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Not yet recruiting NCT07461168

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

No phase Interventional Dementia Caregiver Stress Caregiver Burden Caregiver Burden of People With Dementia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Care Partner Support and Education Messaging.
Who it may be relevant to
Registry conditions: Dementia, Caregiver Stress, Caregiver Burden, Caregiver Burden of People With Dementia. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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 stressor

Primary outcome measures

  • Change in Care Partner Stress [Time frame: Baseline (prior to intervention) to post-intervention (approximately 6 weeks).]
  • Change In Care Partner Burden [Time frame: Baseline (prior to intervention) to post-intervention (approximately 6 weeks)]
Secondary outcome measures (1)
  • Care Partner Resilience (Brief Resilience Scale total score) [Time frame: Baseline to post-intervention (approximately 6 weeks).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Milton S. Hershey Medical Center — Hershey

Identifiers

NCT: NCT07461168 · STUDY00024235 · 5R33AG069822-05

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗