CommunityRx-Dementia

Health Related Social Needs (HRSN) Clinical Trial

— CRx-D  

Official title:

CommunityRx-Dementia: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04146545
• Other study ID #: IRB20-0301
• Secondary ID: 1R01AG064949-01
• Status: Enrolling by invitation
• Phase: N/A
• Start date: December 16, 2019
• Est. completion date: February 28, 2024

Study information

• Verified date: July 2023
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Caregivers of home-dwelling people with Alzheimer's Disease and related dementias (ADRD) are one of the most rapidly growing populations in the United States. Among ADRD caregivers with unmet health-related social needs, this study aims to evaluate the effects of the CRx-D intervention versus usual care on caregiver self-efficacy.

Description:

The CRx-D intervention is a caregiver-centered adaptation of CommunityRx (CRx), an information-based intervention that systematically matches people to nearby community resources for health-related social needs. We are conducting a single-blind randomized controlled trial and enrolling caregivers through UChicago-affiliated clinic sites. Caregivers will be screened and asked about unmet health-related social needs at the outpatient visit. Eligible, self-identified caregivers will complete an in-person baseline survey on-site (face to face), followed by phone surveys at 7, 30, 90 days, and 12 months. Caregivers randomized to the intervention will receive tailored information on community resources for their identified health-related social needs. They will also be given access to an online community-resource tool and shown how to use it, so they can search for additional resources in their community beyond the point-of-care and outside of the clinic. All caregivers (regardless of research arm) will also receive a series of text messages related to the study such as reminders to schedule the phone survey with a member of the research team.

The anticipated sample (n=414) includes pretest participants (n=20), RCT participants enrolled in the 12-month RCT (n=344) and additional men caregivers enrolled in a 3-month RCT (N=50).

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 364
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• Resides in the target geographic region of the study (living in 1 of the 35 target zip codes)

• Self-identifies as a caregiver of a home-dwelling person with Alzheimer's Disease or related dementia using an adaptation of the BRFSS caregiver module

• Has access to a cell phone and provides the research interviewer with the cell phone number

• Agrees to receive text messages from the study

• Has a personal email address.

• Self-report their gender identity to be male or trans male/trans man (only for additional 50 caregivers enrolled in the 3-month RCT)

Exclusion Criteria:

• Past enrollment in the CommunityRx-C study

• Recollection of previous receipt of a HealtheRx

Related Conditions & MeSH terms

• Dementia
• Health Related Social Needs (HRSN)

Intervention

Behavioral:
• Community Rx-Dementia "CRxD" Caregiver Resources
A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.

Locations

Country	Name	City	State
United States	University of Chicago	Chicago	Illinois

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in caregiver self-efficacy	Self-efficacy is measured with a 4-item sub-domain from the 2015 Caregiver Dementia Care and Self-Efficacy Survey (Jennings et al). Responses to each of the items are scored between 1 = "strongly disagree" to 5 = "strongly agree" and will generate an average score.	Baseline, 7 days, 30 days, 90 days, 12 months