Health Related Social Needs (HRSN)CRx-DNCT04146545
CommunityRx-Dementia
A study testing Community Rx-Dementia "CRxD" Caregiver Resources in people with Health Related Social Needs (HRSN), run by University of Chicago at 1 site in United States.
Trial 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-D intervention versus usual care on caregiver… Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Health Related Social Needs (HRSN)
- What is being tested?
- Community Rx-Dementia "CRxD" Caregiver Resources
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2019to 19 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Resides in the target geographic region of the study (living in 1 of the 35 target zip codes)
- 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
- Has a personal email address.
- Self-report their gender identity to be male or trans male/trans man (only for additional 50 caregivers enrolled in the 3-month RCT)
Who cannot join
- Past enrollment in the CommunityRx-C study
- Recollection of previous receipt of a HealtheRx
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CommunityRx-Dementia: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias
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-D intervention versus usual care on caregiver self-efficacy.
Read the detailed description
The CRx-D 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 UChicago-affiliated 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.
The anticipated sample (n=414) includes pretest participants (n=20), RCT participants enrolled in the 12-month RCT (n=344) and additional men caregivers enrolled in a 3-month RCT (N=50).
- Conditions
- Health Related Social Needs (HRSN)
- Being tested
- Community Rx-Dementia "CRxD" Caregiver Resources
- Keywords
- caregivers, dementia, information-sharing, Alzheimer's Disease, caregiving, community resources
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community Rx-Dementia "CRxD" Caregiver ResourcesBehavioural
Also called CRx-D
A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Experimental | Community Rx-Dementia "CRxD" Caregiver Resources Receives: Behavioral: Community Rx-Dementia "CRxD" Caregiver Resources |
| Control | No intervention | Usual Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs
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. Higher values = greater self-efficacy
Measured: 12 months
Satisfaction With Care
Satisfaction will be assessed using the Patient Satisfaction Questionnaire 18-item short form (PSQ-18), specifically the general satisfaction sub-scale (2 questions). Five possible response options for each of the two items are scored 1 to 5; with a higher score equating to higher satisfaction. Scores will be transformed using the formula: y= 100 * (x-a)/(b-a) where y=the transformed score, x=the original score, a=the minimum possible score and b=the maximum possible score. Transformed items will be averaged to generate the composite score (range 0-100; higher scores indicating greater satisfaction).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2019
- Study start16 Dec 2019
- Primary completion19 Mar 2024
- Study completion19 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Health Related Social Needs (HRSN)Studies 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 CRx-D Intervention. Controls will not receive the intervention but will receive the usual standard of care.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 360 participants (actual)
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
- NCT04146545
- Sponsor's protocol ID
- IRB20-0301
- Other IDs
- 1R01AG064949-01
- Acronym
- CRx-D
- Status last verified
- Jul 2026
- First submitted
- 29 Oct 2019
- Last updated
- 7 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Winslow VA, Lindau ST, Huang ES, Asay S, Johnson AE, Borson S, Thompson K, Makelarski JA. Caring for dementia caregivers: How well does social risk screening reflect unmet needs? J Am Geriatr Soc. 2025 Jan;73(1):63-73. doi: 10.1111/jgs.19200. Epub 2024 Sep 24.
PubMed 39315491Makelarski JA, Wroblewski KE, Winslow VA, Abramsohn EM, Borson S, Romanchick DA, Schulman-Green D, Thompson K, Huang ES, Lindau ST. Low-Intensity Social Care for Dementia Caregivers: A Randomized Trial. J Am Geriatr Soc. 2026 Oct 13. doi: 10.1111/jgs.70684. Online ahead of print.
PubMed 42869650Abramsohn EM, De Ornelas M, Borson S, Frazier CRM, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials. Trials. 2023 Oct 21;24(1):681. doi: 10.1186/s13063-023-07697-z.
PubMed 37864258Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1.
PubMed 36909590
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CommunityRx-Dementia: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias
- ClinicalTrials.gov ID
- NCT04146545
- Acronym / sponsor ID
- CRx-D / IRB20-0301
- Conditions
- Health Related Social Needs (HRSN)
- Keywords
- caregivers, dementia, information-sharing, Alzheimer's Disease, caregiving, community resources
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 16 Dec 2019 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 19 Mar 2024 (actual)
- First posted
- 31 Oct 2019 (actual)
- Results
- Posted 3 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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-D intervention versus usual care on caregiver self-efficacy.
Detailed description
The CRx-D 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 UChicago-affiliated 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.
The anticipated sample (n=414) includes pretest participants (n=20), RCT participants enrolled in the 12-month RCT (n=344) and additional men caregivers enrolled in a 3-month RCT (N=50).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Cases will receive the CRx-D Intervention. Controls will not receive the intervention but will receive the usual standard of care.
| Arm | Type | Receives |
|---|---|---|
| Cases | Experimental | Behavioral: Community Rx-Dementia "CRxD" Caregiver ResourcesCommunity Rx-Dementia "CRxD" Caregiver Resources |
| Control | No intervention | –Usual Standard Care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Resides in the target geographic region of the study (living in 1 of the 35 target zip codes)
- 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
- Has a personal email address.
Key exclusion criteria (2 listed)
- Past enrollment in the CommunityRx-C study
- Recollection of previous receipt of a HealtheRx
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 |
|---|---|---|
| Community Rx-Dementia "CRxD" Caregiver ResourcesAlso: CRx-DA tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder. | Behavioural | Cases |
Primary outcome
Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs
Time frame: 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. Higher values = greater self-efficacy
Satisfaction With Care
Time frame: 7 days
Satisfaction will be assessed using the Patient Satisfaction Questionnaire 18-item short form (PSQ-18), specifically the general satisfaction sub-scale (2 questions). Five possible response options for each of the two items are scored 1 to 5; with a higher score equating to higher satisfaction. Scores will be transformed using the formula: y= 100 * (x-a)/(b-a) where y=the transformed score, x=the original score, a=the minimum possible score and b=the maximum possible score. Transformed items will be averaged to generate the composite score (range 0-100; higher scores indicating greater satisfaction).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 39315491Winslow VA, Lindau ST, Huang ES, Asay S, Johnson AE, Borson S, Thompson K, Makelarski JA. Caring for dementia caregivers: How well does social risk screening reflect unmet needs? J Am Geriatr Soc. 2025 Jan;73(1):63-73. doi: 10.1111/jgs.19200. Epub 2024 Sep 24.
- Derived from this study: PubMed 42869650Makelarski JA, Wroblewski KE, Winslow VA, Abramsohn EM, Borson S, Romanchick DA, Schulman-Green D, Thompson K, Huang ES, Lindau ST. Low-Intensity Social Care for Dementia Caregivers: A Randomized Trial. J Am Geriatr Soc. 2026 Oct 13. doi: 10.1111/jgs.70684. Online ahead of print.
- Derived from this study: PubMed 37864258Abramsohn EM, De Ornelas M, Borson S, Frazier CRM, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. CommunityRx, a social care assistance intervention for family and friend caregivers delivered at the point of care: two concurrent blinded randomized controlled trials. Trials. 2023 Oct 21;24(1):681. doi: 10.1186/s13063-023-07697-z.
- Derived from this study: PubMed 36909590Abramsohn EM, De Ornelas M, Borson S, Frazier CR, Fuller CM, Grana M, Huang ES, Jagai JS, Makelarski JA, Miller D, Schulman-Green D, Shiu E, Thompson K, Winslow V, Wroblewski K, Lindau ST. Two concurrent randomized controlled trials of CommunityRx, a social care intervention for family and friend caregivers delivered at the point of care. Res Sq [Preprint]. 2023 Mar 1:rs.3.rs-2464681. doi: 10.21203/rs.3.rs-2464681/v1.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Community Rx-Dementia "CRxD" Caregiver Resources in people with Health Related Social Needs (HRSN), 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 6 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: finished, as of the sponsor's last update on 7 Aug 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?
Yes. Results are posted in the registry (first posted 3 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caregiver Self-efficacy at 12 Months Among Caregivers With Unmet Health Related Social Needs (time frame: 12 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 NCT04146545, which also lists 4 linked publications.
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 7 Aug 2026.