CommunityRx-Dementia + Peer Navigation (CRxDpeer) (CRxDpeer)

April 6, 2026 updated by: University of Chicago

CommunityRx-Dementia + Peer Navigation (CRxDpeer): A Real-World Implementation and Effectiveness Study of an IT-Based Social Care Intervention

The CRxDpeer intervention, delivered by a trained peer navigator, in practice called a "peer mentor", includes three evidence-based components: (a) focused education about common social (e.g., food and housing insecurity) and caregiving (e.g., respite and end of life care) needs, (b) activation of personalized community resource information for social and caregiving needs through delivery of a resource list (HealtheRx) at the baseline encounter and coaching on how to communicate with service providers, coordinate services and manage social support (e.g., connect with their peer navigator, reach out to friends or relatives for support, identify support groups, etc.) and (c) ongoing navigation-focused support meant to boost the baseline intervention, including a series of proactive text messages over 12 months. During this time, the subject can respond to and communicate with the peer navigator for ongoing support.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

In 2022, more than 11 million Americans, half of whom were 50 or older, provided more than 18 billion hours of unpaid care for people with dementia. Many caregivers have no formal training and limited support. The White House, along with the Alzheimer's Association, the National Institute on Aging and others, is calling for urgent attention to the health and well-being of the fast-growing population of dementia caregivers, with heightened concern for caregivers living in historically marginalized communities. Scalable, evidence-based, solutions leveraging existing assets are urgently needed to meaningfully reach all caregivers. Our approach to addressing these unmet needs, CommunityRxDpeer, is an information technology-based, low-intensity, health system-initiated community resource navigation intervention delivered to caregivers by peer caregiver navigators remotely over time. Essential components include education about common social, including caregiving needs, activation of personalized community resource information and ongoing navigation-focused support. The CRxDpeer intervention components are informed by evidence-based "processes" identified in the Grey et al. Self- and Family Management Framework that are known to promote desirable health outcomes among people living or caring for others with chronic health conditions, including dementia. Prior CommunityRx trials have successfully deployed community members, clinicians and researchers to deliver the intervention in real-world and research settings with positive outcomes in a wide-range of populations. In this pragmatic trial, experienced and willing dementia caregivers from the CRxDementia cohort (2020-24) will be recruited and trained as peer navigators to deliver CRxDpeer. Using a hybrid effectiveness implementation design with a double-blind RCT, we will evaluate the effectiveness of CRxDpeer versus usual care on caregiver health and well-being, healthcare utilization and social care outcomes. In parallel, we will evaluate the adoption, fidelity and cost of CRxDpeer and, using mixed methods, characterize perceived mechanisms of impact on caregivers delivering and receiving CRxDpeer. The specific objectives are to demonstrate that CRxDpeer can be delivered in the real world with fidelity and to assess the effectiveness of this approach on important outcomes. Resource referral and peer support IT platforms deployed for intervention delivery are already in commercial use, paving a viable path to replication and scale as a stand-alone or adjunct to other caregiver interventions, like the Center for Medicare & Medicaid Guiding an Improved Dementia Experience (GUIDE) Model test, which aims to enable people with dementia to age at home by supporting family caregivers with education and resources. CRxDpeer has the potential to improve the health and well-being of millions of dementia caregivers and their care recipients by meaningfully connecting them to vital social and caregiving resources and creating opportunity for willing and experienced caregivers to support with others.

Study Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Self-identifies as a caregiver of a home-dwelling person with Alzheimer's disease or related dementias (ADRD)
  • Resides in the target geographic region of the study
  • Has access to a cell phone and agrees to receive text messages from the study
  • Has an email address that they can receive emails from
  • Individuals under the age of 18 who are emancipated minors in the state of Illinois and a caregiver of a person with dementia

Exclusion Criteria:

  • Minors who are not emancipated in the state of Illinois.
  • Previously participated in the intervention arm of the CommunityRx-Dementia clinical trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Usual Standard Care
Experimental: Cases
Usual care + CommunityRx-Dpeer
Other: CommunityRx-Dpeer
Essential components of the CRxDpeer intervention include: (1) focused education about common social (e.g. food, housing, transportation) and, specifically, caregiving needs (e.g. caregiver education, stress management, End of Life/Advance Care Planning (EOL/ACP)) and related resources, (2) activation of community resources through delivery of and coaching on use of a personalized local referral list (a "HealtheRx") and (3) boosting through a series of automated proactive text messages and ongoing resource navigational support by text/phone/email/video for utilizing resources. This intervention will be delivered by a peer mentor who is experienced in dementia caregiving and trained to provide 1:1 peer mentorship and resource navigation to dementia caregivers.
Other Names:
  • CRxDpeer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caregiver loneliness at 6 months
Time Frame: 6 months
Loneliness is measured using the 3-item UCLA Loneliness Scale (Hughes et al. 2004). Responses to each of the items are scored 1= "Hardly ever", 2= "Some of the time", or 3= "Often". A total score is generated by summing the individual items, with a possible range of 3-9 and higher scores = greater loneliness.
6 months
Caregiver's self-efficacy for finding end of life/advance care planning resources for the person with dementia at 12 months
Time Frame: 12 months
Self-efficacy is measured using a single item question developed for this study: "How confident are you that you can find resources to help [name of care recipient] put into writing their medical wishes if they were very sick or near the end of their life?". Responses are measured on a 4-point scale of 1="Not at all confident", 2="Not very confident", 3="Somewhat confident", or 4="Completely confident" [higher score = greater self-efficacy].
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Chicago

Collaborators

National Institute on Aging (NIA)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

February 28, 2029

Study Completion (Estimated)

February 28, 2029

Study Registration Dates

First Submitted

January 14, 2026

First Submitted That Met QC Criteria

January 14, 2026

First Posted (Actual)

January 16, 2026

Study Record Updates

Last Update Posted (Actual)

April 7, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB25-1341
  • R01AG091308 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

In the interval since submission of our funding application, artificial intelligence (AI) capabilities and its application by the research community and the public more generally have evolved rapidly. In this context, we are re-examining our data sharing plan to optimize for both sharing and protection of human subjects against a potentially higher risk of deductive disclosure. We do plan to share de-identified data, or limited datasets, with researchers under approved IRB protocols.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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