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

NCT07461168 | Not Yet Recruiting

• 2 other identifiers: STUDY000242355R33AG069822-05
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dementia; Caregiver Stress; Caregiver Burden; Caregiver Burden of People With Dementia

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Care Partner Resilience (Brief Resilience Scale total score)

  Baseline to post-intervention (approximately 6 weeks).

Other Outcomes (4)

• Engagement With Support Resources (check-in survey completion rate)

  During the 6-week intervention period

• Perceived usefulness of support resources

  During the 6-week intervention period

• Feasibility of the Support Intervention

  Up to 3 months

Study Arms (1)

Care Partner Support and Education Intervention (Continuation Supplement)

EXPERIMENTAL

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

Interventions

Care Partner Support and Education Messaging BEHAVIORAL

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.

Care Partner Support and Education Intervention (Continuation Supplement)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• NYU Langone Health: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Study Officials

• Michelle Fischer, MD, MPH

  Penn State College of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michelle Fischer, MD, MPH

CONTACT

717-531-1443; mfischer1@pennstatehealth.psu.edu

Kalen Research Project Manager, MS

CONTACT

kkearcher@pennstatehealth.psu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Emergency Medicine and Program Director, Emergency Medicine Residency

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: March 10, 2026
• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: April 15, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)