Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:09 AM
Study NCT ID:
NCT07461168
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-10
First Post:
2025-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the Emergency Department
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-04', 'studyFirstSubmitDate': '2025-12-19', 'studyFirstSubmitQcDate': '2026-03-04', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Engagement With Support Resources (check-in survey completion rate)', 'timeFrame': 'During the 6-week intervention period', 'description': '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.'}, {'measure': 'Perceived usefulness of support resources', 'timeFrame': 'During the 6-week intervention period', 'description': '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.'}, {'measure': 'Feasibility of the Support Intervention', 'timeFrame': 'Up to 3 months', 'description': 'Feasibility assessed by participation rates, survey completion rates, and retention across intervention phases.'}, {'measure': 'Qualitative Care Partner Experiences and Feedback', 'timeFrame': 'During the intervention period and within 2 weeks following completion of the 6-week intervention', 'description': '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.'}], 'primaryOutcomes': [{'measure': 'Change in Care Partner Stress', 'timeFrame': 'Baseline (prior to intervention) to post-intervention (approximately 6 weeks).', 'description': '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).'}, {'measure': 'Change In Care Partner Burden', 'timeFrame': 'Baseline (prior to intervention) to post-intervention (approximately 6 weeks)', 'description': '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).'}], 'secondaryOutcomes': [{'measure': 'Care Partner Resilience (Brief Resilience Scale total score)', 'timeFrame': 'Baseline to post-intervention (approximately 6 weeks).', 'description': '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).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia', 'Caregiver Stress', 'Caregiver Burden', 'Caregiver Burden of People With Dementia']}, 'descriptionModule': {'briefSummary': '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.\n\nParticipants 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.', 'detailedDescription': '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.\n\nThis 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.\n\nThe 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.\n\nIn 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.\n\nIn 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Person completed the CarES Observational Study.\n* Person is a care partner and:\n* Lives with the person living with dementia or\n* Checks on them at least once per week in person or by phone\n* Person is willing and able to participate in study assessments\n\nExclusion Criteria:\n\n* Person is no longer a care partner for a person living with dementia\n* Person declines participation'}, 'identificationModule': {'nctId': 'NCT07461168', 'acronym': 'CarES', 'briefTitle': 'Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the Emergency Department', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Penn State Emergency Medicine CarES: Care-partner Evaluation and Sourcing in the ED', 'orgStudyIdInfo': {'id': 'STUDY00024235'}, 'secondaryIdInfos': [{'id': '5R33AG069822-05', 'link': 'https://reporter.nih.gov/quickSearch/5R33AG069822-05', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Care Partner Support and Education Intervention (Continuation Supplement)', 'description': '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.', 'interventionNames': ['Behavioral: Care Partner Support and Education Messaging']}], 'interventions': [{'name': 'Care Partner Support and Education Messaging', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Care Partner Support and Education Intervention (Continuation Supplement)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17033', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'contacts': [{'name': 'Michelle Fischer, MD, MPH', 'role': 'CONTACT', 'email': 'mfischer1@pennstatehealth.psu.edu', 'phone': '717-531-1443'}, {'role': 'CONTACT', 'email': 'kkearcher@pennstatehealth.psu.edu'}, {'name': 'Michelle Fischer, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rollin Wright, MD, MA, MPH, MS', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}], 'centralContacts': [{'name': 'Michelle Fischer, MD, MPH', 'role': 'CONTACT', 'email': 'mfischer1@pennstatehealth.psu.edu', 'phone': '717-531-1443'}, {'name': 'Kalen Research Project Manager, MS', 'role': 'CONTACT', 'email': 'kkearcher@pennstatehealth.psu.edu'}], 'overallOfficials': [{'name': 'Michelle Fischer, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'NYU Langone Health', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Emergency Medicine and Program Director, Emergency Medicine Residency', 'investigatorFullName': 'Michelle A. Fischer', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}