- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519334
PATHWAYS in Europe (PATHWAYS)
PArticipation To Healthy Workplaces And Inclusive Strategies in the Work Sector
Study Overview
Status
Conditions
Detailed Description
Introduction: One out four people experience any long-lasting health problem in Europe. Individuals with chronic diseases often experience work-related problems, leading to negative consequences at individual and societal level. The rising prevalence of chronic diseases as well as the current economic recession made this issue even more problematic, requiring action in terms of innovative strategies to improve the participation of these persons in the labor market.
The PATHWAYS objectives are:
- To identify integration and re-integration strategies that are available in Europe and beyond and to determine their effectiveness (systematic literature review)
- To assess the specific employment related needs of persons with chronic diseases and mental disorders (e-survey including people with chronic health conditions)
- To develop guidelines supporting the implementation of effective professional integration and reintegration strategies. (expert consultation survey)
Methods:
PATHWAYS is a multi-informant approach study. Information will be gathered from different sources:
- Systematic literature review,
- An expert consultation study (Including NGOs, patient's organizations and advocacy organizations operating at European Level). Experts will be searched by Internet. Questionnaire will be completed by e-mail
- an e-Survey including people with chronic health conditions. The Clinical Record Form (CRF) will be online (Google forms). Participation will be free. Any people who meet the inclusion criteria can log in and complete it. The dissemination of the CRF will be done via relevant patient's associations. The CRF will be also published in the patient association's websites, if possible
Hypothesis:
- Literature will focus on the negative points of experiencing chronic health problems in the workplace rather than analysing the professional needs of people with these health conditions
- There will be a set of professional needs that will be shared across different chronic health condition groups and that can be targeted in common preventive strategies
- There will be a considerable gap between the existing employment strategies (i.e. services, systems and policies) and the real employment needs of people with chronic health conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Hermagor, Austria
- KABEG Gailtal-Klinik
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Praha, Czechia
- Charles University Czech Republic
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Munich, Germany
- Ludwig Maximilian University
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Thessaloníki, Greece
- University of Thessaly
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Milan, Italy
- Foundation IRCCS Neurological Institute Carlo Besta
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Oslo, Norway
- Oslo and Akershus University College of Applied Sciences
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Kraków, Poland
- Jagiellonian University Medical College
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Ljubljana, Slovenia
- University Rehabilitation Institute, Republic of Slovenia
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Madrid, Spain, 28029
- Universidad Autonoma de Madrid
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Barcelona
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Sant Boi De Llobregat, Barcelona, Spain
- Fundació Sant Joan de Déu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Chronic health conditions will be defined by people with self reported diagnosis of any of the following health conditions: Diabetes, Chronic obstructive Pulmonary Disease, Major Depression, Dysthymia, Migraine, Back & Neck Pain, Cancer, Ischemic Heart Disease (According to International Classification of Diseases 10th version (ICD-10)
Experts will be people working in advocacy organizations. For example, NGOs and patient's associations. These associations shuld be aimed ar enhancing professional integration of people with chronic health conditions
Description
As PATHWAYS include different studies and methodologies, different inclusion and exclusion criteria are defined for each study
People with Chronic health condition study:
Inclusion Criteria:
- People with self-reported diagnosis of chronic health conditions (i.e Diabetes, Chronic obstructive Pulmonary Disease, Major Depression, Dysthymia, Migraine, Back & Neck Pain, Cancer, Ischemic Heart Disease)
- Participants living in European Union (EU-28)
- Working age: 18-65 years
Exclusion Criteria:
- Younger than 18 years
- No residents in European Union (EU-28)
Expert consultation study:
Inclusion Criteria:
- People working in Advocacy organizations. These organizations should meet all the following criteria: i) their main activities should be addressed at (re)integrating people with chronic health conditions into the workforce ii) they should operate at European level, and iii) they should have at least 3 years of experience in the field.
- Working age: 18-65 years
Exclusion Criteria:
- Advocacy organizations not operating at European Union Level
Study Plan
How is the study designed?
Design Details
- Observational Models: Other
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Chronic health condition group/study
People with any of the following chronic health conditions: Diabetes, Chronic obstructive Pulmonary Disease, Major Depression, Dysthymia, Migraine, Back & Neck Pain, Cancer, Ischemic Heart Disease
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Expert consultation group/study
Relevant contacts from advocacy organizations operating at European level for the professional integration of people with chronic health conditions.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Employment needs
Time Frame: One time point assessment. Period of data collection: An average of 3 years (2016-2018)
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Any environmental or personal factor that impact on the professional integration of people with chronic health conditions.
This definition has been conceptualized according to the International Classification of Disability and Health's framework (World Health Organization, 2001).
This outcome will be collected in the e-survey study (including people with chronic health conditions)
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One time point assessment. Period of data collection: An average of 3 years (2016-2018)
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jose Luis Mateos, MD, PhD, Universidad Autonoma de Madrid
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PATHWAYS2020
- HP-PJ-2014-663474 (Other Grant/Funding Number: European Commission)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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