An interventional study of Brain CareNotes and Dementia Guide Expert in Caregiver Burden and Alzheimer Disease, sponsored by Richard Holden. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Richard Holden · Not applicable, Interventional, and Supportive care
The purpose of this study is to assess feasibility and to estimate efficacy of our app "Brain CareNotes" for dementia caregivers who reside in a rural setting (as defined by RUCA codes 4 through 10). The Brain CareNotes app is designed to reduce informal caregiver burden of those caring for individuals with Alzheimer's disease and related dementias (ADRD) and behavioral and psychological symptoms of dementia (BPSD) of individuals with ADRD. The study will enroll up to 60 rural caregivers of community-dwelling individuals living with ADRD. Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for six months, with usage reminders.
This study will evaluate the feasibility and estimate the effect of Brain CareNotes on caregiver burden and patient BPSD. The study will enroll up to 60 rural-dwelling caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for six months.
The primary objective is to evaluate the feasibility of Brain CareNotes, as assessed by caregiver-reported a) usability, as assessed by the 10-item Simplified System Usability Scale and b) acceptance as assessed by the 4-item Behavioral Intention questionnaire.
The secondary objective is to estimate the effect of Brain CareNotes on a) caregiver burden and b) patient BPSD at six months, compared to attention control. These outcomes are calculated using the caregiver-reported Neuropsychiatric Inventory (NPI): the NPI caregiver distress sub-score measures caregiver burden and the NPI total score measures patient BPSD. The investigators will obtain NPI responses from caregivers at baseline, three, and six months.
Exploratory objectives are to estimate the effect of Brain CareNotes on a) caregiver depressive symptoms and b) patient and caregiver acute care utilization at six months; and to examine early effects at three months on c) the usability and acceptance of Brain CareNotes, and d) caregiver burden and BPSD. Caregiver depressive symptoms will be assessed by the Patient Health Questionnaire-9 (PHQ-9), administered at baseline, three, and six months. Acute care utilization data will be obtained from self-reports to identify both caregivers' and patients' hospital and emergency visits that occurred within six months of enrollment.
422 studies on the registry are indexed under Caregiver Burden; 151 are open to participants now.
This study's enrollment of 41 is below the median of 73 across 330 interventional studies indexed under Caregiver Burden.
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Exclusion Criteria:
The Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities.
Behavioral: Brain CareNotes
Dementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services."
Behavioral: Dementia Guide Expert
The Brain CareNotes mobile telehealth app is used by unpaid caregivers for BPSD management. It includes remote communication with an external human support person-a care coach-as well as features for users to independently perform health-related activities.
Dementia Guide Expert provides education only and no interactive BPSD management support, coaching, assessment, or external response. It contains "evidence-based expert information on what dementia is, types, contributing factors, risks, symptoms, stages, diagnosis, tests, treatment, management, communication techniques, and links to resources and support services."
App Usability
10-item standardized survey of user-reported technology usability, based on revised System Usability Scale, with scale score computed ranging from 0-100, with 100 indicating highest possible perceived usability.
Time frame: Six Months
App Acceptability
A 4-item questionnaire assessing a user's intention to use a technology in the near future. Scores range from 0-24 with a high score representing greater intention to use the technology.
Time frame: Six Months
Patient BPSD
Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI). The NPI is a 12-item questionnaire. The total score is calculated by adding the product of the frequency and severity of those 12 items. A score of 0 would indicate that no symptoms are present while a score of 144 would indicate that all symptoms are present at the highest level of frequency and severity.
Time frame: Six Months
Caregiver Burden
The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score. The distress score is calculated by adding the distress score for each of the 12 items of the NPI. A score of 0 would indicate that the BPSD cause no distress while a score of 60 would indicate that each symptom causes severe distress for the caregiver.
Time frame: Six Months
Caregiver Depressive Symptoms
Caregiver depression as measured by the Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 9-item questionnaire using a 0-3 rating scale. Scores range from 0-27. A total score of 0 represents no depression, while score of 5, 10, 15, and 20 serve as cut points for mild, moderate, moderately severe, and severe depression, respectively.
Time frame: Six Months
Patient Acute Care Utilization
Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports.
Time frame: Six Months
Caregiver Acute Care Utilization
Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports.
Time frame: Six Months
Caregiver Self-Efficacy
Caregiver perceived self-efficacy as measured using the Revised Scale for Caregiving Self-Efficacy. It consists of 3 sections each with five items. Participants rank self-efficacy on a scale of 0-100 for each item, with a higher score representing greater confidence. Thus, a high total score represents greater self-efficacy.
Time frame: Six Months
Caregiver Social Support
Caregiver perceived social support measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item questionnaire using a 7-point Likert scale where 1 is very strongly disagree and 7 is very strongly agree. Scores range from 12-84. A low score represents minimal social support while a high score represents a great level of perceived social support.
Time frame: Six Months
App Use
Usage logs of app use over time.
Time frame: Six Months
Plan to share: No
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This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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