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

I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals

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 registry record for an active, ongoing randomized controlled trial testing a mobile app intervention (Brain CareNotes) for Hispanic caregivers of patients with Alzheimer's disease or related dementia. The trial measures usability and acceptability through validated questionnaires over 12 months. No outcome data are available in this registry record.

What was studied

Interventional, Randomized, Parallel, Double masking, Supportive Care purpose. Caregiver Burden, Alzheimer Disease; age from 18 Years. Intervention: Brain CareNotes. Compared with: Attention Control App — Active Comparator. n = 16. 1 site: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

Once results are reported, this trial will inform whether a mobile app intervention (Brain CareNotes) improves usability, acceptability, and perceived utility for Hispanic caregivers managing behavioral and psychological symptoms of dementia. The focus on a specific ethnic group and caregiver-centered outcomes addresses a gap in dementia care interventions.

Plain-language summary

This is an active, ongoing randomized controlled trial with planned enrollment of 40 participants evaluating usability and acceptability of a mobile app intervention in Hispanic caregivers; no results are reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measures: System Usability Scale (assessed at 3 months, 6 months,12 months); Behavioral Intention Questionnaire (assessed at 3 months, 6 months, 12 months)

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

PopulationCaregiver Burden, Alzheimer Disease; age from 18 Years

Sample size16

InterventionBrain CareNotes

ComparatorAttention Control App — Active Comparator

Setting1 site: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment40

Actual enrollment (at record date)16

Primary outcome measure 1System Usability Scale at 3, 6, and 12 months

Primary outcome measure 2Behavioral Intention Questionnaire at 3, 6, and 12 months

Study duration12 months

Clinical bottom line

Caveats

No outcome data are reported in this registry record; results are not yet available.
Actual enrollment (16 participants) is substantially below the planned target (40), limiting statistical power for the intended analysis.
Registry record does not specify allocation concealment, blinding procedures, or statistical analysis plan.
Surrogate endpoints (usability, acceptability) do not directly measure clinical outcomes such as reduction in caregiver burden or behavioral symptoms of dementia.

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

strong

Randomized controlled trial with active recruitment and planned 12-month follow-up.

Directness

moderate

Evaluates usability and acceptability via System Usability Scale and Behavioral Intention Questionnaire, not clinical outcomes.

Consistency

insufficient

No results reported; consistency cannot be assessed from registry record alone.

Risk of bias

insufficient

Randomized design reduces selection bias, but registry record provides no details on blinding, allocation concealment, or analysis plan.

Sample adequacy

limited

Planned enrollment 40 participants; actual enrollment reported as 16, suggesting small and possibly underpowered sample.

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 (NCT06099197). This is a study registration, not published results. Lead sponsor: Indiana University. Recruitment status: ACTIVE_NOT_RECRUITING. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 16 participants (ACTUAL). Conditions: Caregiver Burden, Alzheimer Disease. Interventions: BEHAVIORAL: Brain CareNotes; BEHAVIORAL: Dementia Guide Expert. Primary outcome measures: System Usability Scale , 3 months, 6 months,12 months; Behavioral Intention Questionnaire , 3 months, 6 months, 12 months. Brief summary: This study is a randomized, controlled trial (RCT) to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes, among unpaid Hispanic caregivers of patients with dementia. Brain CareNotes provides support for management of the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 10 months, the trial will enroll 40 Hispanic caregivers of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD). Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 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 DiseaseCaregiver BurdenIndiana UniversityDementia Guide ExpertNCT06099197Brain CareNotes