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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Caregiver Burden, Alzheimer Disease

Intervention / Treatment
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* Behavioral: Brain CareNotes
* Behavioral: Dementia Guide Expert


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Participants will be randomized to receive the Brain CareNotes app or an attention control app.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brain CareNotes<br>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<br>* 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.<br>|
| Active Comparator: Attention Control App<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Burden | The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score. The distress score is calculated by adding the distress score for each of the 12 items of the NPI. A score of 0 would indicate that the BPSD cause no distress while a score of 60 would indicate that each symptom causes severe distress for the caregiver. | 12 months | 
| Patient BPSD | Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI). The NPI is a 12-item questionnaire. The total score is calculated by adding the product of the frequency and severity of those 12 items. A score of 0 would indicate that no symptoms are present while a score of 144 would indicate that all symptoms are present at the highest level of frequency and severity. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caregiver Depressive Symptoms | Caregiver depression as measured by the Patient Health Questionnaire (PHQ)-9. The PHQ-9 is a 9-item questionnaire using a 0-3 rating scale. Scores range from 0-27. A total score of 0 represents no depression, while score of 5, 10, 15, and 20 serve as cut points for mild, moderate, moderately severe, and severe depression, respectively. | 12 months | 
| Caregiver Acute Care Utilization | Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records. | 12 months | 
| Patient Acute Care Utilization | Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's disease and related dementias, Hispanic caregivers, Caregiver Burden, Behavioral and psychological symptoms of dementia