EmploymentPATHWAYSNCT03519334
PATHWAYS in Europe
An observational study of Employment, run by Maria Cabello at 10 sites in 9 countries.
Trial summary
PATHWAYS is a 3-year project that directly contributes to the 2014 Work Programme by focusing on action 2.1.1.3 regarding the development of innovative approaches to promote the professional integration and reintegration of people with chronic diseases and improve their employability. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Employment
- How many people
- 686 participants
- Where
- 10 sitesin 9 countries
- Study dates
- May 2015to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
- 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
Who cannot join
- Younger than 18 years
- No residents in European Union (EU-28)
- Expert consultation study:
- Advocacy organizations not operating at European Union Level
Trial locations and contacts
10 sites in 9 countries.
10 sites in 9 countries
Spain2 sites
Universidad Autonoma de Madrid
Madrid, 28029
Fundació Sant Joan de Déu
Sant Boi de Llobregat, Barcelona
Slovenia1 site
University Rehabilitation Institute, Republic of Slovenia
Ljubljana
About this study
Official title: PArticipation To Healthy Workplaces And Inclusive Strategies in the Work Sector
PATHWAYS is a 3-year project that directly contributes to the 2014 Work Programme by focusing on action 2.1.1.3 regarding the development of innovative approaches to promote the professional integration and reintegration of people with chronic diseases and improve their employability. The main aim of PATHWAYS is to provide evidence-based recommendations for the effective professional integration of people with chronic health conditions in Europe
Read the 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
- Conditions
- Employment
- Keywords
- Employment, Return to work, Career Mobility, Employment supported, Workplace, Chronic disease
- Medical subject headings
- Chronic Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 | |
| Expert consultation group/study | Relevant contacts from advocacy organizations operating at European level for the professional integration of people with chronic health conditions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Employment needs
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)
Measured: One time point assessment. Period of data collection: An average of 3 years (2016-2018)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study startMay 2015
- Primary completionJun 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EmploymentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 686 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maria Cabello
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Ludwig-Maximilians - University of Munich, Fundació Sant Joan de Déu, University Rehabilitation Institute, Republic of Slovenia, University of Thessaly, KABEG Management, Jagiellonian University, Charles University, Czech Republic, Oslo Metropolitan University, European Association of Service providers for Persons with Disabilities
- Responsible party
- Sponsor-investigator, Maria Cabello, Universidad Autonoma de Madrid
- Investigators
- Jose Luis Mateos, MD, PhD, Principal investigator, Universidad Autonoma de Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03519334
- Sponsor's protocol ID
- PATHWAYS2020
- Other IDs
- HP-PJ-2014-663474
- Acronym
- PATHWAYS
- Status last verified
- Nov 2017
- First submitted
- 8 Nov 2017
- Last updated
- 8 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: A sharing plan description has to be still agreed between different Principal Investigators
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PArticipation To Healthy Workplaces And Inclusive Strategies in the Work Sector
- ClinicalTrials.gov ID
- NCT03519334
- Acronym / sponsor ID
- PATHWAYS / PATHWAYS2020
- Conditions
- Employment
- Keywords
- Employment, Return to work, Career Mobility, Employment supported, Workplace, Chronic disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 686 participants (actual)
- Lead sponsor
- Maria CabelloUniversity, hospital or other
- Collaborators
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta, Ludwig-Maximilians - University of Munich, Fundació Sant Joan de Déu, University Rehabilitation Institute, Republic of Slovenia, University of Thessaly, KABEG Management, Jagiellonian University, Charles University, Czech Republic, Oslo Metropolitan University, European Association of Service providers for Persons with Disabilities
- Study start
- May 2015 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PATHWAYS is a 3-year project that directly contributes to the 2014 Work Programme by focusing on action 2.1.1.3 regarding the development of innovative approaches to promote the professional integration and reintegration of people with chronic diseases and improve their employability. The main aim of PATHWAYS is to provide evidence-based recommendations for the effective professional integration of people with chronic health conditions in Europe
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
| Expert consultation group/study | – | –Relevant contacts from advocacy organizations operating at European level for the professional integration of people with chronic health conditions. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
- 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
Key exclusion criteria (4 listed)
- Younger than 18 years
- No residents in European Union (EU-28)
- Advocacy organizations not operating at European Union Level
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Employment needs
Time frame: One time point assessment. Period of data collection: An average of 3 years (2016-2018)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2018.
- PATHWAYS websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. A sharing plan description has to be still agreed between different Principal Investigators
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Luis Mateos, MD, PhD principal investigator
Universidad Autonoma de Madrid
10 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Employment, run by Maria Cabello at 10 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain, Austria, Czechia, Germany, Greece and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Employment needs (time frame: One time point assessment. Period of data collection: An average of 3 years (2016-2018)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2018.