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

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Indiana University

Status

Enrolling

Conditions

Alzheimer Disease
Caregiver Burden

Treatments

Behavioral: Brain CareNotes
Behavioral: Dementia Guide Expert

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT06099197
R01AG078234 (U.S. NIH Grant/Contract)
20311 (Other Identifier)

Details and patient eligibility

About

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 Hispanic caregivers of patients with dementia and on 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.

Full description

This study is a hybrid efficacy-effectiveness RCT to evaluate the effect of Brain CareNotes on unpaid caregiver burden and patient BPSD. 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 effect of Brain CareNotes on a) caregiver burden and b) patient BPSD at 12 months. The investigators hypothesize that caregiver burden and patient BPSD will be lower among those participants randomized to the Brain CareNotes intervention compared to those randomized to the education-only attention control app at 12 months. The primary, powered outcomes are calculated using the caregiver-reported Neuropsychiatric Inventory (NPI); the total NPI score measures patient BSPD and the caregiver distress sub-score measures caregiver burden. The investigators will obtain NPI responses from caregivers at baseline, three, six, and 12 months. The secondary objective is to test the effect of Brain CareNotes on a) caregiver depressive symptoms and b) patient and caregiver acute care utilization at 12 months. The investigators hypothesize that participants randomized to the Brain CareNotes intervention will have lower caregiver depressive symptoms and decreased acute care utilization compared to those randomized to the control app. For caregiver depressive symptoms, investigators will use the researcher-administered Patient Health Questionnaire-9 (PHQ-9) at baseline, three, six, and 12 months. Acute care utilization data will be obtained from self-reports or Indiana's statewide Health Information Exchange (HIE), known as the Indiana Network for Patient Care (INPC), to identify both caregivers' and patients' hospital and ER visits that occurred within 12 months of enrollment. The final objective is to determine the shortcomings of Brain CareNotes in supporting the specific needs of Hispanic caregivers. Upon their completion of the study, participants in the intervention arm will complete semi-structured qualitative interviews.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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)

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

40 participants in 2 patient groups

Brain CareNotes
Experimental group
Description:
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.
Treatment:
Behavioral: Brain CareNotes
Attention Control App
Active Comparator group
Description:
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."
Treatment:
Behavioral: Dementia Guide Expert

Trial contacts and locations

0

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Central trial contact

Miriam J Rodriguez, PhD; Jordan R Hill, PhD

Data sourced from clinicaltrials.gov

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