DementiaCarESNCT07461168
Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the Emergency Department
A study testing Care Partner Support and Education Messaging in people with Dementia and Caregiver Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Dementia, Caregiver Stress, Caregiver Burden
- What is being tested?
- Care Partner Support and Education Messaging
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2026to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Person is no longer a care partner for a person living with dementia
- Person declines participation
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kalen Research Project Manager, MS contact
United States1 site
Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Michelle Fischer, MD, MPH, 717-531-1443, mfischer1@pennstatehealth.psu.edu
kkearcher@pennstatehealth.psu.edu
About this study
Official title: 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.
Read the 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.
- Being tested
- Care Partner Support and Education Messaging
- Medical subject headings
- Dementia, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Partner Support and Education MessagingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Care Partner Support and Education Messaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: Baseline to post-intervention (approximately 6 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start31 Aug 2026 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Michelle A. Fischer, Milton S. Hershey Medical Center
- Investigators
- Michelle Fischer, MD, MPH, Principal investigator, Penn State College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07461168
- Sponsor's protocol ID
- STUDY00024235
- Other IDs
- 5R33AG069822-05
- Acronym
- CarES
- Status last verified
- Aug 2026
- First submitted
- 19 Dec 2025
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the ED
- ClinicalTrials.gov ID
- NCT07461168
- Acronym / sponsor ID
- CarES / STUDY00024235
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- NYU Langone Health, National Institute on Aging (NIA)
- Study start
- 31 Aug 2026 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Care Partner Support and Education Intervention (Continuation Supplement) | Experimental | Behavioral: Care Partner Support and Education MessagingParticipants 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Person is no longer a care partner for a person living with dementia
- Person declines participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care Partner Support and Education MessagingCare 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. | Behavioural | Care Partner Support and Education Intervention (Continuation Supplement) |
Primary outcome
Change in Care Partner Stress
Time frame: Baseline (prior to intervention) to post-intervention (approximately 6 weeks).
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).
Change In Care Partner Burden
Time frame: Baseline (prior to intervention) to post-intervention (approximately 6 weeks)
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).
1 secondary outcome
Care Partner Resilience (Brief Resilience Scale total score)
Time frame: Baseline to post-intervention (approximately 6 weeks).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kalen Research Project Manager, MS contact
Michelle Fischer, MD, MPH principal investigator
Penn State College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Partner Support and Education Messaging in people with Dementia and Caregiver Stress, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michelle Fischer, MD, MPH (717-531-1443, mfischer1@pennstatehealth.psu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Care Partner Stress (time frame: Baseline (prior to intervention) to post-intervention (approximately 6 weeks).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.