Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-30 @ 11:34 PM
Study NCT ID:
NCT00858533
Status:
COMPLETED
Last Update Posted:
2024-10-30
First Post:
2009-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Health At Work Workplace Health Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-01', 'completionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2009-03-09', 'studyFirstSubmitQcDate': '2009-03-09', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of days off work through sickness absence after index consultation, which will also apply to people at work with a work-relevant condition', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Secondary outcome measure: time to first return to work (RTW) allowing for phased return.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['early intervention', 'sickness absence', 'return to work', 'primary care'], 'conditions': ['Workplace Health']}, 'descriptionModule': {'briefSummary': 'This pilot study will compare workplace health intervention delivered by advisors based in GP practices with normal GP care to assess the usefulness of the concept and its potential for wider use in a larger randomised controlled trial.', 'detailedDescription': 'The aim of this pilot study is to examine the impact of H@W intervention(s) on job retention and return to work and compare outcomes with those from normal GP care. The target population for this study is people still at work but experiencing a work-related health problem as well as those off work. For the purpose of the study, short term sickness absence is defined as a period of 4 weeks or less and long term sickness absence defined as a period of 4 weeks or longer. Hypothesis\n\nThat H@W intervention in comparison to standard care:\n\n* promotes work retention\n* enables a quick and sustained return to work for those on short term sick leave (4 weeks or less)\n* achieves sustained return to work for those on long term sick leave of 4 weeks or more. This could include a phased return to work.\n* achieves positive outcomes which could mean leaving one job and starting another.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* People with work related health problems registered with GP practices in Liverpool Primary Care Trust.\n\nExclusion Criteria:\n\n* People registered with GP practices outside Liverpool Primary Care Trust.\n* Vulnerable adults and those considered by their GP to be unsuitable for the trial.'}, 'identificationModule': {'nctId': 'NCT00858533', 'acronym': 'H@W', 'briefTitle': 'Trial of Health At Work Workplace Health Intervention', 'organization': {'class': 'OTHER', 'fullName': 'University of Liverpool'}, 'officialTitle': 'A Pilot Controlled Feasibility Trial of Early Health At Work Workplace Intervention', 'orgStudyIdInfo': {'id': 'BER10457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'workplace health advice', 'description': 'The intervention group will receive additional support from a H@W Workplace Health Advisor who will deliver an intervention aimed at sickness absence prevention or sustained return to work, depending on individual circumstances.', 'interventionNames': ['Behavioral: Health at Work workplace health advice and support']}, {'type': 'NO_INTERVENTION', 'label': 'GP sickness absence consultation', 'description': 'Routine general practitioner care for workplace sickness absence.'}], 'interventions': [{'name': 'Health at Work workplace health advice and support', 'type': 'BEHAVIORAL', 'description': 'The intervention group will receive additional support from a H@W Workplace Health Advisor who will deliver an intervention aimed at sickness absence prevention or sustained return to work, depending on individual circumstances. The intervention will be standardized as far as possible to show types of activity undertaken with participants, their GP, line managers, human resources departments and trade union representatives.', 'armGroupLabels': ['workplace health advice']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L69 3GB', 'city': 'Liverpool', 'state': 'Merseyside', 'country': 'United Kingdom', 'facility': 'Division of Primary Care, University of Liverpool.', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}], 'overallOfficials': [{'name': 'Mark B Gabbay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Liverpool'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Liverpool', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}