CommunityRx-Dementia (CRx-D)
Primary Purpose
Health Related Social Needs (HRSN)
Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Community Rx-Dementia "CRxD" Caregiver Resources
Sponsored by
About this trial
This is an interventional health services research trial for Health Related Social Needs (HRSN) focused on measuring caregivers, dementia, information-sharing, Alzheimer's Disease, caregiving, community resources
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
Exclusion Criteria:
- Past enrollment in the CommunityRx-C study
- Recollection of previous receipt of a HealtheRx
Sites / Locations
- University of Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cases
Control
Arm Description
Community Rx-Dementia "CRxD" Caregiver Resources
Usual Standard Care
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04146545
First Posted
October 29, 2019
Last Updated
July 6, 2023
Sponsor
University of Chicago
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT04146545
Brief Title
CommunityRx-Dementia
Acronym
CRx-D
Official Title
CommunityRx-Dementia: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
December 16, 2019 (Actual)
Primary Completion Date
February 28, 2024 (Anticipated)
Study Completion Date
February 28, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Health Related Social Needs (HRSN)
Keywords
caregivers, dementia, information-sharing, Alzheimer's Disease, caregiving, community resources
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Cases will receive the CRx-D Intervention. Controls will not receive the intervention but will receive the usual standard of care.
Masking
Participant
Allocation
Randomized
Enrollment
364 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cases
Arm Type
Experimental
Arm Description
Community Rx-Dementia "CRxD" Caregiver Resources
Arm Title
Control
Arm Type
No Intervention
Arm Description
Usual Standard Care
Intervention Type
Behavioral
Intervention Name(s)
Community Rx-Dementia "CRxD" Caregiver Resources
Other Intervention Name(s)
CRx-D
Intervention Description
A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
Primary Outcome Measure Information:
Title
Change from baseline in caregiver self-efficacy
Description
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.
Time Frame
Baseline, 7 days, 30 days, 90 days, 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
12. IPD Sharing Statement
Learn more about this trial
CommunityRx-Dementia
We'll reach out to this number within 24 hrs