Testing & Refinement of CarePair: An Assessment and Referral Platform to Support Family Caregivers of Alzheimer's Disease and Related Dementias.

NCT ID: NCT06418971

Last Updated: 2025-11-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2026-05-31

Brief Summary

The purpose of this study is to develop and test CarePair, a mobile application-based needs assessment and service referral platform for family caregivers of persons with dementia designed to alleviate stress and promote psychosocial well being.

The main aims of this study are:

• To evaluate the feasibility and acceptability of the CarePair mobile application.
• To explore the potential for CarePair to reduce feelings of depression and burden, and improve caregivers' feelings of self-efficacy.

Caregiver participants will be asked to log in and use the CarePair application and complete study activities for a six-week duration. Researchers will compare the intervention group to an attention control comparator to see if application use is associated with improved psychosocial outcomes at follow-up.

Detailed Description

In 2024, approximately 6.9 million diagnosed cases of Alzheimer's disease and related dementias (ADRD) were reported in the United States, with 83% of the caregiving burden shouldered by unpaid family members or friends. The duration of ADRD varies between 4-20 years, during which individuals often transition into a state of complete dependency. Without family caregivers, the long-term services and support system would be unsustainable. The dearth of accessible support for ADRD caregivers constitutes a significant public health emergency. Caregivers are frequently uncertain of which services are needed, available, and how to gain access - often leaving those most vulnerable without essential support. When queried about service underuse, study respondents who participated in the K99 phase of this project highlighted an information deficit tailored to specific cultures, demographics, and dementia types. They described the excess of online information as overwhelming, often irrelevant, impractical, or unaffordable. Existing technology-based solutions targeted toward enhancing personalized caregiver support are limited. Leveraging continued innovations in technology to inform the training and testing of machine learning algorithms, which can match and update resources while accounting for individual needs, preferences (in-person, virtual), and barriers (e.g., employment, lack of respite care), holds great potential to enhance the precision of service linkage for ADRD caregivers. This R00 project aims to develop, refine, and pilot test CarePair (formerly the Caregiver Resource Room), a mobile application assessment and service referral platform for dementia caregivers. CarePair will leverage innovative machine learning algorithms to holistically evaluate caregivers' evolving needs, their barriers, and preferences to generate personalized service referrals relevant to their areas of identified need. Thus, the specific aims of the R00 are to 1) Use mixed-method and focus group data from the K99 phase to inform the iterative development of the CarePair, which includes a digital self-assessment tool employing machine learning to identify needs, categorize them, and generate targeted service recommendations; 2) Evaluate front- and back-end usability (e.g., via task analysis, heuristic evaluation) of the tool's content, design, features, functionality, and accuracy of service output. Feedback will inform modifications and iterative refinement of the CarePair Version 2.0; 3) Conduct a pilot randomized controlled trial to assess the feasibility, acceptability, and preliminary efficacy of CarePair in enhancing service awareness, addressing unmet needs, and improving mental health. The proposed research aligns with the NIA's strategic initiative to foster research scientists in aging and to develop promising interventions to better engage and support the well-being of ADRD family caregivers.

Conditions

Caregiver Burden; Caregiver Burnout; Dementia

Keywords

Dementia family caregivers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Control Arm

Participants randomized to the control arm will receive access to an attention-matched comparator: a digital folder containing the same caregiving articles available in the CarePair app. However, the materials will not be personalized or organized. Participants will be asked to log into the digital folder twice per week and read one article at each login, for a total of 12 logins and articles over the 6-week study period, mirroring the engagement frequency of the intervention group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

CarePair Intervention Arm

Participants randomized to the intervention arm will receive access to the CarePair app, a needs-based digital platform that delivers tailored recommendations for Alzheimer's disease and related dementias (ADRD) resources designed for family caregivers. These include services and educational articles personalized based on the caregiver's self-reported needs and preferences, with content organized by relevance to each user. Participants will be asked to log into the CarePair app twice per week and engage with one article per login, for a total of 12 logins and articles over the 6-week study period.

Group Type: EXPERIMENTAL

CarePair

Intervention Type: BEHAVIORAL

This study will pilot test the feasibility and acceptability of a digital self-assessment and referral tool using machine learning models to enhance service use and address unmet needs in ADRD caregivers.

Interventions

CarePair

This study will pilot test the feasibility and acceptability of a digital self-assessment and referral tool using machine learning models to enhance service use and address unmet needs in ADRD caregivers.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Currently a primary caregiver of a community-dwelling PwD
• Provides at least 10 hours of care per week
• ≥18 years of age
• Fluent in English
• Both the caregiver and care-recipient reside in and/or can easily access one of the following cities/areas: New York City, New York (NY); Long Island, NY; Westchester County, NY; Seattle, Washington (WA); Los Angeles, California (CA)
• Provides at least 10 hours of care per week
• Has provided care for at least 6 months
• Able to use the internet and has internet access
• Owns and can operate a smartphone
• Able and willing to provide their informed consent to participate for the six-week study duration
• Does not self-report any cognitive impairments

Exclusion:

• Not currently the primary caregiver of a community-dwelling person with dementia
• Care-recipient lives in residential care (e.g., assisted living, skilled nursing facility)
• ≤18 years of age
• Not fluent in English
• The caregiver and/or care-recipient resides outside of and/or cannot easily access any of the following cities: New York City (NY); Long Island (NY); Westchester County (NY); Seattle (WA); Los Angeles (CA)
• Provides less than 10 hours of care per week
• Has provided care for less than 6 months
• Unable to use the internet or does not have internet access
• Does not own and/or cannot operate a smartphone
• Unable or unwilling to provide informed consent to participate for the six-week study duration
• Self-reports having a cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

Francesca B Falzarano

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Francesca Falzarano, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

University of Southern California

Los Angeles, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Francesca B Falzarano, PhD

Role: CONTACT

Phone: 6464812858

Email: falzaran@usc.edu

Annabelle V Greenfield, BS

Role: CONTACT

Phone: 6467809506

Email: ag69282@usc.edu

Facility Contacts

Annabelle Greenfield, B.S.

Role: primary

Other Identifiers

R00AG073509

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UP-25-00690

Identifier Type: -

Identifier Source: org_study_id