respective care recipient separately in a given dyad. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Posted | Mean | Standard Deviation | Score | Pre-Post: The instrument is administered to the participants at 6 months |
|
from enrollment until end of study participation, up to 6 months
Systematic assessment of participants using questionnaires.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | The MapHabit System + Caregiver Training Program - Caregiver | 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. Primary caregiver of a given dyad only. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt Golden | MapHabit, Inc. | 9143301776 | mgolden@maphabit.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 9, 2024 | Feb 24, 2026 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 26, 2025 | Feb 24, 2026 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D003704 | Dementia |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
Not provided
Not provided
The study will be a randomized controlled clinical trial in which two conditions will be investigated: a control and an experimental condition.
Not provided
Not provided
Statistical analyses of all data will be carried out independently of investigators by a biostatistical resource department of an academic health center for validation.
|
| 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 |
| 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. |
| 34334439 | 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. |
| BG001 | The MapHabit System | 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. |
| BG002 | Total | Total of all reporting groups |
For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. |
| Mean |
| Standard Deviation |
| Years |
|
| Sex: Female, Male | Data is organized to report sex of the caregiver and respective care recipient separately in a given dyad. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Data is organized to report race of the caregiver and respective care recipient separately in a given dyad. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Data is organized to report ethnicity of the caregiver and respective care recipient separately in a given dyad. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Count of Participants | Participants |
|
| Zarit Burden Interview | 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. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Mean | Standard Deviation | Score of Scale |
|
| Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) | 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. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Mean | Standard Deviation | Scores on a scale |
|
| Rapid Caregiver Well-Being Scale (R-CWBS) | 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). | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Mean | Standard Deviation | Scores on a scale |
|
| Caregiver Confidence in Sign/Symptom Management (CCSM) scale | 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. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Mean | Standard Deviation | Scores on a scale |
|
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.
| OG001 | The MapHabit System | 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. |
|
|
| Primary | 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. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Posted | Mean | Standard Deviation | Score | The instrument is administered to the participants at 6 months |
|
|
|
| Primary | 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. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Posted | Mean | Standard Deviation | Score | The instrument is administered to the participants at 6 months |
|
|
|
| Primary | 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). | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Posted | Mean | Standard Deviation | score | The instrument is administered to the participants at 6 months |
|
|
|
| Primary | 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. | For analysis of baseline and final outcomes, number of participants analyzed reflect participants who fully completed the study in order to adhere to the study's primary objective in assessing pre-post differences in outcomes. Differences in numbers between groups are explained by participant withdrawal, lost to follow ups, etc. | Posted | Mean | Standard Deviation | Score | The instrument is administered to the participants at 6 months |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | The MapHabit System + Caregiver Training Program - Care Recipient | 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. The care recipient of a given dyad only. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG002 | The MapHabit System - Caregiver | 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. Primary caregiver of a given dyad only. | 0 | 25 | 0 | 25 | 0 | 25 |
| EG003 | The MapHabit System - Care Recipient | 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. The care recipient of a given dyad only. | 1 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
Not provided
| D019636 |
| Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| Male |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Unknown or Not Reported |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|