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

NCT06418971 | Recruiting

• 2 other identifiers: UP-25-00690R00AG073509
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden; Caregiver Burnout; Dementia

Keywords

Dementia family caregivers

Outcome Measures

Primary Outcomes (12)

• The Feasibility of the CarePair study as measured by the proportion of family caregivers who complete the study screening survey.

  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.

  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.

  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.

  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 participants lost to 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 Feasibility of the CarePair study as measured by participant retention, as indicated by the number of recorded dropouts.

  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).

  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

• The Feasibility of the CarePair application as measured by the number of app interactions per participant out of total required (minimum= 12).

  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

• Application Usability, as measured using the validated System Usability Scale (SUS).

  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).

  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 Acceptability of the CarePair application as measured by a survey that measures the participants satisfaction and acceptability of the application.

  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.

  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

Secondary Outcomes (6)

• Change from Baseline Caregiver Needs scores on a 12-item Needs Assessment

  Baseline; 6-Week Follow-Up

• Change from Baseline Caregiving Self-Efficacy scores on the 15-item Revised Scale for Caregiving Self-Efficacy

  Baseline; 6-Week Follow-Up

• Change from Baseline Caregiver Depressive Symptoms as measured by the Patient Health Questionnaire-9 (PHQ-9).

  Baseline; 6-Week Follow-Up

• Change from Baseline Anxiety scores on the Generalized Anxiety Disorder-7 (GAD-7)

  Baseline; 6-Week Follow-Up

• Change from Baseline Caregiver Stress as measured by the Kingston Caregiver Stress Scale (KCSS)

  Baseline; 6-Week Follow-Up

Study Arms (2)

Control Arm

NO INTERVENTION

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.

CarePair Intervention Arm

EXPERIMENTAL

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

Interventions

CarePair 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.

CarePair Intervention Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Southern California

Los Angeles, California, 90089, United States

RECRUITING

MeSH Terms

Conditions

Caregiver Burden; Dementia

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Francesca Falzarano, PhD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca B Falzarano, PhD

CONTACT

6464812858; falzaran@usc.edu

Annabelle V Greenfield, BS

CONTACT

6467809506; ag69282@usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 27, 2024
• First Posted: May 17, 2024
• Study Start: September 15, 2025
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• 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.
• 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.

Locations

US (1)