Alzheimer s DiseaseCRxDpeerNCT07346183
CommunityRx-Dementia + Peer Navigation (CRxDpeer)
A study testing CommunityRx-Dpeer in people with Alzheimer s Disease and Dementia, run by University of Chicago at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer s Disease, Dementia, Caregiver
- What is being tested?
- CommunityRx-Dpeer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Oct 2026to 28 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Minors who are not emancipated in the state of Illinois.
- Previously participated in the intervention arm of the CommunityRx-Dementia clinical trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Chicago
Chicago, Illinois, 60637
Mellissa Grana, Bachelors of Arts, 7738343700, mgrana@bsd.uchicago.edu
Ife Ojewuyi, MPH, Ifeoluwadolapo.ojewuyi@bsd.uchicago.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Alzheimer s Disease, Dementia, Caregiver, Loneliness, Health-Related Social Needs, Social Care
- Being tested
- CommunityRx-Dpeer
- Keywords
- resource navigation, peer navigator, peer mentor, social care, dementia caregiver
- Medical subject headings
- Dementia, Caregiver Burden, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CommunityRx-DpeerOther
Also called CRxDpeer
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.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | Usual care + CommunityRx-Dpeer Receives: Other: CommunityRx-Dpeer |
| Control | No intervention | Usual Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver loneliness at 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.
Measured: 6 months
Caregiver's self-efficacy for finding end of life/advance care planning resources for the person with dementia at 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].
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
- Study start5 Oct 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cases will receive the CRxDpeer intervention plus usual care. Controls will not receive the intervention, but will receive the usual standard of care.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346183
- Sponsor's protocol ID
- IRB25-1341
- Other IDs
- R01AG091308
- Acronym
- CRxDpeer
- Status last verified
- Oct 2026
- First submitted
- 14 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: 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.
Publications
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.
PubMed 18504506
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CommunityRx-Dementia + Peer Navigation (CRxDpeer): A Real-World Implementation and Effectiveness Study of an IT-Based Social Care Intervention
- ClinicalTrials.gov ID
- NCT07346183
- Acronym / sponsor ID
- CRxDpeer / IRB25-1341
- Conditions
- Alzheimer s Disease, Dementia, Caregiver, Loneliness, Health-Related Social Needs, Social Care
- Keywords
- resource navigation, peer navigator, peer mentor, social care, dementia caregiver
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 5 Oct 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2029 (estimated)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Cases will receive the CRxDpeer intervention plus usual care. Controls will not receive the intervention, but will receive the usual standard of care.
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Other: CommunityRx-DpeerUsual care + CommunityRx-Dpeer |
| Control | No intervention | –Usual Standard Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Minors who are not emancipated in the state of Illinois.
- Previously participated in the intervention arm of the CommunityRx-Dementia clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CommunityRx-DpeerAlso: CRxDpeerEssential 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 | Cases |
Primary outcome
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.
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].
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Background: PubMed 18504506Hughes 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.
- Individual participant dataSharing planned: Undecided. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CommunityRx-Dpeer in people with Alzheimer s Disease and Dementia, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ifeoluwadolapo Ojewuyi, MPH (773-704-9724, ifeoluwadolapo.ojewuyi@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver loneliness at 6 months (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07346183, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.