Clinical trial NCT06418971: Testing & Refinement of CarePair: An Assessment and Referral Platform to Support Family Caregivers of Alzheimer's Disease and Related Dementias.
Official title: Testing & Refinement of CarePair: An Assessment and Referral Platform to Support Family Caregivers of Alzheimer's Disease and Related Dementias.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Caregiver Burden
Caregiver Burnout
Dementia
Keywords: Dementia family caregivers
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2024-05-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Primary caregiver of a community-dwelling person with dementia (PwD)
* Greater or equal to 18 years of age
* Able to use the internet and has internet access
* English-speaking
* Does not self-report cognitive impairment
* Has been a caregiver for at least 6 months
* Provides care for at least 10 hours per week

Exclusion Criteria:

* Not a primary caregiver to a community-dwelling person with dementia (PwD)
* Under 18-years-old
* Does not speak English
* Self reports a cognitive impairment
* Has been a caregiver for less than 6 months
* Provides less than 10 hours of care per week

Primary outcomes:
measure: Participant Engagement, as Measured By Number of Application Logins Per Participant
timeFrame: 6-Week Follow-Up
measure: Rates of Participant Satisfaction with Intervention and Web Application, as Measured by Post-Intervention Feedback
timeFrame: 6-Week Follow-Up
measure: Web Application Usability, as measured using the validated System Usability Scale (SUS).
timeFrame: 6-Week Follow-Up
Secondary outcomes:
measure: Change from Baseline Caregiving Self-Efficacy scores on the 15-item Revised Scale for Caregiving Self-Efficacy
timeFrame: Baseline; 6-Week Follow-Up
measure: Change from Baseline Caregiver Burden scores as measured by the validated 12-item Zarit Burden Inventory (ZBI-12).
timeFrame: Baseline; 6-Week Follow-Up
measure: Change from Baseline Caregiver Depressive Symptoms as measured by the validated Patient Health Questionnaire-9 (PHQ-9).
timeFrame: Baseline; 6-Week Follow-Up
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of Southern California
state: California
Study officials:
affiliation: University of Southern California
name: Francesca Falzarano, PhD
role: PRINCIPAL_INVESTIGATOR
References: