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

Sponsor

Indiana University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05733520

Collaborator

National Institute on Aging (NIA) (NIH), Regenstrief Institute, Inc. (Other)

160

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This study is an RCT to evaluate the effect of Brain CareNotes on the burden experienced by informal 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 160 caregiver-patient dyads consisting of community-dwelling patients diagnosed with Alzheimer's disease or a related dementia (ADRD) and their informal caregiver. Caregivers will be randomized to use the Brain CareNotes app or an attention control education-only app for 12 months, with usage reminders.

Condition or Disease	Intervention/Treatment	Phase
Caregiver Burden Alzheimer Disease	Behavioral: Brain CareNotes Behavioral: Dementia Guide Expert	N/A

Detailed Description

This study is a hybrid efficacy-effectiveness RCT to evaluate the effect of Brain CareNotes on informal caregiver burden and patient BPSD. Over 39 months, the trial will enroll 160 dyads (consisting of one adult informal caregiver and one patient living with ADRD for whom the caregiver provides care). 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. We hypothesize that caregiver burden and patient BPSD will be lower among those dyads randomized to the Brain CareNotes intervention compared to those randomized to the education-only attention control app at 12 months. Our 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. We 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. We hypothesize that dyads 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, we 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

160 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The primary investigator and outcome assessor will be masked to the App assignment (Brain CareNotes vs Attention Control App)

Primary Purpose:

Supportive Care

Official Title:

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

Anticipated Study Start Date :

Mar 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2027

Anticipated Study Completion Date :

Feb 29, 2028

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Brain CareNotes App	Behavioral: Brain CareNotes The Brain CareNotes mobile telehealth app is used by informal 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.
Active Comparator: Attention Control App	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."

Arm

Intervention/Treatment

Experimental: Brain CareNotes App

Behavioral: Brain CareNotes

The Brain CareNotes mobile telehealth app is used by informal 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.

Active Comparator: Attention Control App

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."

Outcome Measures

Primary Outcome Measures

Caregiver Burden [12 months]
The burden experienced by caregivers caused by their caregiving responsibilities measured by the Neuropsychiatric Inventory (NPI) caregiver distress sub-score.
Patient BPSD [12 months]
Behavioral (e.g. agitation, aggression, wandering) and psychological (e.g. delusions, hallucinations) symptoms of dementia as measured by the Neuropsychiatric Inventory (NPI).

Secondary Outcome Measures

Caregiver Depressive Symptoms [12 months]
Caregiver depression as measured by the Patient Health Questionnaire (PHQ)-9
Caregiver Acute Care Utilization [12 months]
Caregiver visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.
Patient Acute Care Utilization [12 months]
Patient visits to emergency rooms, hospitals, or inpatient diagnoses. Obtained from caregiver self-reports or medical records.

Other Outcome Measures

Caregiver Self-efficacy [12 months]
Caregiver perceived self-efficacy as measured using the Revised Scale for Caregiving Self-Efficacy
Caregiver Social Support [12 months]
Caregiver perceived social support measured using the Multidimensional Scale of Perceived Social Support (MSPSS)
System Usability Scale [12 months]
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
Behavioral Intention Questionnaire [12 months]
4-item questionnaire assessing a user's intention to use a technology in the near future.
App Use [12 months]
Usage logs of app use over time.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Caregiver Inclusion Criteria:

Self-identified primary informal 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)