Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2026-01-26 @ 8:17 PM
Study NCT ID:
NCT03017469
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2017-01-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Achieving Resilience in Acute Care Nurses (ARISE).
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-06-14', 'releaseDate': '2023-12-28'}, {'resetDate': '2024-11-06', 'releaseDate': '2024-09-06'}], 'estimatedResultsFirstSubmitDate': '2023-12-28'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D000068376', 'term': 'Compassion Fatigue'}, {'id': 'D000073397', 'term': 'Occupational Stress'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D005222', 'term': 'Mental Fatigue'}, {'id': 'D005221', 'term': 'Fatigue'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009784', 'term': 'Occupational Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2017-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2017-01-09', 'studyFirstSubmitQcDate': '2017-01-09', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Connor Davidson Resilience Scale (CD-RISC)', 'timeFrame': '1 month post intervention'}], 'secondaryOutcomes': [{'measure': 'Connor Davidson Resilience Scale (CD-RISC)', 'timeFrame': '3 months post intervention'}, {'measure': 'Occupational fatigue and recovery (OFER) scale', 'timeFrame': '1 month post intervention', 'description': 'Acute fatigue and inter-shift recovery scales only'}, {'measure': 'Occupational fatigue and recovery (OFER) scale', 'timeFrame': '3 months post intervention', 'description': 'Acute fatigue and inter-shift recovery scales only'}, {'measure': 'Professional Quality of Life (ProQOL5) scale', 'timeFrame': '1 month post intervention'}, {'measure': 'Professional Quality of Life (ProQOL5) scale', 'timeFrame': '3 months post intervention'}, {'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': '1 month post intervention'}, {'measure': 'Perceived Stress Scale (PSS)', 'timeFrame': '3 months post intervention'}, {'measure': 'Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).', 'timeFrame': '1 month post intervention'}, {'measure': 'Occupational Coping Self-Efficacy Questionnaire for Nurses (OCSE-N).', 'timeFrame': '3 months post intervention'}, {'measure': 'Mindfulness Attention Awareness Scale (MASS)', 'timeFrame': '1 month post intervention'}, {'measure': 'Mindfulness Attention Awareness Scale (MASS)', 'timeFrame': '3 months post intervention', 'description': 'Mindfulness attention awareness will be measured using the Mindfulness Attention Awareness Scale (MASS).'}, {'measure': 'Program Evaluation Outcomes for ARISE participants', 'timeFrame': '1 month post intervention', 'description': 'For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.'}, {'measure': 'Program Evaluation Outcomes for ARISE participants', 'timeFrame': '3 months post intervention', 'description': 'For each component of the intervention, and for the ARISE program as a whole, we will ask participants to rate utility, satisfaction, and frequency of use of intervention components.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Resilience', 'Workplace Stress', 'Occupational Fatigue', 'Compassion Fatigue', 'Peer Support', 'Self-Care', 'Employee Assistance'], 'conditions': ['Stress, Psychological', 'Compassion Fatigue']}, 'referencesModule': {'references': [{'pmid': '11871630', 'type': 'BACKGROUND', 'citation': 'Aiken LH, Clarke SP, Sloane DM; International Hospital Outcomes Research Consortium. 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J Adv Nurs. 2006 Nov;56(4):438-49. doi: 10.1111/j.1365-2648.2006.04011.x.'}, {'pmid': '25095307', 'type': 'BACKGROUND', 'citation': 'Wittenberg-Lyles E, Goldsmith J, Reno J. Perceived benefits and challenges of an oncology nurse support group. Clin J Oncol Nurs. 2014 Aug;18(4):E71-6. doi: 10.1188/14.CJON.E71-E76.'}, {'pmid': '21708961', 'type': 'BACKGROUND', 'citation': 'Yates PJ, Benson EV, Harris A, Baron R. An investigation of factors supporting the psychological health of staff in a UK emergency department. Emerg Med J. 2012 Jul;29(7):533-5. doi: 10.1136/emj.2010.099630. Epub 2011 Jun 27.'}], 'seeAlsoLinks': [{'url': 'http://rnao.ca/bpg/guidelines/preventing-and-mitigating-nurse-fatigue-health-care', 'label': "Registered Nurses' Association of Ontario \\[RNAO\\]. (2011). Preventing and Mitigating Nurse Fatigue in Health Care Toronto, Canada Registered Nurses' Association of Ontario"}, {'url': 'http://www.compassionfatigue.org/pages/ProQOLManualOct05.pdf', 'label': 'Stamm, B. (2005 ). The ProQOL Manual: THE PROFESSIONAL QUALITY OF LIFE SCALE: Compassion Satisfaction, Burnout \\& Compassion Fatigue/Secondary Trauma Scales. Pocatello, ID.'}]}, 'descriptionModule': {'briefSummary': 'Nurses are exposed to myriad stressors, both in the workplace and in their everyday lives, which can lead to adverse personal and professional outcomes. While workplace stress cannot be eliminated, nurses can learn techniques to build resilience, mitigate stress, and decrease fatigue. Organizational employee health, wellness, and assistance programs are all intentioned to provide this type of support; however, nurses often lack awareness of options and opportunities, and access can be a challenge. The purpose of the proposed study is to assess the outcomes of a multi-modal intervention and toolkit, ARISE, designed to enhance resilience and promote awareness of organizational resources for health, wellness, and employee assistance. We will evaluate the impact of participation in ARISE on resilience and other outcomes in nurses in critical care and trauma settings. As a Best Practice Spotlight Organization designated by the Registered Nurses Association of Ontario (RNAO), this project will incorporate relevant recommendations from Best Practice Guidelines (BPG) related to Workplace Health, Safety, and Well-being of the Nurse; and Preventing and Mitigating Nurse Fatigue in Health Care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Nurse in the medical-surgical and trauma-neurosurgical intensive care units (MSICU and TNICU) and the medical/surgical floor (9CCN),\n* full-time or part-time employment status,\n* approval of clinical leader manager (CLM),\n* receipt of written informed consent.\n\nExclusion Crieria:\n\n* casual employment status\n* inability to attend intervention days'}, 'identificationModule': {'nctId': 'NCT03017469', 'briefTitle': 'Achieving Resilience in Acute Care Nurses (ARISE).', 'organization': {'class': 'OTHER', 'fullName': 'Unity Health Toronto'}, 'officialTitle': 'Achieving Resilience in Acute Care Nurses (ARISE): A Randomized Controlled Trial of a Multi-component Intervention for Nurses in Critical Care and Trauma.', 'orgStudyIdInfo': {'id': 'SMH30Dec2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ARISE Intervention', 'description': 'Nurses who participate in the 1.5 day ARISE Intervention', 'interventionNames': ['Other: ARISE']}, {'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': 'Nurses who do not participate in the ARISE Intervention'}], 'interventions': [{'name': 'ARISE', 'type': 'OTHER', 'description': '1. Full day (7.5 hours) workshop consisting of a resilience-focused seminar facilitated by our Employee Assistance Provider (EAP) \\[Shepell\\], an introduction to hospital based resources including EAP and health and wellness offerings, and an introduction to self-care and self-care techniques including yoga and stretches, stress relief using the senses and mindfulness\n2. Half day (3.75 hours) workshop focusing on the following self-care techniques: mindfulness, yoga and stretching, and creative and reflective reading and writing\n3. Peer support through social media engagement (closed Facebook group) for 3 months post-intervention participation\n4. Five online, instructor-guided mindfulness sessions (Zoom)', 'armGroupLabels': ['ARISE Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5B1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Unity Health Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Nursing/Clinical research, research manager, Critical Care Department, and associate scientist at the Li Ka Shing Knowledge Institute', 'investigatorFullName': 'Orla Smith', 'investigatorAffiliation': 'Unity Health Toronto'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-12-28', 'type': 'RELEASE'}, {'date': '2024-06-14', 'type': 'RESET'}, {'date': '2024-09-06', 'type': 'RELEASE'}, {'date': '2024-11-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Unity Health Toronto'}}}}