Ignite Creation Date:
2025-12-24 @ 5:54 PM
Ignite Modification Date:
2025-12-29 @ 1:34 AM
Study NCT ID:
NCT06048068
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2023-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events
Sponsor:
Organization:
Raw JSON
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All articles are available in both English and Spanish.', 'otherNumAtRisk': 36, 'deathsNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'deathsNumAffected': 11, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Participants in this arm will receive usual care and no access to the informational intervention program.', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 5, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mishel Uncertainty in Illness Scale Score - Family Member Form', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Informational Intervention Arm', 'description': 'Participants in this arm will receive access to the informational intervention program, via a website link that they will access through their own person phone/tablet/computer.\n\nEducational Informational Platform: This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Participants in this arm will receive usual care and no access to the informational intervention program.'}], 'classes': [{'categories': [{'measurements': [{'value': '82.67', 'groupId': 'OG000', 'lowerLimit': '78.31', 'upperLimit': '87.02'}, {'value': '88.18', 'groupId': 'OG001', 'lowerLimit': '83.04', 'upperLimit': '93.32'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported', 'description': "This metric is a 31-item scale measuring surrogates' self-reported uncertainty related to their loved one's cardiac arrest. Participants will be asked to answer from a scale of 1 to 5, 1 being 'Strongly Disagree' and 5 being 'Strongly Agree.' The scale will be scored out of 155. 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All articles are available in both English and Spanish.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Participants in this arm will receive usual care and no access to the informational intervention program.'}], 'classes': [{'categories': [{'measurements': [{'value': '22.1', 'spread': '13.3', 'groupId': 'OG000'}, {'value': '32.7', 'spread': '12.65', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported', 'description': "This metric is a 20-item measure of self-reported post-traumatic stress symptoms as defined by the DSM-5. Participants will be asked to score their answer from 0 to 4, 0 being 'Not at all,' and 4 being 'Extremely.' The total score will be out of 80. A higher score indicates more severe PTSD symptoms.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Cardiac Anxiety Questionnaire Score - Fear Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Control Arm', 'description': 'Participants in this arm will receive usual care and no access to the informational intervention program.'}, {'id': 'OG001', 'title': 'Informational Intervention Arm', 'description': 'Participants in this arm will receive access to the informational intervention program, via a website link that they will access through their own person phone/tablet/computer.\n\nEducational Informational Platform: This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish.'}], 'classes': [{'categories': [{'measurements': [{'value': '18.3', 'spread': '3.8', 'groupId': 'OG000'}, {'value': '18.9', 'spread': '7.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Data was collected at hospital discharge (approximately 21 days after baseline) and 3 months post-hospital discharge. The data at 3 months post-discharge is reported', 'description': "This 8-item metric measures surrogates' self-reported fear of their loved one's cardiac-related stimuli and sensations due to perceived negative consequences. Participants will be asked to rank answers from 1 to 5, 1 being 'Never' and 5 being 'Always.' The total will be out of 40. A higher score indicates more fear and worry related to the heart.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Zarit Burden Interview 12-item Short Form Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Informational Intervention Arm', 'description': 'Participants in this arm will receive access to the informational intervention program, via a website link that they will access through their own person phone/tablet/computer.\n\nEducational Informational Platform: This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'Participants in this arm will receive usual care and no access to the informational intervention program.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'spread': '6.75', 'groupId': 'OG000'}, {'value': '18.6', 'spread': '8.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 3 months post-discharge.', 'description': 'This 12-item metric measures surrogates\' self-reported caregiver burden. Participants will be asked to score their answers from 0 to 4, 0 being "Never," and 4 being "Always." The total score is taken out of 48. A higher total score indicates a greater degree of caregiver burden.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Informational Intervention Arm', 'description': 'Participants in this arm will receive access to the informational intervention program, via a website link that they will access through their own person phone/tablet/computer.\n\nEducational Informational Platform: This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish.'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'Participants in this arm will receive usual care and no access to the informational intervention program.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Informational Intervention Arm', 'description': 'Participants in this arm will receive access to the informational intervention program, via a website link that they will access through their own person phone/tablet/computer.\n\nEducational Informational Platform: This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish.'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'Participants in this arm will receive usual care and no access to the informational intervention program.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '48.2', 'spread': '16.0', 'groupId': 'BG000'}, {'value': '48.0', 'spread': '12.6', 'groupId': 'BG001'}, {'value': '48.2', 'spread': '14.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '38', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2025-10-07', 'size': 585915, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-10-07T19:13', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized 2:1 to the informational intervention group or the control group (care as usual). Participants will remain in their assigned arm for the entirety of their study participation. Randomization will be performed using the REDCap randomization module by a study coordinator. This study will be unblinded.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 53}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2023-09-15', 'resultsFirstSubmitDate': '2025-10-09', 'studyFirstSubmitQcDate': '2023-09-15', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-04', 'studyFirstPostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mishel Uncertainty in Illness Scale Score - Family Member Form', 'timeFrame': 'Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported', 'description': "This metric is a 31-item scale measuring surrogates' self-reported uncertainty related to their loved one's cardiac arrest. Participants will be asked to answer from a scale of 1 to 5, 1 being 'Strongly Disagree' and 5 being 'Strongly Agree.' The scale will be scored out of 155. A higher score indicates a greater level of uncertainty."}], 'secondaryOutcomes': [{'measure': 'Post-Traumatic Stress Disorder Checklist (PCL-5) Score', 'timeFrame': 'Data was collected at study enrollment in the ICU (baseline), at hospital discharge (approximately 21 days after baseline), and 3 months post-hospital discharge. The data at 3 months post-discharge is reported', 'description': "This metric is a 20-item measure of self-reported post-traumatic stress symptoms as defined by the DSM-5. Participants will be asked to score their answer from 0 to 4, 0 being 'Not at all,' and 4 being 'Extremely.' The total score will be out of 80. A higher score indicates more severe PTSD symptoms."}, {'measure': 'Cardiac Anxiety Questionnaire Score - Fear Subscale', 'timeFrame': 'Data was collected at hospital discharge (approximately 21 days after baseline) and 3 months post-hospital discharge. The data at 3 months post-discharge is reported', 'description': "This 8-item metric measures surrogates' self-reported fear of their loved one's cardiac-related stimuli and sensations due to perceived negative consequences. Participants will be asked to rank answers from 1 to 5, 1 being 'Never' and 5 being 'Always.' The total will be out of 40. A higher score indicates more fear and worry related to the heart."}, {'measure': 'Zarit Burden Interview 12-item Short Form Score', 'timeFrame': 'At 3 months post-discharge.', 'description': 'This 12-item metric measures surrogates\' self-reported caregiver burden. Participants will be asked to score their answers from 0 to 4, 0 being "Never," and 4 being "Always." The total score is taken out of 48. A higher total score indicates a greater degree of caregiver burden.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac arrest', 'uncertainty', 'cardiac anxiety', 'acute stress disorder', 'posttraumatic stress disorder', 'sleep', 'caregiver', 'family', 'surrogate', 'information', 'self care'], 'conditions': ['Cardiac Arrest']}, 'referencesModule': {'references': [{'pmid': '32078390', 'type': 'BACKGROUND', 'citation': 'Sawyer KN, Camp-Rogers TR, Kotini-Shah P, Del Rios M, Gossip MR, Moitra VK, Haywood KL, Dougherty CM, Lubitz SA, Rabinstein AA, Rittenberger JC, Callaway CW, Abella BS, Geocadin RG, Kurz MC; American Heart Association Emergency Cardiovascular Care Committee; Council on Cardiovascular and Stroke Nursing; Council on Genomic and Precision Medicine; Council on Quality of Care and Outcomes Research; and Stroke Council. Sudden Cardiac Arrest Survivorship: A Scientific Statement From the American Heart Association. Circulation. 2020 Mar 24;141(12):e654-e685. doi: 10.1161/CIR.0000000000000747. Epub 2020 Feb 12.'}, {'pmid': '11426476', 'type': 'BACKGROUND', 'citation': 'Parnia S, Waller DG, Yeates R, Fenwick P. A qualitative and quantitative study of the incidence, features and aetiology of near death experiences in cardiac arrest survivors. Resuscitation. 2001 Feb;48(2):149-56. doi: 10.1016/s0300-9572(00)00328-2.'}, {'pmid': '11755611', 'type': 'BACKGROUND', 'citation': 'van Lommel P, van Wees R, Meyers V, Elfferich I. Near-death experience in survivors of cardiac arrest: a prospective study in the Netherlands. Lancet. 2001 Dec 15;358(9298):2039-45. doi: 10.1016/S0140-6736(01)07100-8.'}, {'pmid': '15665319', 'type': 'BACKGROUND', 'citation': 'Azoulay E, Pochard F, Kentish-Barnes N, Chevret S, Aboab J, Adrie C, Annane D, Bleichner G, Bollaert PE, Darmon M, Fassier T, Galliot R, Garrouste-Orgeas M, Goulenok C, Goldgran-Toledano D, Hayon J, Jourdain M, Kaidomar M, Laplace C, Larche J, Liotier J, Papazian L, Poisson C, Reignier J, Saidi F, Schlemmer B; FAMIREA Study Group. Risk of post-traumatic stress symptoms in family members of intensive care unit patients. Am J Respir Crit Care Med. 2005 May 1;171(9):987-94. doi: 10.1164/rccm.200409-1295OC. Epub 2005 Jan 21.'}, {'pmid': '20071240', 'type': 'BACKGROUND', 'citation': "Ann-Britt T, Ella D, Johan H, Asa AB. Spouses' experiences of a cardiac arrest at home: an interview study. Eur J Cardiovasc Nurs. 2010 Sep;9(3):161-7. doi: 10.1016/j.ejcnurse.2009.12.005. Epub 2010 Jan 13."}, {'pmid': '34223386', 'type': 'BACKGROUND', 'citation': 'Grunau B, Dainty K, MacRedmond R, McDonald K, Sasaki A, Sarti AJ, Shemie SD, Cheung A, Gill J. A qualitative exploratory case series of patient and family experiences with ECPR for out-of-hospital cardiac arrest. Resusc Plus. 2021 Apr 28;6:100129. doi: 10.1016/j.resplu.2021.100129. eCollection 2021 Jun.'}, {'pmid': '27253993', 'type': 'BACKGROUND', 'citation': 'De Stefano C, Normand D, Jabre P, Azoulay E, Kentish-Barnes N, Lapostolle F, Baubet T, Reuter PG, Javaud N, Borron SW, Vicaut E, Adnet F. Family Presence during Resuscitation: A Qualitative Analysis from a National Multicenter Randomized Clinical Trial. PLoS One. 2016 Jun 2;11(6):e0156100. doi: 10.1371/journal.pone.0156100. eCollection 2016.'}, {'pmid': '22080636', 'type': 'BACKGROUND', 'citation': 'Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.'}, {'pmid': '28068794', 'type': 'BACKGROUND', 'citation': 'van Wijnen HG, Rasquin SM, van Heugten CM, Verbunt JA, Moulaert VR. The impact of cardiac arrest on the long-term wellbeing and caregiver burden of family caregivers: a prospective cohort study. Clin Rehabil. 2017 Sep;31(9):1267-1275. doi: 10.1177/0269215516686155. Epub 2017 Jan 9.'}, {'pmid': '19282084', 'type': 'BACKGROUND', 'citation': 'Wachelder EM, Moulaert VR, van Heugten C, Verbunt JA, Bekkers SC, Wade DT. Life after survival: long-term daily functioning and quality of life after an out-of-hospital cardiac arrest. Resuscitation. 2009 May;80(5):517-22. doi: 10.1016/j.resuscitation.2009.01.020. Epub 2009 Mar 17.'}, {'pmid': '34592400', 'type': 'BACKGROUND', 'citation': 'Douma MJ, Graham TAD, Ali S, Dainty KN, Bone A, Smith KE, Dennet L, Brindley PG, Kroll T, Frazer K. What are the care needs of families experiencing cardiac arrest?: A survivor and family led scoping review. Resuscitation. 2021 Nov;168:119-141. doi: 10.1016/j.resuscitation.2021.09.019. Epub 2021 Sep 27.'}, {'pmid': '36909925', 'type': 'BACKGROUND', 'citation': "Rojas DA, DeForge CE, Abukhadra SL, Farrell L, George M, Agarwal S. Family experiences and health outcomes following a loved ones' hospital discharge or death after cardiac arrest: A scoping review. Resusc Plus. 2023 Mar 3;14:100370. doi: 10.1016/j.resplu.2023.100370. eCollection 2023 Jun."}, {'pmid': '19805803', 'type': 'BACKGROUND', 'citation': "Bremer A, Dahlberg K, Sandman L. Experiencing out-of-hospital cardiac arrest: significant others' lifeworld perspective. Qual Health Res. 2009 Oct;19(10):1407-20. doi: 10.1177/1049732309348369."}, {'pmid': '34406981', 'type': 'BACKGROUND', 'citation': 'Armand S, Wagner MK, Ozenne B, Verbunt J, Sep SJS, Berg SK, Knudsen GM, Stenbaek DS. Acute Traumatic Stress Screening Can Identify Patients and Their Partners at Risk for Posttraumatic Stress Disorder Symptoms After a Cardiac Arrest: A Multicenter Prospective Cohort Study. J Cardiovasc Nurs. 2021 Aug 16. doi: 10.1097/JCN.0000000000000829. Online ahead of print.'}, {'pmid': '34242735', 'type': 'BACKGROUND', 'citation': 'Case R, Stub D, Mazzagatti E, Pryor H, Mion M, Ball J, Cartledge S, Keeble TR, Bray JE, Smith K. The second year of a second chance: Long-term psychosocial outcomes of cardiac arrest survivors and their family. Resuscitation. 2021 Oct;167:274-281. doi: 10.1016/j.resuscitation.2021.06.018. Epub 2021 Jul 6.'}, {'pmid': '35265851', 'type': 'BACKGROUND', 'citation': 'Muehlschlegel S, Perman SM, Elmer J, Haggins A, Teixeira Bailey ND, Huang J, Jansky L, Kirchner J, Kasperek-Wynn R, Lipman PD, Yeatts SD, Fetters MD, Dickert NW, Silbergleit R. The Experiences and Needs of Families of Comatose Patients After Cardiac Arrest and Severe Neurotrauma: The Perspectives of National Key Stakeholders During a National Institutes of Health-Funded Workshop. Crit Care Explor. 2022 Mar 4;4(3):e0648. doi: 10.1097/CCE.0000000000000648. eCollection 2022 Mar.'}, {'type': 'BACKGROUND', 'citation': 'Agarwal S CJ, Newman M, Abukhadra SL, Rojas D, DeForge C, Tincher I, Wylie J, Anderson ML, Marchionda C. . Prioritizing Interventions to Reduce anxiety and posttraumatic stress Among Racially and Ethnically Diverse family surrogates of Cardiac Arrest Survivors in the United States: A Cross-sectional Survey Study. (Under Review). 2022.'}, {'pmid': '31781003', 'type': 'BACKGROUND', 'citation': 'Anderson EC, Carleton RN, Diefenbach M, Han PKJ. The Relationship Between Uncertainty and Affect. 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J Eval Clin Pract. 2004 May;10(2):307-12. doi: 10.1111/j..2002.384.doc.x.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this study is to test the feasibility and acceptability of an informational website to reduce uncertainty, psychological distress, and caregiver burden among close family members of cardiac arrest patients. The investigators hypothesize that participants who receive access to the website will have lower rates of uncertainty, psychological distress, and caregiver burden at 3 months post-hospital discharge compared to participants who receive usual care.', 'detailedDescription': 'This study will be an unblinded, two-arm randomized controlled trial that enrolls up to 100 adult surrogates of living cardiac arrest patients hospitalized in the New York Presbyterian hospital system. Participants must be English- or Spanish-speaking and have a device with internet access. Participants will be randomized 2:1 to receive the informational intervention program or usual care (control).\n\nIntervention arm participants will receive the informational intervention in three discrete packages upon study enrollment, movement to the general medical floor, and at one month post-discharge. All participants will be assessed at study enrollment, hospital discharge, and 3 months post-discharge for their illness uncertainty, psychological distress, and caregiver burden. All participants will also wear a GENEActiv sleep monitor to track their sleep for one week following hospital discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Surrogate of a living NewYork Presbyterian Hospital cardiac arrest patient\n* English- or Spanish-speaking\n* Has a working smartphone, tablet, laptop, or other device with internet access\n\nExclusion Criteria:\n\n* Any medical and/or psychiatric impairment precluding them from complying with the protocol\n* Non-English and non-Spanish speaking\n* Lack of internet/device access\n* Surrogate of an adult CA patient who passed away\n* Cannot be reached for initial contact (3 unsuccessful attempts made in ICU)\n* Moved to the in-patient floor before initial contact can be established'}, 'identificationModule': {'nctId': 'NCT06048068', 'acronym': 'RESURFACE', 'briefTitle': "Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events", 'organization': {'class': 'OTHER', 'fullName': 'Columbia University'}, 'officialTitle': "Removing Surrogates' Uncertainty to Reduce Fear and Anxiety After Cardiac Events (RESURFACE): A Randomized Pilot Intervention Study", 'orgStudyIdInfo': {'id': 'AAAR8497'}, 'secondaryIdInfos': [{'id': 'P30AG064198', 'link': 'https://reporter.nih.gov/quickSearch/P30AG064198', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Informational Intervention Arm', 'description': 'Participants in this arm will receive access to the informational intervention program, via a website link that they will access through their own person phone/tablet/computer.', 'interventionNames': ['Behavioral: Educational Informational Platform']}, {'type': 'NO_INTERVENTION', 'label': 'Control Arm', 'description': 'Participants in this arm will receive usual care and no access to the informational intervention program.'}], 'interventions': [{'name': 'Educational Informational Platform', 'type': 'BEHAVIORAL', 'otherNames': ['Heartsight website, ourheartsight.com'], 'description': 'This intervention contains many informational articles for surrogates about cardiac arrest, the subsequent hospitalization, and the emotional journey following cardiac arrest. All articles are available in both English and Spanish.', 'armGroupLabels': ['Informational Intervention Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center/New York Presbyterian', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Sachin Agarwal, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Columbia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Columbia University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Neurology (Neurocritical Care)', 'investigatorFullName': 'Sachin Agarwal', 'investigatorAffiliation': 'Columbia University'}}}}