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

NCT06099197 | Recruiting DMC

• 2 other identifiers: 20311R01AG078234
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden; Alzheimer Disease

Keywords

Alzheimer's disease and related dementias; Hispanic caregivers; Caregiver Burden; Behavioral and psychological symptoms of dementia

Outcome Measures

Primary Outcomes (2)

• System Usability Scale

  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.

  3 months, 6 months,12 months

• Behavioral Intention Questionnaire

  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.

  3 months, 6 months, 12 months

Secondary Outcomes (1)

• Qualitative Interview

  12 months

Study Arms (2)

Brain CareNotes

EXPERIMENTAL

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

Attention Control App

ACTIVE COMPARATOR

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

Interventions

Brain CareNotes BEHAVIORAL

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.

Brain CareNotes

Dementia Guide Expert BEHAVIORAL

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."

Attention Control App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Indiana University

Bloomington, Indiana, 47405, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden; Alzheimer Disease; Behavior

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Richard J Holden, PhD

  Indiana University

  PRINCIPAL INVESTIGATOR

• Malaz Boustani, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miriam J Rodriguez, PhD

CONTACT

(812) 856-1661; mijrodri@iu.edu

Jordan R Hill, PhD

CONTACT

(812) 856-5032; jrh6@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The primary investigator and outcome assessor will be masked to the app assignment (Brain CareNotes vs Attention Control App).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Participants will be randomized to receive the Brain CareNotes app or an attention control app.

Study Record Dates

• First Submitted: October 19, 2023
• First Posted: October 25, 2023
• Study Start: September 26, 2023
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)