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

I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Hispanic Caregivers and Patients

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer Disease; Caregiver Burden
• Intervention / Treatment: Behavioral: Dementia Guide Expert; Behavioral: Brain CareNotes

Detailed Description

This study is a hybrid efficacy-effectiveness RCT to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes. Over 10 months, the trial will enroll 40 Hispanic caregivers. Participants will be randomized to use the Brain CareNotes app or an attention control education-only app (Dementia Guide Expert) for 12 months.

The primary objective is to test the the usability and acceptability, as well as needs met and unmet by Brain CareNotes among Hispanic caregivers of persons with dementia. Barriers in access and acceptance of dementia care resources have been previously identified including gaps in understanding of beliefs or practices between patients and local health systems, low health literacy, language barriers, and other cultural factors. These barriers may affect usability and acceptance of interventions. Therefore, it is hypothesized that average scores on the Simplified Systems Usability Scale will be less than 70 and low acceptance rates will be reported by more than 70% of the Hispanic co-hort. These measures will be administered at 3, 6 and 12 months.

The secondary objective is to examine the needs of Hispanic caregivers that are met and unmet by the Brain CareNotes intervention. Information on how unique culturally influenced needs were met or not met by Brain CareNotes will be collected and suggestions for changes to the intervention app will be identified. This aim will be addressed qualitatively by providing semi-structured interviews guided by the PROGRESS-PLUS framework to the Hispanic participants who received the Brain CareNotes intervention (n=20) about their experience with the intervention and suggestions for changes. The PROGRESS-PLUS framework addresses cultural and socio-economic factors that should be considered when creating behavioral interventions that are culturally compatible. It is expected that responses to interviews will identify themes consistent with a lack of cultural compatibility to factors identified by the PROGRESS-PLUS framework.

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Bloomington, Indiana, United States, 47405
      • Indiana University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Caregiver Inclusion Criteria:

• 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

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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: 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.
Active Comparator: Attention Control App; 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; 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."

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative Interview	Participants in the intervention group will complete semi-structured interviews guided by the PROGRESS-PLUS framework. The purpose of these interviews will be to determine their needs that were met or not met by the study intervention.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
App Use	Usage logs of app use over time.	12 months
Caregiver Self-efficacy	Caregiver perceived self-efficacy as measured using the Revised Scale for Caregiving Self-Efficacy. It consists of 3 sections each with five items. Participants rank self-efficacy on a scale of 0-100 for each item, with a higher score representing greater confidence. Thus, a high total score represents greater self-efficacy.	12 months
Caregiver Social Support	Caregiver perceived social support measured using the Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS is a 12-item questionnaire using a 7-point Likert scale where 1=very strongly disagree and 7=very strongly agree. Scores range from 12-84. A low score represents minimal social support while a high score represents a great level of perceived social support.	12 months
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.	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.	12 months

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: National Institute on Aging (NIA)
• Investigators: Principal Investigator: Richard J Holden, PhD, Indiana University; Principal Investigator: Malaz Boustani, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): September 26, 2023
• Primary Completion (Actual): October 20, 2025
• Study Completion (Actual): October 20, 2025

Study Registration Dates

• First Submitted: October 19, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 25, 2023

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Caregiver Burden; Behavioral and psychological symptoms of dementia; Alzheimer's disease and related dementias; Hispanic caregivers
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Stress, Psychological; Caregiver Burden; Alzheimer Disease; Behavior
• Other Study ID Numbers: 20311 (City of Hope Comprehensive Cancer Center); R01AG078234 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No