Clinical trial NCT04146545: CommunityRx-Dementia
Official title: CommunityRx-Dementia: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Related Social Needs (HRSN)
Keywords: caregivers
dementia
information-sharing
Alzheimer's Disease
caregiving
community resources
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2019-10-31
Enrollment: 360
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cases will receive the CRx-D Intervention. Controls will not receive the intervention but will receive the usual standard of care.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs
timeFrame: 12 months
measure: Satisfaction With Care
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
Study officials:
References: