CommunityRx-Dementia + Peer Navigation (CRxDpeer)

NCT ID: NCT07346183

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2029-02-28

Brief Summary

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.

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 diversity 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.

Conditions

Alzheimer s Disease; Dementia; Caregiver; Loneliness; Health-Related Social Needs; Social Care; Healthcare Utilization; End of Life Care; Caregiver Burden; Anxiety; Stress; Depression; Self-Efficacy; Peer Support; Implementation Science; Advance Care Planning

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: DOUBLE

Study Groups

Cases

Usual care + CommunityRx-Dpeer

Group Type: EXPERIMENTAL

CommunityRx-Dpeer

Intervention Type: OTHER

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.

Control

Usual Standard Care

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

CRxDpeer

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

University of Chicago

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Ifeoluwadolapo Ojewuyi, MPH

Role: CONTACT

ifeoluwadolapo.ojewuyi@bsd.uchicago.edu

773-704-9724

References

Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.

Reference Type: BACKGROUND

PMID: 18504506 (View on PubMed)

Other Identifiers

R01AG091308

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB25-1341

Identifier Type: -

Identifier Source: org_study_id