Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-27 @ 11:54 PM
Study NCT ID:
NCT02275234
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2014-10-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Care After Resuscitation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006323', 'term': 'Heart Arrest'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000083626', 'term': 'Psychosocial Intervention'}], 'ancestors': [{'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-08', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-08-31', 'studyFirstSubmitDate': '2014-10-17', 'studyFirstSubmitQcDate': '2014-10-23', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Quality of Life as measured by responses on SF36', 'timeFrame': '6 months', 'description': 'Change in Quality of Life before and after psychological intervention in patients surviving cardiac arrest and their family/friends'}, {'measure': 'Change in cognitive function as measured by responses on Montreal Cognitive function tool', 'timeFrame': '6 months', 'description': 'Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends'}, {'measure': 'Change in cognitive function as measured by responses on Cogfail questionnaire', 'timeFrame': '6 months', 'description': 'Change in cognitive function before and after psychological intervention in patients surviving cardiac arrest and their family/friends'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cardiac arrest', 'psychological intervention'], 'conditions': ['Cardiac Arrest']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether simple psychological interventions can be implemented at the Essex Cardiothoracic Centre (CTC) with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.', 'detailedDescription': 'At the Essex Cardiothoracic Centre (CTC) the follow up of patients surviving cardiac arrest demonstrated that standard psychological support arrangements for patients and their families/relatives were inadequate.\n\nThe purpose of this study is to investigate simple psychological interventions can be implemented here at the Essex CTC with a view to supporting the psychological wellbeing of survivors of cardiac arrest during their recovery.\n\nThe investigators propose to recruit 2 groups of patients. The first group will be chosen from patients who have already survived a cardiac arrest \\> 3 months prior to the start of the study. Participants in this group (patient and a relative/friend) will be invited to attend an outpatient clinic at the Essex CTC with members of the research team. The investigators will record general physical health condition and psychological wellbeing, using recommended questionnaires. A referral to onsite consultant psychiatrist will be offered to anyone expressing signs of severe depression.\n\nThe second group will be recruited from patients who survive cardiac arrest from the start of study date. Participants in this group (patient and a relative/friend) will be approached by a member of the research team whilst in hospital and an informed consent will be obtained. Baseline data will be acquired using the recommended questionnaires and a supportive psychological intervention will be offered in the form of a dedicated telephone helpline, attendance at a cardiac arrest clinic and early referral to clinical psychiatrist if appropriate for psychological help. At around 6 months from the date of cardiac arrest, participants will be invited to attend a clinic to reevaluate post cardiac arrest care using the same recommended questionnaires. At the end of the study, the data between the 2 groups will be analysed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retrospective and prospective cohort of patients following cardiac arrest', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Anyone surviving cardiac arrest\n* Age greater than or equal to 18 yrs\n* Cerebral Performance Category (CPC) 1-2 at the time of discharge from hospital\n* English speaking\n* Able to give informed consent\n\nExclusion Criteria:\n\n* Age less than 18yrs\n* CPC 3-5 at the time of discharge from hospital\n* Non-English speaking\n* Unable to give informed consent'}, 'identificationModule': {'nctId': 'NCT02275234', 'acronym': 'CARE', 'briefTitle': 'Care After Resuscitation', 'organization': {'class': 'OTHER', 'fullName': 'Mid and South Essex NHS Foundation Trust'}, 'officialTitle': 'A Feasibility Study of Implementing a Simple Psychological Intervention in Survivors of Cardiac Arrest and Their Family Members/Friend to Assess the Impact on Their Quality of Life and Cognitive Function', 'orgStudyIdInfo': {'id': 'B709'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retrospective', 'description': 'Patients who survived cardiac arrest \\>3 months prior to the start of the study and a close family/friend,will be invited to attend an outpatient clinic'}, {'label': 'Prospective- psychological intervention', 'description': 'In patients who survived cardiac arrest and a close family/friend,will be invited to attend an outpatient clinic', 'interventionNames': ['Other: Psychological intervention']}], 'interventions': [{'name': 'Psychological intervention', 'type': 'OTHER', 'description': 'Psychological support via clinic visit, helpline and telephone calls', 'armGroupLabels': ['Prospective- psychological intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SS16 5NL', 'city': 'Basildon', 'state': 'Essex', 'country': 'United Kingdom', 'facility': 'The Essex Cardiothoracic Centre', 'geoPoint': {'lat': 51.56844, 'lon': 0.45782}}], 'overallOfficials': [{'name': 'Thomas R Keeble, MBBS MD MRCP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Basildon and Thurrock University Hospitals NHS FT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mid and South Essex NHS Foundation Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Anglia Ruskin University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}