CommunityRx-Dementia

Study Overview
=================
Brief 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 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).

Official Title
-----------------
CommunityRx-Dementia: A Study for Primary Caregivers of Loved Ones With Alzheimer's Disease and Related Dementias

Conditions
-----------------
Health Related Social Needs (HRSN)

Intervention / Treatment
-----------------
* Behavioral: Community Rx-Dementia CRxD Caregiver Resources


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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) Exclusion Criteria: Past enrollment in the CommunityRx-C study Recollection of previous receipt of a HealtheRx

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cases<br>Community Rx-Dementia CRxD Caregiver Resources | Behavioral: Community Rx-Dementia CRxD Caregiver Resources<br>* A tailored list of resources addressing health-related social needs (HRSN) for caregivers and access to an online community resource finder.<br>* Other names: CRx-D;|
| No Intervention: Control<br>Usual Standard Care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in caregiver self-efficacy | 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. | Baseline, 7 days, 30 days, 90 days, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
caregivers, dementia, information-sharing, Alzheimer's Disease, caregiving, community resources