Alzheimer Disease, Assistive Technology, Caregiver Burden, Dementia
Conditions
Keywords
Alzheimer's Disease, Dementia, Caregiver Burden, Activities of Daily Living, Assistive Technology, Caregiver Education
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.
Interventions
DEVICEThe MapHabit System
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.
Sponsors
MapHabit, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Statistical analyses of all data will be carried out independently of investigators by a biostatistical resource department of an academic health center for validation.
Intervention model description
The study will be a randomized controlled clinical trial in which two conditions will be investigated: a control and an experimental condition.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Zarit Burden Interview at 6 Months | 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. |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) at 6 Months | 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. |
| Quality of Life - 18 (QoL-18) at 6 Months | 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. |
| Rapid Caregiver Well-Being Scale (R-CWBS) at 6 Months | 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). |
| Caregiver Confidence in Sign/Symptom Management (CCSM) Scale at 6 Months | 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORStuart Zola
MapHabit, Inc.
Participant flow
Recruitment details
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.
Pre-assignment details
No significant events occurred between enrollment and assignment of participants to a group.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous Caregiver | 62.58 Years STANDARD_DEVIATION 11.84 |
| Age, Continuous Care Recipient | 78.92 Years STANDARD_DEVIATION 7.66 |
| Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL) | 74.47 Scores on a scale STANDARD_DEVIATION 28.17 |
| Caregiver Confidence in Sign/Symptom Management (CCSM) scale | 73.00 Scores on a scale STANDARD_DEVIATION 28.14 |
| Ethnicity (NIH/OMB) Caregiver Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Caregiver Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Caregiver Unknown or Not Reported | 0 Participants |
| Ethnicity (NIH/OMB) Care Recipient Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Care Recipient Not Hispanic or Latino | 18 Participants |
| Ethnicity (NIH/OMB) Care Recipient Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregiver American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Caregiver Asian | 1 Participants |
| Race (NIH/OMB) Caregiver Black or African American | 7 Participants |
| Race (NIH/OMB) Caregiver More than one race | 0 Participants |
| Race (NIH/OMB) Caregiver Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Caregiver Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Caregiver White | 25 Participants |
| Race (NIH/OMB) Care Recipient American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Care Recipient Asian | 1 Participants |
| Race (NIH/OMB) Care Recipient Black or African American | 7 Participants |
| Race (NIH/OMB) Care Recipient More than one race | 0 Participants |
| Race (NIH/OMB) Care Recipient Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Care Recipient Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Care Recipient White | 25 Participants |
| Rapid Caregiver Well-Being Scale (R-CWBS) | 21.89 Scores on a scale STANDARD_DEVIATION 5.2 |
| Sex: Female, Male Caregiver Female | 15 Participants |
| Sex: Female, Male Caregiver Male | 3 Participants |
| Sex: Female, Male Care Recipient Female | 7 Participants |
| Sex: Female, Male Care Recipient Male | 18 Participants |
| Zarit Burden Interview | 36.39 Score of Scale STANDARD_DEVIATION 7.94 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 25 | 0 / 25 | 0 / 25 | 1 / 25 |
| other Total, other adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 | 0 / 25 | 0 / 25 | 0 / 25 |
Outcome results
None listed