Alzheimer Disease / Caregiver Burden / Dementia Guide Expert · Interventional Study

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

ClinicalTrials.gov · August 17, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed pilot randomized trial of a mobile app intervention (Brain CareNotes) versus education-only control in rural dementia caregivers, designed to assess feasibility and acceptability over six months. Results have not been posted in this registry record as of the reporting date. The study is too early-phase and underpowered to support clinical decision-making.

What was studied

Interventional, Randomized, Parallel, Triple masking, Supportive Care purpose. Caregiver Burden, Alzheimer Disease; age from 18 Years. Intervention: Brain CareNotes App. Compared with: Attention Control App — Active Comparator. n = 41. 1 site: United States.

Key findings

Safety

No demographic, baseline characteristics, or adverse event data reported in registry record

Who this may help

This pilot study provides no clinical outcome data and is not intended to demonstrate efficacy. Results, when available, will inform the design of larger trials but do not currently support any change in caregiver support practices.

Plain-language summary

This is a completed pilot feasibility and acceptability study of a behavioral intervention (mobile app) in rural dementia caregivers, with no results posted in the registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: App Usability (assessed at Six Months); App Acceptability (assessed at Six Months)

DesignInterventional, Randomized, Parallel, Triple masking, Supportive Care purpose

PopulationCaregiver Burden, Alzheimer Disease; age from 18 Years

Sample size41

InterventionBrain CareNotes App

ComparatorAttention Control App — Active Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Enrollment41

Planned enrollment60

Follow-up durationSix months

Primary outcome measure 1App Usability at Six Months

Primary outcome measure 2App Acceptability at Six Months

Clinical bottom line

Caveats

Results not yet posted in registry; no efficacy or burden reduction data reported
Enrollment shortfall (41 of 60 planned); pilot feasibility design
Primary outcomes are usability and acceptability, not clinical or caregiver burden reduction
No demographic, baseline characteristics, or adverse event data reported in registry record

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Randomized controlled trial with active comparator; feasibility pilot phase.

Directness

moderate

Targets rural dementia caregivers; outcomes are usability and acceptability, not clinical burden reduction.

Consistency

insufficient

Registry record contains no results; consistency cannot be assessed.

Risk of bias

insufficient

Registry record does not report blinding, allocation concealment, or attrition data.

Sample adequacy

limited

Enrolled 41 of planned 60 participants; pilot feasibility design, not powered for efficacy.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT07054385). This is a study registration, not published results. Lead sponsor: Richard Holden. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 41 participants (ACTUAL). Conditions: Caregiver Burden, Alzheimer Disease. Interventions: BEHAVIORAL: Brain CareNotes; BEHAVIORAL: Dementia Guide Expert. Primary outcome measures: App Usability , Six Months; App Acceptability , Six Months. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Alzheimer DiseaseNCT07054385Caregiver BurdenRichard HoldenDementia Guide ExpertBrain CareNotes