Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 29, 2019
First Posted Date  ICMJE October 31, 2019
Last Update Posted Date April 29, 2020
Actual Study Start Date  ICMJE December 16, 2019
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2019)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE CommunityRx for Caregivers
Official Title  ICMJE CommunityRx for Caregivers: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Health Related Social Needs (HRSN)
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Cases
    Community Rx-Caregiver Resources
    Intervention: Behavioral: Community Rx-Caregiver Resources
  • No Intervention: Control
    Usual Standard Care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 29, 2019)
364
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 1, 2023
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04146545
Other Study ID Numbers  ICMJE IRB19-0430
1R01AG064949-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Chicago
Study Sponsor  ICMJE University of Chicago
Collaborators  ICMJE National Institute on Aging (NIA)
Investigators  ICMJE Not Provided
PRS Account University of Chicago
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP