I-CARE 2: mobile Telehealth to Reduce Alzheimer'S-related Symptoms

Authors
Category Primary study
Registry of TrialsClinicalTrials.gov
Year 2023
This study is a hybrid efficacy‐effectiveness RCT to evaluate the effect of BrainCareNotes on unpaid caregiver burden and patient BPSD. Over 39 months, the trial willenroll 200 caregivers. Participants will be randomized to use the Brain CareNotes app oran 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 andb) patient BPSD at 12 months. The investigators hypothesize that caregiver burden andpatient BPSD will be lower among those participants randomized to the Brain CareNotesintervention compared to those randomized to the education‐only attention control app at12 months. The primary, powered outcomes are calculated using the caregiver‐reportedNeuropsychiatric Inventory (NPI); the total NPI score measures patient BSPD and thecaregiver distress sub‐score measures caregiver burden. The investigators will obtain NPIresponses from caregivers at baseline, six, and 12 months.The secondary objective is to test the effect of Brain CareNotes on a) caregiverdepressive symptoms and b) patient and caregiver acute care utilization at 12 months. Theinvestigators hypothesize that participants randomized to the Brain CareNotesintervention will have lower caregiver depressive symptoms and decreased acute careutilization compared to those randomized to the control app. For caregiver depressivesymptoms, investigators will use the researcher‐administered Patient HealthQuestionnaire‐9 (PHQ‐9) at baseline, six, and 12 months. Acute care utilization data willbe 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' andpatients' hospital and ER visits that occurred within 12 months of enrollment.
Epistemonikos ID: e27871ba27de9c68c7bfe8e31655940e508f129a
First added on: Feb 19, 2024