Clinical trial NCT06099197: I-CARE 2: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms in Hispanic Individuals
Official title: I-CARE 2 RCT: Mobile Telehealth to Reduce Alzheimer'S-related Symptoms for Hispanic Caregivers and Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Burden
Alzheimer Disease
Keywords: Alzheimer's disease and related dementias
Hispanic caregivers
Caregiver Burden
Behavioral and psychological symptoms of dementia
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2023-10-25
Enrollment: 40
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 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.

Detailed 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.

Eligibility criteria: Caregiver Inclusion Criteria:

* Self-identified primary unpaid Hispanic caregiver of a person diagnosed with ADRD (at any stage) who are:
* Receiving primary care and
* Community-dwelling;
* English literate;
* Age ≥ 18 years

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: System Usability Scale
timeFrame: 3 months, 6 months,12 months
measure: Behavioral Intention Questionnaire
timeFrame: 3 months, 6 months, 12 months
Secondary outcomes:
measure: Qualitative Interview
timeFrame: 12 months
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Indiana University
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: