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

NCT07054385 | Recruiting

• 1 other identifier: 27397
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden; Alzheimer Disease

Keywords

Alzheimer disease and related dementias; Caregiver; Caregiver Burden; Behavioral and psychological symptoms of dementia; Rural

Outcome Measures

Primary Outcomes (2)

• App Usability

  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.

  Six Months

• App Acceptability

  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.

  Six Months

Secondary Outcomes (2)

• Patient BPSD

  Six Months

• Caregiver Burden

  Six Months

Other Outcomes (6)

• Caregiver Depressive Symptoms

  Six Months

• Patient Acute Care Utilization

  Six Months

• Caregiver Acute Care Utilization

  Six Months

Study Arms (2)

Brain CareNotes App

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 App

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 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

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

• Richard Holden: lead

Study Sites (1)

Indiana University Bloomington

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

• Jordan R Hill, PhD

  Indiana University, Bloomington

  PRINCIPAL INVESTIGATOR

• Richard J Holden, PhD

  Indiana University, Bloomington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan R Hill, PhD

CONTACT

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

Richard J Holden, PhD

CONTACT

(317) 278-5323; rjholden@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The participant, primary investigator and outcome assessor will be masked to the app assignment (Brain CareNotes vs Attention Control App). The participant will be aware of the treatment received but is masked to whether the app they are assigned is the intervention versus control.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 8, 2025
• Study Start: July 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: November 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)