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NCT Number: NCT07792889

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

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.

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Key information

Conditions

Caregiver Burden of People With Dementia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Caregivers of individuals with non-dementia related disease.

Treatment and study plan

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.

Dementia Care app

Other

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

Primary outcomes

  1. Feasibility of the intervention will be measured by recruitment rate

    Time frame: After 6 months participation completed.

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

  2. Data completion

    Time frame: After 6 month participation.

    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.

  3. System Usability Scale (SUS)

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

    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

  4. Accessibility of Intervention Measure (AIM)

    Time frame: Baseline, 3 and 6 month follow up appointment.

    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.

Secondary outcomes

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

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

    The Neuropsychiatric Inventory Questionnaire (NPI-Q) is a brief clinical measurement filled out by a caregiver to assess behavioral and psychological symptoms in dementia across 12 domains (e.g., agitation, depression, anxiety, apathy, delusions, hallucinations). It takes about 5-10 minutes to complete. Symptom severity score ranges from 0-36 and the caregiver distress score ranges for 0-60. Higher scores indicate greater behavioral severity and heavier caregiver burden.

Study contacts

Contact information is provided by the study sponsor or research team.

Miriam Rodriguez, PhD

CONTACT

[email protected]

812-856-1661

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

FAMILIA: Focused Adaptation of a Mobile Intervention for Dementia Caregivers

Acronym: FAMILIA

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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