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

Alzheimer Disease Clinical Trial

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

Status Recruiting

Clinical Trial Summary

This study is a randomized, controlled trial (RCT) to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes, among unpaid Hispanic caregivers of patients with dementia. Brain CareNotes provides support for management of 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.

Clinical Trial Description

This study is a hybrid efficacy-effectiveness RCT to evaluate usability and acceptability, and met and unmet needs from a caregiver intervention app, Brain CareNotes. 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 the usability and acceptability, as well as needs met and unmet by Brain CareNotes among Hispanic caregivers of persons with dementia. Barriers in access and acceptance of dementia care resources have been previously identified including gaps in understanding of beliefs or practices between patients and local health systems, low health literacy, language barriers, and other cultural factors. These barriers may affect usability and acceptance of interventions. Therefore, it is hypothesized that average scores on the Simplified Systems Usability Scale will be less than 70 and low acceptance rates will be reported by more than 70% of the Hispanic co-hort. These measures will be administered at 3, 6 and 12 months.

The secondary objective is to examine the needs of Hispanic caregivers that are met and unmet by the Brain CareNotes intervention. Information on how unique culturally influenced needs were met or not met by Brain CareNotes will be collected and suggestions for changes to the intervention app will be identified. This aim will be addressed qualitatively by providing semi-structured interviews guided by the PROGRESS-PLUS framework to the Hispanic participants who received the Brain CareNotes intervention (n=20) about their experience with the intervention and suggestions for changes. The PROGRESS-PLUS framework addresses cultural and socio-economic factors that should be considered when creating behavioral interventions that are culturally compatible. It is expected that responses to interviews will identify themes consistent with a lack of cultural compatibility to factors identified by the PROGRESS-PLUS framework. ;

Related Conditions & MeSH terms

• Alzheimer Disease
• Caregiver Burden

• NCT number: NCT06099197
• Study type: Interventional
• Source: Indiana University
• Contact: Miriam J Rodriguez, PhD
• Phone: (812) 856-1661
• Email: mijrodri@iu.edu
• Status: Recruiting
• Phase: N/A
• Start date: September 26, 2023
• Completion date: July 2025