Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the Emergency Department (CarES)

Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the ED

Care partners of people living with dementia often experience ongoing stress and unmet support needs. This study evaluates the feasibility of a low-intensity, supportive education and resource intervention for care partners who previously participated in an observational study.

Participants complete a baseline phone interview and a short stress journaling activity, followed by a six-week series of automated educational and supportive messages delivered by text message or email. Participants may also take part in an optional peer support focus group. The study examines caregiver stress, resilience, engagement with resources, and participant feedback to inform future caregiver support interventions.

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia; Caregiver Burden; Caregiver Stress; Caregiver Burden of People With Dementia
• Intervention / Treatment: Behavioral: Care Partner Support and Education Messaging

Detailed Description

Care partners of people living with dementia often experience high levels of stress, burden, and unmet support needs, particularly during transitions of care. Even after participating in prior observational research, caregiving demands and stressors may evolve over time, highlighting the need for ongoing education and support.

This is a mixed-methods, minimal-risk interventional study designed to evaluate the feasibility and utility of a low-intensity, supportive education and resource intervention for care partners of people living with dementia. Participants eligible for this study are care partners who previously completed an approved observational study conducted in the emergency department setting.

The study consists of three sequential phases. In the first phase, participants complete a baseline telephone interview assessing caregiver stress, burden, resilience, technology literacy, and caregiving experiences. Participants also complete a brief, structured stress journaling activity over a two-week period to document daily caregiving-related stressors.

In the second phase, participants receive a six-week series of automated educational and supportive messages delivered by text message or email. These messages provide dementia caregiving education, stress and grief management strategies, and links to publicly available caregiver resources. Brief check-in surveys are used to assess participant engagement, perceived usefulness of the materials, and caregiving stressors during this period.

In the final phase, participants are invited to attend an optional, in-person peer support focus group facilitated by trained study personnel. The focus group provides an opportunity for participants to share experiences, discuss caregiving needs, and provide qualitative feedback on the intervention. Sessions are audio recorded for qualitative analysis.

The primary goals of this continuation supplement are to assess the feasibility of delivering supportive educational resources to care partners using low-touch methods, evaluate changes in caregiver stress and resilience, and gather qualitative feedback to inform future caregiver support interventions.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michelle Fischer, MD, MPH; Phone Number: 717-531-1443; Email: mfischer1@pennstatehealth.psu.edu
• Study Contact Backup: Name: Kalen Research Project Manager, MS; Email: kkearcher@pennstatehealth.psu.edu

Study Locations

• United States
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Milton S. Hershey Medical Center
      • Contact: Michelle Fischer, MD, MPH; Phone Number: 717-531-1443; Email: mfischer1@pennstatehealth.psu.edu
      • Contact: Email: kkearcher@pennstatehealth.psu.edu
      • Principal Investigator: Michelle Fischer, MD, MPH
      • Sub-Investigator: Rollin Wright, MD, MA, MPH, MS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Person completed the CarES Observational Study.
• Person is a care partner and:
• Lives with the person living with dementia or
• Checks on them at least once per week in person or by phone
• Person is willing and able to participate in study assessments

Exclusion Criteria:

• Person is no longer a care partner for a person living with dementia
• Person declines participation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Care Partner Support and Education Intervention (Continuation Supplement); Participants receive a low-intensity, supportive intervention that includes a baseline phone interview, a short period of daily stress journaling, and a six-week series of automated educational and supportive messages delivered by text message or email. Messages provide dementia caregiving education, stress management strategies, and links to publicly available resources. Participants complete brief surveys to assess engagement, stress, and resilience and may participate in an optional peer support focus group to provide qualitative feedback on the intervention.

Behavioral: Care Partner Support and Education Messaging; Care partners receive a low-intensity, supportive intervention consisting of automated educational and supportive messages delivered by text message (SMS) or email over a six-week period. Messages include brief dementia caregiving education, stress and grief management strategies, and links to publicly available caregiving and community support resources. Participants are asked to complete brief check-in surveys to assess engagement, perceived usefulness of the materials, and caregiving stressors.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Care Partner Stress	Caregiver stress will be assessed using the Stress Thermometer, scored from 0 (no stress/distress) to 4 (extreme stress/distress). Higher scores indicate greater stress (worse outcome).	Baseline (prior to intervention) to post-intervention (approximately 6 weeks).
Change In Care Partner Burden	Caregiver burden will be assessed using the 3-item Zarit Caregiver Burden Interview Screen, calculated as the sum of 3 items, each scored 0-4, for a total score range 0-12 (calculated from item scoring). Higher total scores indicate greater caregiver burden (worse outcome).	Baseline (prior to intervention) to post-intervention (approximately 6 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Care Partner Resilience (Brief Resilience Scale total score)	Care partner resilience will be assessed using the Brief Resilience Scale (BRS). The Brief Resilience Scale total score will be calculated as the mean of 6 items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree). Total scores range from 1 to 5, with higher scores indicating greater resilience (better outcome).	Baseline to post-intervention (approximately 6 weeks).

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Engagement With Support Resources (check-in survey completion rate)	Participant engagement will be assessed by the proportion of SMS/email check-in surveys completed during the intervention period. Engagement will be calculated as the number of completed check-in surveys divided by the number of surveys sent, expressed as a percentage (0-100%). Higher percentages indicate greater engagement with program communications and support resources.	During the 6-week intervention period
Perceived usefulness of support resources	Participant-reported usefulness of educational and supportive materials will be assessed using a self-reported usefulness rating collected through check-in surveys. Ratings will be reported on a Likert scale (e.g., 1-5), with higher scores indicating greater perceived usefulness of the materials.	During the 6-week intervention period
Feasibility of the Support Intervention	Feasibility assessed by participation rates, survey completion rates, and retention across intervention phases.	Up to 3 months
Qualitative Care Partner Experiences and Feedback	Qualitative themes related to caregiving experiences, perceived needs, and feedback on the intervention will be identified through semi-structured empathy-focused interviews and peer support focus groups conducted with care partners. Transcripts will be analyzed using qualitative thematic analysis to identify common experiences, perceived benefits, challenges, and suggestions for improving the intervention.	During the intervention period and within 2 weeks following completion of the 6-week intervention

Collaborators and Investigators

• Sponsor: Milton S. Hershey Medical Center
• Collaborators: NYU Langone Health; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Michelle Fischer, MD, MPH, Penn State College of Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: December 19, 2025
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurocognitive Disorders; Stress, Psychological; Behavior; Caregiver Burden; Dementia
• Other Study ID Numbers: STUDY00024235; 5R33AG069822-05 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No