Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-28 @ 5:03 PM
Study NCT ID:
NCT04809961
Status:
WITHDRAWN
Last Update Posted:
2022-11-16
First Post:
2021-02-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Observation of NHS Staff Wellbeing Following Introduction of the I-care Peer Support App
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Recruitment', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-11-11', 'studyFirstSubmitDate': '2021-02-02', 'studyFirstSubmitQcDate': '2021-03-17', 'lastUpdatePostDateStruct': {'date': '2022-11-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Wellbeing', 'timeFrame': '12 months', 'description': 'Most frequent response (A/B/C).'}], 'secondaryOutcomes': [{'measure': 'Engagement', 'timeFrame': '12 months', 'description': 'Number of participants who have provided a rating'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['peer support', 'healthcare workforce', 'wellbeing', 'digital health', 'app'], 'conditions': ['Peer Group']}, 'descriptionModule': {'briefSummary': 'The coronavirus pandemic has had demonstrable impact upon healthcare workers. For healthcare workers this has meant disruption to vital access to peer support networks. In May 2020 the United Nations (UN) published a policy brief highlighting the importance of supporting mental health and wellbeing for communities affected by coronavirus. There is a need to find innovative solutions to facilitate support in the post-COVID-19 era and some innovations are emerging to fill this void but an evidence, long-term, sustainable, solution is yet to be proposed. In response, a digital app has been co-developed by UK researchers and healthcare staff with the intent to facilitate a virtual peer support mechanism for National Health Service (NHS) staff.', 'detailedDescription': 'Rationale: The coronavirus pandemic has had demonstrable impact upon healthcare workers. For healthcare workers this has meant disruption to vital access to peer support networks. In May 2020 the United Nations (UN) published a policy brief highlighting the importance of supporting mental health and wellbeing for communities affected by coronavirus. There is a need to find innovative solutions to facilitate support in the post-COVID-19 era and some innovations are emerging to fill this void but an evidence, long-term, sustainable, solution is yet to be proposed. In response, a digital app has been co-developed by UK researchers and healthcare staff with the intent to facilitate a virtual peer support mechanism for National Health Service (NHS) staff.\n\nAim: The main aim of this research is to determine the acceptability and efficacy of the newly developed I-care app to facilitate peer-support for NHS staff wellbeing.\n\nMethods: A mixed methods study with concurrent process evaluation will be conducted to explore the acceptability and efficacy of an app-based peer support platform for use by anyone working within Solent NHS Trust with access to an android mobile phone device. Data will be generated from quantitative app usage, binary survey responses, and qualitative interviews.\n\nPopulations: All staff within Solent NHS Trust with an android mobile phone will be considered eligible to use the app.\n\nDuration: Data will be collected at one, three, six, and 12-months post app launch.\n\nExpected outcomes: As the innovation developed has spanned biomedical, behavioural and computing science a range of exploratory methods are proposed to establish the reach and uptake of the innovation, early indication of a potential causal model explaining how the innovation could lead to benefit, identification of key components of the innovation as identified by end users, and estimation of overall acceptability and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All staff within a single UK Health Trust with an android mobile phone will be considered eligible to use the app.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All staff within a single UK Health Trust with an android mobile phone will be considered eligible to use the app\n\nExclusion Criteria:\n\n* Not employed within the designated Trust\n* Under 18 years of age\n* Unable or unwilling to provide informed consent'}, 'identificationModule': {'nctId': 'NCT04809961', 'acronym': 'I-Care', 'briefTitle': 'Longitudinal Observation of NHS Staff Wellbeing Following Introduction of the I-care Peer Support App', 'organization': {'class': 'OTHER', 'fullName': 'University of Southampton'}, 'officialTitle': 'Longitudinal Observation of United Kingdom NHS Staff Wellbeing Following Introduction of the I-care Peer Support App', 'orgStudyIdInfo': {'id': '61764'}}, 'armsInterventionsModule': {'interventions': [{'name': 'I-care app', 'type': 'OTHER', 'description': 'A smart phone app to enable healthcare worker peer support for improved workplace wellbeing.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SO17 1BJ', 'city': 'Southampton', 'state': 'Hampshire', 'country': 'United Kingdom', 'facility': 'Lindsey Cherry', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}], 'overallOfficials': [{'name': 'Lindsey Cherry, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southampton & Solent NHS Trust'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southampton', 'class': 'OTHER'}, 'collaborators': [{'name': 'Solent NHS Trust', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}