Trial of Health at Work Workplace Health Intervention (H@W)
| Tracking Information | |||||
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| First Received Date ICMJE | March 9, 2009 | ||||
| Last Updated Date | July 26, 2010 | ||||
| Start Date ICMJE | June 2008 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Number of days off work through sickness absence after index consultation, which will also apply to people at work with a work-relevant condition [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00858533 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Secondary outcome measure: time to first return to work (RTW) allowing for phased return. [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Trial of Health at Work Workplace Health Intervention | ||||
| Official Title ICMJE | A Pilot Controlled Feasibility Trial of Early Health at Work Workplace Intervention | ||||
| Brief Summary | 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. |
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| Detailed Description | 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 That H@W intervention in comparison to standard care:
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
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| Condition ICMJE | Workplace Health | ||||
| Intervention ICMJE | Behavioral: Health at Work workplace health advice and support
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. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 63 | ||||
| Completion Date | March 2010 | ||||
| Primary Completion Date | March 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00858533 | ||||
| Other Study ID Numbers ICMJE | BER10457 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Professor Mark Gabbay, University of Liverpool | ||||
| Study Sponsor ICMJE | University of Liverpool | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Liverpool | ||||
| Verification Date | January 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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