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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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 BSPD. 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.

Eligibility

Inclusion Criteria:

  • Self-identified primary unpaid rural (RUCA Code of 4-10) caregiver of a person diagnosed with ADRD (at any stage) who are:
  • Receiving primary care and
  • Community-dwelling;
  • English literate;
  • Age ≥ 18 years

Exclusion Criteria:

  • Care recipient is a permanent resident of an extended care facility (nursing home);
  • Involvement in another clinical trial that would prevent or interfere with study objectives;
  • Sensory or other impairment prohibiting the use of a mobile touchscreen device or other study activity (after correction)

Study details
    Caregiver Burden
    Alzheimer&Amp;#39;s Disease

NCT07054385

Richard Holden

14 July 2025

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