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

March 3, 2026 updated by: Francesca B Falzarano, University of Southern California

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Francesca B Falzarano, PhD
  • Phone Number: 6464812858
  • Email: falzaran@usc.edu

Study Contact Backup

  • Name: Annabelle V Greenfield, BS
  • Phone Number: 6467809506
  • Email: ag69282@usc.edu

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Recruiting
        • University of Southern California
        • Principal Investigator:
          • Francesca Falzarano, PhD
        • Contact:
          • Annabelle Greenfield, B.S.
          • Phone Number: 7603307425
          • Email: ag69282@usc.edu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: 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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The Feasibility of the CarePair study as measured by the proportion of family caregivers who complete the study screening survey.
Time Frame: Enrollment
The feasibility of the CarePair study will be measured by the proportion of family caregivers who complete the study screening survey among those who were directly invited to participate the study.
Enrollment
The Feasibility of the CarePair study as measured by the proportion of family caregivers who consent to participate and are enrolled.
Time Frame: Enrollment
The feasibility of the CarePair study will be measured by the proportion of family caregivers who consent to participate among those who were screened into the study. Participants who consent to participate are then immediately randomized to their assigned condition and thus enrolled.
Enrollment
The Feasibility of the CarePair study as measured by the proportion of are deemed eligible based on screening criteria.
Time Frame: Enrollment
The feasibility of the CarePair study will be measured by the proportion of family caregivers who are deemed eligible to participate based on screening criteria among those who completed the study's screening survey.
Enrollment
The Feasibility of the CarePair study as measured by recruitment rates and the proportion of family caregivers that decline participation.
Time Frame: Enrollment
The feasibility of the CarePair study will be measured by the proportion of eligible family caregivers who decline to participate among those who were screened into the study.
Enrollment
The Feasibility of the CarePair study as measured by participant retention, as indicated by the number of recorded dropouts.
Time Frame: Enrollment to 6-Week Follow-Up
Participant retention, as an indicator of feasibility, will be assessed by recording the number of participants who withdraw from the study after enrollment
Enrollment to 6-Week Follow-Up
The Feasibility of the CarePair application as measured by the number of app logins per participant out of total required (minimum= 12).
Time Frame: Baseline to 6-Week Follow-Up
The feasibility of the application will be measured by the number of times the participant logs in to the CarePair application. The minimum number of logins recommended to the participants is 12 (2x/week for 6 weeks).
Baseline to 6-Week Follow-Up
Application Usability, as measured using the validated System Usability Scale (SUS).
Time Frame: 6-Week Follow-Up
Usability and accessibility of the CarePair application design will be measured using the validated System Usability Scale (SUS). Total scores for the SUS range from 0-100, with higher scores indicative of greater usability. A threshold score of 68 is used to indicate adequate usability.
6-Week Follow-Up
Application usability, as measured using the validated User Version of the Mobile App Rating Scale (uMARS).
Time Frame: 6-Week Follow-Up
Usability of the CarePair application will be measured using the validated user version of the Mobile App Rating Scale (uMARS). The uMARS provides a multidimensional assessment of app quality, including engagement, functionality, aesthetics, and information. Scores range from 20 to 100, with higher scores indicating more favorable user evaluations of the app's usability and overall quality.
6-Week Follow-Up
The Feasibility of the CarePair study as measured by participant retention, as indicated by the number of participants lost to follow-up.
Time Frame: Enrollment to 6-Week Follow-Up
Participant retention, as an aspect of feasibility, will be measured by the recorded number of participants number lost to follow-up. A number of the enrolled participants who the study team contacted weekly for 4 weeks, but did not answer or continue participation, will be recorded.
Enrollment to 6-Week Follow-Up
The Acceptability of the CarePair application as measured by a survey that measures the participants satisfaction and acceptability of the application.
Time Frame: 6-Week Follow-Up

The acceptability of the CarePair application will be measured by the use of surveys assessing usability, engagement, acceptability, suggestions for improvement.

Participants will be asked to rate their agreement with statements including "I enjoyed my experience using the CarePair application". Response options are rated on a five-point scale from 1-Strongly Disagree to 5-Strongly Agree. Scores range from 9-45, with higher scores indicating greater satisfaction and acceptability.
6-Week Follow-Up
The Acceptability of the CarePair application as measured by a qualitative survey that measures the participants satisfaction and acceptability of the application.
Time Frame: 6-Week Follow-Up
The acceptability of the CarePair application will be measured by the use of open-ended items assessing usability, engagement, acceptability, suggestions for improvement. The intervention group participants will be administered five open-ended qualitative items asking for feedback on CarePair. Sample items include: "Would you continue using the CarePair application after this study? Why or why not?"
6-Week Follow-Up
The Feasibility of the CarePair application as measured by the number of app interactions per participant out of total required (minimum= 12).
Time Frame: Baseline to 6-Week Follow-Up
Feasibility of the application will be assessed based on the number of participant interactions with CarePair's features, such as reviewing, rating, taking notes on, or saving services or articles. Participants are asked to log in and engage with the app approximately twice per week over the six-week study period, for a recommended minimum of 12 total interactions.
Baseline to 6-Week Follow-Up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline Caregiving Self-Efficacy scores on the 15-item Revised Scale for Caregiving Self-Efficacy
Time Frame: Baseline; 6-Week Follow-Up
Caregiving Self-Efficacy will be measured using the Revised Scale for Caregiving Self-Efficacy. Total scores range from 0-100, with higher scores indicative of greater feelings of perceived self-efficacy.
Baseline; 6-Week Follow-Up
Change from Baseline Caregiver Depressive Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9).
Time Frame: Baseline; 6-Week Follow-Up
The PHQ-9 will be used to measure family caregiver depressive symptoms. Total scores range from 0-27, with higher scores indicative of greater caregiver depressive symptoms.
Baseline; 6-Week Follow-Up
Change from Baseline Anxiety scores on the Generalized Anxiety Disorder-7 (GAD-7)
Time Frame: Baseline; 6-Week Follow-Up
Change in caregivers' anxiety scores will be assessed using the GAD-7. Scores range from 0-21, with higher scores indicating a greater level of anxiety.
Baseline; 6-Week Follow-Up
Change from Baseline Caregiver Stress as measured by the Kingston Caregiver Stress Scale (KCSS)
Time Frame: Baseline; 6-Week Follow-Up
The KCSS will be used to measure family caregiver stress. Total scores range from 20-50, with higher scores indicative of greater caregiver stress.
Baseline; 6-Week Follow-Up
Change from Baseline Quality of Life scores on the 5-item Satisfaction with Life Scale (SWLS)
Time Frame: Baseline; 6-Week Follow-Up
The SWLS will be used to measure family caregiver quality of life. Total scores range from 5-35, with a score of 20 representing a neutral point on the scale. Higher scores indicate a greater level of satisfaction with life.
Baseline; 6-Week Follow-Up
Change from Baseline Caregiver Needs scores on a 12-item Needs Assessment
Time Frame: Baseline; 6-Week Follow-Up
A 12-item caregiver needs assessment will be used to measure family caregivers' care-related needs, such as legal guidance, social support, and education. Total scores range from 12-48, with higher scores representing greater caregiver needs.
Baseline; 6-Week Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Francesca Falzarano, PhD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 17, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UP-25-00690
  • R00AG073509 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data collected for the CarePair study will only be shared after the investigators have published the data addressing the study's specific aims. Intellectual property and data generated under this project will be administered in accordance with both University of Southern California (USC) and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance. After publication of the investigator's main findings, access to databases and associated software tools generated and the code to create these tools under the project will be available for educational, research and non-profit purposes.

IPD Sharing Time Frame

These data will be shared after the investigators have published the specific aims of this study. Requests for the code used to create CarePair will be reviewed by the investigative team and shared once feasibility, acceptability, and preliminary efficacy has been examined and the findings have been published.

IPD Sharing Access Criteria

Individuals who wish to access the data are required to: 1) Use the data for research purposes only; 2) Not identify any individual participant; 3) Secure the data using appropriate computer technology such as password-protected servers and files; and 4) Return and/or destroy data after analyses are complete.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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