The Caregiver Resource Room (CRR): Using Technology to Enhance Support for Dementia Family Caregivers

Dementia Clinical Trial

— CRR  

Official title:

The Caregiver Resource Room: Using Technology to Enhance Support for Caregivers of Alzheimer's Disease and Related Dementias

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06418971
• Other study ID #: UP-23-00768
• Secondary ID: R00AG073509
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 1, 2025
• Est. completion date: August 31, 2026

Study information

• Verified date: May 2024
• Source: University of Southern California
• Contact: Francesca B Falzarano, PhD
• Phone: 6464812858
• Email: falzaran[@]usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to develop and test CarePair, a web-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 web application.

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

Caregiver participants will be asked to log in and test the CarePair web application and complete study activities for a three-month 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.

Description:

In 2023, approximately 6.7 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 web-based 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: August 31, 2026
• Est. primary completion date: August 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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 exhibit cognitive impairment (e.g., scoring below 3 on the Short Portable Mental Status Questionnaire, SPMSQ)

Exclusion Criteria:

• Not a primary caregiver to a community-dwelling person with dementia (PwD)

• Under 18-years-old,

• Does not speak English

• Evidence of cognitive impairment

Related Conditions & MeSH terms

• Caregiver Burden
• Caregiver Burnout
• Dementia

Intervention

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.

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participant Engagement, as Measured By Number of Application Logins Per Participant	The platform's built-in analytics will measure engagement via number of application logins per participant to assess participant engagement as an assessment of feasibility.	3 Month Follow-Up
Primary	Rates of Participant Satisfaction with Intervention and Web Application, as Measured by Post-Intervention Feedback	Five items will be administered to measure satisfaction with the intervention and web application across the following domains: 1) Overall Satisfaction; 2) Ease of Use; 3) Content Quality; 4) Design and Aesthetics; 5) Purpose Fulfillment. Responses are reported on a Likert scale ranging from 1 (not at all satisfied) to 5 (very satisfied). Total scores range from 5-25, with higher scores reflecting greater levels of participant satisfaction. Satisfaction will be evaluated based on a) the percentage of participants who report being "satisfied" or "very satisfied" with the intervention and web application, as well as b) open-ended feedback regarding the components of the application and intervention perceived to be of the most value/benefit; and c) likelihood and/or willingness to use the application in the future.	3 Month Follow-Up
Primary	Web Application Usability, as measured using the validated System Usability Scale (SUS).	Usability and accessibility of the web 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.	3 Month Follow-Up
Secondary	Change from Baseline Caregiving Self-Efficacy scores on the 15-item Revised Scale for Caregiving Self-Efficacy at 4 Weeks.	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; 3-Month Follow-Up
Secondary	Change from Baseline Caregiver Burden scores as measured by the validated 12-item Zarit Burden Inventory (ZBI-12).	The Zarit Burden Inventory (ZBI-12) will be used to measure family caregiver burden. Total scores range from 0-48, with higher scores indicative of greater burden.	Baseline; 3-Month Follow-Up
Secondary	Change from Baseline Caregiver Depressive Symptoms as measured by the validated Patient Health Questionnaire-9 (PHQ-9).	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; 3-Month Follow-Up