Clinical trial NCT05733520: I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms
Official title: I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Caregivers and Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Alzheimer Disease
Keywords: Alzheimer's disease and related dementias
Caregiver
Caregiver Burden
Behavioral and psychological symptoms of dementia
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
name: Regenstrief Institute, Inc.
First posted: 2023-02-17
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to receive the Brain CareNotes app or an attention control app.
Primary purpose: SUPPORTIVE_CARE

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 160 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 160 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.

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)

Primary outcomes:
measure: Caregiver Burden
timeFrame: 12 months
measure: Patient BPSD
timeFrame: 12 months
Secondary outcomes:
measure: Caregiver Depressive Symptoms
timeFrame: 12 months
measure: Caregiver Acute Care Utilization
timeFrame: 12 months
measure: Patient Acute Care Utilization
timeFrame: 12 months
Other outcomes:
measure: Caregiver Self-efficacy
timeFrame: 12 months
measure: Caregiver Social Support
timeFrame: 12 months
measure: System Usability Scale
timeFrame: 12 months
measure: Behavioral Intention Questionnaire
timeFrame: 12 months
measure: App Use
timeFrame: 12 months
Locations:
city: Indianapolis
country: United States
facility: IU Health
state: Indiana
city: Indianapolis
country: United States
facility: Community Health Network
state: Indiana
Study officials:
affiliation: Indiana University
name: Richard J Holden, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Indiana University
name: Malaz Boustani, MD
role: PRINCIPAL_INVESTIGATOR
References: