Recruiting

Mobile Telehealth

Sponsor:

Indiana University

Code:

NCT05733520

Conditions

Caregiver Burden

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Brain CareNotes

Dementia Guide Expert

Study Details

Brief summary:

This study is a randomized, controlled trial (RCT) to evaluate the effect of Brain CareNotes (a mobile health application) on the burden experienced by unpaid caregivers of patients with dementia and on the behavioral and psychological symptoms of dementia (BPSD) displayed by care recipients. Over 39 months, the trial will enroll 184 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

Study ID

NCT05733520

Start date

May 30, 2023

Status verified date

Nov, 2025

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Caregiver Inclusion Criteria:

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

Caregiver 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 Design

Enrollment

184 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Brain CareNotes App

active comparator: Attention Control App

Interventions

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.

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."

Primary outcome measure

  • Caregiver Burden [ Time Frame: 12 months ]
  • Patient BPSD [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Miriam J Rodriguez, PhD

(812) 856-1661mijrodri@iu.edu

Jordan R Hill, PhD

812-856-5032jrh6@iu.edu

Locations

IU Health

Recruiting

Indianapolis, Indiana, United States, 46202

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46203

More Information

Sponsor

Indiana University

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Keywords

  • Alzheimer's disease and related dementias
  • Caregiver
  • Caregiver Burden
  • Behavioral and psychological symptoms of dementia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2025-11-24.