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

Overview

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.

Interventions

• 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.

Primary outcome measures

• 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 as measured by the proportion of family caregivers who consent to participate and are enrolled. [Time frame: 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 as measured by recruitment rates and the proportion of family caregivers that decline participation. [Time frame: Enrollment]
• 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]
• 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]
• 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 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]
• Application Usability, as measured using the validated System Usability Scale (SUS). [Time frame: 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]

Secondary outcome measures (6)

• Change from Baseline Caregiver Needs scores on a 12-item Needs Assessment [Time frame: Baseline; 6-Week Follow-Up]
• Change from Baseline Caregiving Self-Efficacy scores on the 15-item Revised Scale for Caregiving Self-Efficacy [Time frame: 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]
• Change from Baseline Anxiety scores on the Generalized Anxiety Disorder-7 (GAD-7) [Time frame: 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]
• Change from Baseline Quality of Life scores on the 5-item Satisfaction with Life Scale (SWLS) [Time frame: Baseline; 6-Week Follow-Up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Supportive care

Study locations

United States · 1 center

• University of Southern California — Los Angeles

Identifiers

NCT: NCT06418971 · UP-25-00690 · R00AG073509

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗