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Completed

NCT Number: NCT04146545

CommunityRx-Dementia

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.

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Key information

Conditions

Health Related Social Needs (HRSN) Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago

Chicago, Illinois, 60637, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: CRx-D

Primary outcomes

  1. 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

  2. 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).

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

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

Acronym: CRx-D

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2019
Registry last updated
Apr 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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