- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04146545
CommunityRx-Dementia (CRx-D)
CommunityRx-Dementia: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60637
- University of Chicago
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Usual Standard Care
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Experimental: Cases
Community Rx-Dementia "CRxD" Caregiver Resources
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A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in caregiver self-efficacy
Time Frame: Baseline, 7 days, 30 days, 90 days, 12 months
|
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
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB20-0301
- 1R01AG064949-01 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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