NCT07054385

I-CARE Rural Pilot: Intervention for Rural-Dwelling Dementia Caregivers

I-CARE-Rural Pilot: Remote Digital Intervention for Rural-Dwelling Dementia Caregivers

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Richard Holden · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Caregiver Burden
• Alzheimer Disease

Interventions

Type	Name	Description
BEHAVIORAL	Brain CareNotes	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	Dementia Guide Expert	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."

Timeline

• Start date: 2025-07-01
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2025-07-08
• Last updated: 2025-11-13

Locations

1 site across 1 country: United States