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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
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

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

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
October 29, 2019
Last Updated
July 6, 2023
Sponsor
University of Chicago
Collaborators
National Institute on Aging (NIA)
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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

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