I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Brain CareNotes, Dementia Guide Expert.
- Who it may be relevant to
- Registry conditions: Caregiver Burden, Alzheimer Disease. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Caregivers and Patients
Overview
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.
Detailed description
This study is a hybrid efficacy-effectiveness RCT to evaluate the effect of Brain CareNotes on unpaid caregiver burden and patient BPSD. Over 39 months, the trial will enroll 184 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, 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, 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.
Interventions
- 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. - 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."
Primary outcome measures
- Caregiver Burden [Time frame: 12 months]
- Patient BPSD [Time frame: 12 months]
Secondary outcome measures (3)
- Caregiver Depressive Symptoms [Time frame: 12 months]
- Caregiver Acute Care Utilization [Time frame: 12 months]
- Patient Acute Care Utilization [Time frame: 12 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- IU Health — Indianapolis
- Community Health Network — Indianapolis
Identifiers
NCT: NCT05733520 · 15749 · R01AG078234