AIM 3 Focused Adaptation of a Mobile Caregiver Intervention for Dementia Caregivers

NCT07792889 | Not Yet Recruiting

• 2 other identifiers: 32712K23AG084856
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to evaluate usability, feasibility and preliminary efficacy of a mobile telehealth supported behavioral intervention for caregivers of persons with dementia who identify as Hispanic. The main question it aims to answer is: "is a mobile telehealth supported behavioral intervention aimed at supporting caregivers in managing behavioral and psychological symptoms of dementia (BPSD) usable and acceptable and can it preliminarily reduce depressive symptoms and caregiver burden after 6 months of exposure? Hypothesis: The mobile/telehealth supported intervention will be feasible, as indicated by recruitment and retention rates, data completion, and usability and acceptance measures. Exploratory Hypothesis: The mobile/telehealth supported intervention will improve caregiver burden and reduce BPSD as measured by the Neuropsychiatric Inventory (NPI-Q). Researchers will compare an intervention group to a control group to see if there are differences in preliminary outcomes. Participants will communicate with care coaches through the app and through individualized remotely delivered sessions. The app generates advice cards to develop a care plan that addresses behavioral and psychological symptoms of dementia (BPSD), and tracks cognitive, functional, behavioral and psychological symptoms of the patient and informal caregiver participant's health and quality of life. Individual care coach sessions will focus on management of BPSD and caregiver burden.

Conditions

Caregiver Burden of People With Dementia

Outcome Measures

Primary Outcomes (4)

• Feasibility of the intervention will be measured by recruitment rate

  recruitment rate will be calculated by calculating No. approached, No. agreeing, No. consenting, and No. consenting/No. approached.

  After 6 months participation completed.

• Data completion

  Data completion will be collected continually and computed after the final assessment by calculating No. of complete caregiver burden and BPSD assessments per consenting participant/total No. of possible assessments. We will separately compute missing data and attrition for all causes vs. death in the intervention vs. control groups. An enrollment and completion rate of 80% will be considered evidence for successful feasibility.

  After 6 month participation.

• System Usability Scale (SUS)

  The System Usability Scale (SUS) is a 10-item questionnaire scored on a 5-point Likert scale (1 = "Strongly Disagree" to 5 = "Strongly Agree"). Total administration time is 1-2 minutes. The total score range is 0 to 100 ( calculated using a specific scoring formula, not a simple percentage). Identified benchmarks will include mean SUS scores of 68 and above. English and Spanish versions of the SUS will be administered to measure usability

  The SUS will be administered at baseline, 3 and 6 month follow up appointment.

• Accessibility of Intervention Measure (AIM)

  The Acceptability of Intervention Measure (AIM) (developed by Weiner et al., 2017) consists of 4 items rated on a 5-point Likert scale (1 = "Completely Disagree" to 5 = "Completely Agree"). Total administration time is 1-2 minutes. Average score of1 to 5 is calculated by averaging all 4 items. Summed total score range is 4 to 20 (calculated by adding all 4 items together). Higher scores indicate greater intervention acceptability. English and Spanish versions of the AIM will be administered.

  Baseline, 3 and 6 month follow up appointment.

Secondary Outcomes (1)

• Caregiver burden and patient BPSD severity will be measured by the Neuropsychiatric Inventory Questionnaire (NPI-Q)

  To be collected at baseline, 3 and 6 month follow up.

Study Arms (2)

Mobile/telehealth supported behavioral intervention

EXPERIMENTAL

This arm will include participants receiving the intervention

Behavioral: Brain CareNotes Latino

Control group

PLACEBO COMPARATOR

Control groups will receive an information only app

Other: Dementia Care app

Interventions

Brain CareNotes Latino BEHAVIORAL

This is a mobile app supported behavioral intervention. Caregivers/ participants will communicate with care coaches through the app and through individualized remotely delivered sessions. The app generates advice cards to develop a care plan that addresses behavioral and psychological symptoms of dementia (BPSD), and tracks cognitive, functional, behavioral and psychological symptoms of the patient and informal caregiver participant's health and quality of life. Individual care coach sessions will focus on management of BPSD and caregiver burden.

Mobile/telehealth supported behavioral intervention

Dementia Care app OTHER

Information only app that is freely available in the app store and provides information on dementia care.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Self-identify as Hispanic/Latino and are informal caregivers of a person with dementia.
• Able to speak or read English or Spanish
• Able to use technology as measured by a technology screening measure.
• Age 18 and older

You may not qualify if:

• \- Caregivers of individuals with non-dementia related disease.

Sponsors & Collaborators

• Indiana University: lead
• National Institute on Aging (NIA): collaborator

Central Study Contacts

Miriam Rodriguez, PhD

CONTACT

812-856-1661; mijrodri@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 19, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): March 1, 2027
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share