I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer's-related Symptoms for Caregivers and Patients
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PROJECT SUMMARY/ABSTRACT Among patients with Alzheimer’s disease and related dementias (ADRD) and their informal caregivers, behavioral and psychological symptoms of dementia (BPSD) are a critical need requiring scalable, evidence- based intervention. As many as 97% of patients with ADRD will ultimately experience BPSD, yet they are poorly managed and remain the top source of caregiver burden. Technology may be a solution; indeed, the National Institute on Aging and others demand mobile technology-based behavioral interventions to support informal caregivers of patients with ADRD. Systematic reviews and market analyses of existing mobile technologies or “apps” demonstrate promise but critical limitations: lack of scientific foundation and evidence of efficacy; missing features and functions; and low to moderate quality. Our interdisciplinary team followed the NIH Stage Model for Behavioral Intervention Development to: 1) establish an evidence-based intervention model for BPSD management (NIH Model Stage 0); 2) apply user- centered design to embed this evidence-based model into Brain CareNotes, a mobile telehealth app (NIH Model Stage IA); and 3) conduct I-CARE, a set-up pilot study that established the feasibility and potential efficacy of Brain CareNotes (NIH Model Stage IB-II). The pilot study demonstrated that at the 6-month endpoint, Brain CareNotes reduced informal caregiver burden and reduced BPSD. Here we propose I-CARE 2, a Stage III randomized clinical trial (RCT), as the next step in the NIH Stage Model. I-CARE 2 will evaluate the real-world efficacy of Brain CareNotes on the primary outcomes of informal caregiver burden and BPSD at 12 months. We plan to enroll N=160 community-dwelling, English-speaking informal caregivers of patients with ADRD, across the state of Indiana. Informal caregivers will be randomized (stratified by sex and race) to 12 months of Brain CareNotes (n=80) or Attention Control education-only app (Dementia Guide Expert) (n=80). Follow-up will occur at 12 months, with additional assessments at 6 months to test for early effects. We will test primary hypotheses that, relative to Attention Control, informal caregivers randomized to Brain CareNotes will have: (H1) lower caregiver burden as measured by the Caregiver Distress sub-score on the Neuropsychiatric Inventory (NPI); and (H2) lower BPSD as measured by the NPI Total Score. Secondary hypotheses will be tested comparing groups on (H3) depressive symptoms as measured by the Patient Health Questionnaire (PHQ)-9 and (H4) acute care utilization as determined by the number of hospital and emergency room visits captured in the statewide regional health information exchange. If successful, this NIH Stage III RCT study will yield evidence of the efficacy of a highly scalable non- pharmacological intervention for BPSD, one of the most burdensome aspects of ADRD care. If our caregiver- facing mobile telehealth app is efficacious in real-world settings, subsequent Stage IV-V effectiveness and implementation research efforts can help relieve the critical public health burden of ADRD.
