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CommunityRx for Caregivers (CRx-C)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04146545
Recruitment Status : Enrolling by invitation
First Posted : October 31, 2019
Last Update Posted : April 29, 2020
Sponsor:
Collaborator:
National Institute on Aging (NIA)
Information provided by (Responsible Party):
University of Chicago

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-C intervention versus usual care on caregiver self-efficacy.

Condition or disease Intervention/treatment Phase
Health Related Social Needs (HRSN) Behavioral: Community Rx-Caregiver Resources Not Applicable

Detailed Description:
The CRx-C 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 3 designated 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 364 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Cases will receive the CRx-C Intervention. Controls will not receive the intervention but will receive the usual standard of care.
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: CommunityRx for Caregivers: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias
Actual Study Start Date : December 16, 2019
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : February 1, 2023


Arm Intervention/treatment
Experimental: Cases
Community Rx-Caregiver Resources
Behavioral: Community Rx-Caregiver Resources
A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
Other Name: CRx-C

No Intervention: Control
Usual Standard Care



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Resides in the target geographic region of the study (living in 1 of the 27 target zip codes)
  • Speaks/Reads English
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04146545


Locations
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United States, Illinois
University of Chicago
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
National Institute on Aging (NIA)
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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT04146545    
Other Study ID Numbers: IRB19-0430
1R01AG064949-01 ( U.S. NIH Grant/Contract )
First Posted: October 31, 2019    Key Record Dates
Last Update Posted: April 29, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Chicago:
caregivers
dementia
information-sharing
Alzheimer's Disease
caregiving
community resources