Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the Emergency Department
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorMilton S. Hershey Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Person completed the CarES Observational Study.
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
Disqualifiers
Person is no longer a care partner for a person living with dementia
Person declines participation
Trial design
Design model
Single group
Treatments tested in this trial
Care Partner Support and Education Messaging
BehavioralCare 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.
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Care Partner Support and Education Intervention (Continuation Supplement)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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).
Time frame
Baseline (prior to intervention) to post-intervention (approximately 6 weeks).2
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).
Time frame
Baseline (prior to intervention) to post-intervention (approximately 6 weeks)Secondary outcomes
1
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).
Time frame
Baseline to post-intervention (approximately 6 weeks).Other outcomes
1
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.
Time frame
During the 6-week intervention period2
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.
Time frame
During the 6-week intervention period3
Feasibility of the Support Intervention
Feasibility assessed by participation rates, survey completion rates, and retention across intervention phases.
Time frame
Up to 3 months4
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.
Time frame
During the intervention period and within 2 weeks following completion of the 6-week interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
NYU Langone Health
Collaborator
National Institute on Aging (NIA)
Collaborator
Source ClinicalTrials.gov
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