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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01AG064949-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cases | Experimental | Community Rx-Dementia "CRxD" Caregiver Resources |
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| Control | No Intervention | Usual Standard Care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Community Rx-Dementia "CRxD" Caregiver Resources | Behavioral | A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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). | 7 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago | Chicago | Illinois | 60637 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37864258 | Derived | Abramsohn 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. | |
| 36909590 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cases | Community Rx-Dementia "CRxD" Caregiver Resources Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder. |
| FG001 | Control | Usual Standard Care |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Includes all participants except for 1 who was deemed ineligible after randomization
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| ID | Title | Description |
|---|---|---|
| BG000 | Cases - Main Randomized Trial | Community Rx-Dementia "CRxD" Caregiver Resources, Enrolled as part of the Main Randomized Trial Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Analysis was restricted to caregivers in the main randomized trial who had at least 1 unmet health-related social need at baseline and completed the self-efficacy measure at 12 month follow-up | Posted | Mean | Standard Deviation | score on a scale | 12 months |
|
12 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cases | Community Rx-Dementia "CRxD" Caregiver Resources Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emily Abramsohn | University of Chicago | 7738344832 | eabramsohn@bsd.uchicago.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 30, 2023 | Mar 18, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 17, 2025 | Mar 18, 2025 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Oct 17, 2022 | Mar 18, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D003704 | Dementia |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D019965 | Neurocognitive Disorders |
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Cases will receive the CRx-D Intervention. Controls will not receive the intervention but will receive the usual standard of care.
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| Abramsohn 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. |
| Control - Main Randomized Trial |
Usual Standard Care - Enrolled as part of the Main Randomized Trial |
| BG002 | Cases - Supplement | Community Rx-Dementia "CRxD" Caregiver Resources, Enrolled as part of the Supplement Community Rx-Dementia "CRxD" Caregiver Resources: A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder. |
| BG003 | Control - Supplement | Usual Standard Care - Enrolled as part of the Supplement |
| BG004 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Number analyzed differs from overall due to missing data | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number analyzed differs from overall due to missing data | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Presence of at least 1 health-related social risk factor | Presence of at least one health-related social risk factor (HRSR) at baseline based on the Accountable Health Communities screening tool, including food, housing, transportation, utilities, and safety. Standard scoring guidelines were used and participants' baseline HRSR status was categorized as none versus one or more HRSRs. | Count of Participants | Participants |
|
| OG001 | Control | Usual Standard Care |
|
|
| Primary | 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). | Analysis was restricted to caregivers in the main randomized trial who completed the satisfaction measure at 1 week follow-up | Posted | Mean | Standard Deviation | score on a scale | 7 days |
|
|
|
| 0 |
| 177 |
| 0 |
| 177 |
| 0 |
| 177 |
| EG001 | Control | Usual Standard Care | 0 | 182 | 0 | 182 | 0 | 182 |
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| D001523 | Mental Disorders |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| Male |
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| One or more |
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