Parkinson DiseaseEQuALNCT06573866
Enhancement of Quality of Work And Life
A study testing Preventive Participatory workplace intervention in people with Parkinson Disease and Hereditary Spastic Paraparesis, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Work participation is essential for quality of life, providing purpose, social interaction, financial security, and shaping social status. Work participation is increasingly compromised in people with slowly progressive chronic disorders (hereafter referred to as progressive disorders). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Parkinson Disease, Hereditary Spastic Paraparesis, Cerebellar Ataxia
- What is being tested?
- Preventive Participatory workplace intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteNetherlands
- Study dates
- 8 Oct 2024to 4 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- having a diagnosis Parkinson Disease, cerebellar ataxia, hereditairy spastic paraparesis, or a slowly progressive neuromuscular or mitochondrial disorder, confirmed by the treating physician (e.g. neurologist, rehabilitation physician)
- aged 18-65 years;
- being employed for at least 8 hours per week (at baseline). This also includes individuals who have reduced their working hours until reaching this threshold of 8 hours per week. Working time may be distributed across multiple working days;
- having the intention to continue to work during the study period of 18 months, to prevent inclusion of participants who plan to retire within the 18-month RCT period;
- being open to talk to the employer or manager about any changes or limitations in work performance (disclosing the diagnosis is not required, by law).
Who cannot join
- individuals who are at the beginning of a sick leave procedure (under the Gatekeeper Improvement Act; Wvp);
- being fully self-employed. Partial self-employment in addition to paid employment is allowed, on the condition that the paid employment accounts for more than half of the total weekly working hours;
- having a second employer for over eight hours per week;
- proficiency in the Dutch language is not sufficient;
- severe comorbidity or health-related event that will hamper compliance to the protocol, e.g. in case of a severe cognitive impairment, a relatively abrupt transition to a very progressive manifestation of the disease, a planned surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Enhancement of Quality of Work And Life: A Personalised Primary Preventive Work Intervention to Enhance Sustainable Work Participation in Persons With Neurodegenerative Movement Disorders
Work participation is essential for quality of life, providing purpose, social interaction, financial security, and shaping social status. Work participation is increasingly compromised in people with slowly progressive chronic disorders (hereafter referred to as progressive disorders). This negatively impacts their quality of life. Early work-related support, focused on sustainable work-retention, has the potential to enhance work participation in people with progressive disorders. Therefore, this study investigates the (cost)effectiveness of the Preventive Participatory Workplace Intervention (PPWI), a personalized work intervention to enhance sustainable work participation. The investigators perform an 18-month randomized controlled trial (RCT). In addition, the investigators perform a process evaluation and an economic evaluation alongside the RCT. 124 Dutch working persons with three types of movement disorders (Parkinson's Disease (PD), cerebellar ataxia (CA) and hereditary spastic paraparesis (HSP)) and with slowly progressive neuromuscular and mitochondrial disorders will be included.
Read the detailed description
Work participation is essential for quality of life, providing purpose, social interaction, financial security, and shaping social status and personal identity. Work participation is increasingly compromised in people with progressive disorders. This negatively impacts their quality of life. People with slowly progressive chronic disorders (hereafter referred to as progressive disorders) lack (structural) work-related support. Early work-related support, focused on sustainable work-retention, has the potential to enhance work participation in people with progressive disorders. Therefore, the EQuAL-study (Enhancement of Quality of work And Life) investigates the (cost)effectiveness of the Preventive Participatory Workplace Intervention (PPWI), a personalized intervention to enhance sustainable work participation in people with progressive disorders. The aim of the study is to investigate study effects of the PPWI on need for recovery after work (primary endpoint), perceived self-efficacy at work, work-related well-being, quality of life and absenteeism (secondary outcomes). In addition, the PPWI's cost-effectiveness and cost-utility and its the process of implementation and mechanisms of impact will be explored (second and third aim, respectively). To address these aims, the investigators perform an 18 month randomized controlled trial (RCT). A cost and process evaluation will be performed alongside the RCT. 124 Dutch working persons with types of movement disorders will be included: Parkinson's Disease (PD), cerebellar ataxia (CA), and hereditary spastic paraparesis (HSP) and with slowly progressive neuromuscular and mitochondrial disorders. Participants will be recruited from approximately twelve regions across the Netherlands. Participants will be randomised to either the PPWI or an usual care control group in a 1:1 ratio. The PPWI is a process intervention in which a trained process facilitator guides an employee and their manager in identifying work-related obstacles or changes and finding solutions to overcome or manage these obstacles. Its primary goal is to achieve consensus between employee and manager with respect to the most obstructive obstacles for functioning at work and feasible solutions. There are no restrictions on usual care. The study will evaluate between-group differences from baseline to 18-month follow-up in need for recovery after work (primary endpoint) and self-efficacy at work and indicators of quality of life, work-related well-being, and productivity (i.e. absenteeism and presenteeism). For the second aim, the investigators will measure the costs associated with healthcare use, productivity loss, work-related adjustments, and the intervention. For the third aim, the investigators will evaluate the process in terms of implementation of the PPWI, its mechanisms of impact and the implementation context. The investigators envision the PPWI to support sustainable work retention while preserving work-life balance and quality of life for individuals with progressive disorders. Additionally, the trial will provide insights into which intervention components are effective and why. This will help potential future PPWI users in making informed decisions about whether the costs are justified by the anticipated value and benefits.
- Conditions
- Parkinson Disease, Hereditary Spastic Paraparesis, Cerebellar Ataxia, Mitochondrial Diseases, Neuromuscular Diseases (NMD)
- Being tested
- Preventive Participatory workplace intervention
- Keywords
- Neurodegenerative disorders, Work, Quality of life, Work-life balance, Randomized controlled trial, Need for recovery, Sustainable work participation, Preventive work intervention
- Medical subject headings
- Parkinson Disease, Spastic Paraplegia, Hereditary, Cerebellar Ataxia, Mitochondrial Diseases, Neuromuscular Diseases, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventive Participatory workplace interventionBehavioural
The Participatory Workplace Intervention (PPWI) is a process intervention in which a trained process facilitator guides an employee and their manager in identifying work-related obstacles or changes and finding solutions to overcome or manage these obstacles. Its primary goal is to achieve consensus between employee and manager with respect to the most obstructive obstacles for functioning at work and feasible solutions. Following consensus, the stakeholders formulate and agree upon a plan of action and execute the plan. In a subsequent meeting, the implementation of the plan of action will be evaluated. Six months after the evaluation, a follow-up will take place to determine whether new obstacles have emerged and whether a new cycle of process steps should be initiated.
| Study group | Role | What they receive |
|---|---|---|
| Preventive Participatory workplace intervention (PPWI) | Experimental | Participants in the PPWI group will receive the PPWI and continue to receive usual care. Receives: Behavioral: Preventive Participatory workplace intervention |
| Usual care control group | No intervention | The usual care control group comprises usual care. There are no restrictions on usual care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for recovery after work
Need for recovery after work is measured using the subscale need for recovery after work of the Dutch language version of the Questionnaire on the Experience and Evaluation of Work questionnaire (VBBA 2.0).
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Secondary outcomes (10)
Perceived self-efficacy at work
Perceived self-efficacy at work is measured with the self-efficacy at work scale. It measures one's perceived self-efficacy in solving work- and disease-related problems and consists of 14 5-point Likert scale items. A higher score indicates a higher level of self-efficacy.
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Work home interference (WHI)
Work home interference (WHI) is measured with the subscale negative work-home interaction of the Survey Work-home Interaction - NijmeGen (SWING).
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Limitations in work
Limitations in work is measured with the Dutch language version of the Work Limitations Questionnaire (WLQ-mdlv).
Measured: Measured four timepoints: at baseline, and after 6, 12 and 18 months
Work-related stress
Work-related stress is measured with an 11-point single-item measure. The minimum value is 0 and maximum value is 10. A higher score indicates a higher level of experienced work-related stress.
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Job satisfaction
Job satisfaction is measured wit an 7-point Likert scale single-item measure. The minimum value is 1 and maximum value is 7. A higher score indicates a higher level of job satisfaction.
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Perceived balance in daily activities (i.e. life balance)
Percieved balance in daily activities as a parameter life balance, will be measured with the Dutch language version of the Occupational Balance Questionnaire (OBQ11-NL).
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Health-related Quality of Life (QoL)
Health-related QoL is measured with the EuroQuality of Life Five Dimension (EuroQol 5D (EQ-5D-5L)).
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Overall life satisfaction
Overall life satisfaction is measured with a single-item life satisfaction measure with an 11- point answer scale. The minimum value is 0 and maximum value is 10. A higher score indicates a higher level of life satisfaction.
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Absenteeism
Absenteeism data include dates of sick and recovery notifications, working hours of absence, and whether the sick notification was related to the movement disorder. At the baseline measurement, absenteeism data will be collected through a questionnaire applying a recall period of three months. Upon participation, we ask participants to keep track of their absenteeism on a scheme we provide them with.
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Presenteeism
Presenteeism refers to when employees show up to work despite being ill, that leads to reduced productivity. Presenteeism is measured with the presenteeism subscale of the iMTA Productivity Cost Questionnaire (iPCQ).
Measured: Measured four times: at baseline, and after 6, 12 and 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2024
- Study start8 Oct 2024
- Primary completion4 Mar 2027 (estimated)
- Study completion4 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned to either the PPWI (intervention) or the usual care (control) group, in a 1:1 ratio.
- Masking
- None (open label)
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), The Dutch Brain Foundation
- Responsible party
- Sponsor
- Investigators
- Elbrich Postma, PhD, Principal investigator, Radboud University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06573866
- Sponsor's protocol ID
- 115335
- Acronym
- EQuAL
- Status last verified
- Jun 2026
- First submitted
- 11 Jul 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Relevant and anonymised research data will be shared/published in the Radboud Data Repository (RDR) to guarantee long-term accessibility to the research data of the project of this research.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancement of Quality of Work And Life: A Personalised Primary Preventive Work Intervention to Enhance Sustainable Work Participation in Persons With Neurodegenerative Movement Disorders
- ClinicalTrials.gov ID
- NCT06573866
- Acronym / sponsor ID
- EQuAL / 115335
- Conditions
- Parkinson Disease, Hereditary Spastic Paraparesis, Cerebellar Ataxia, Mitochondrial Diseases, Neuromuscular Diseases (NMD)
- Keywords
- Neurodegenerative disorders, Work, Quality of life, Work-life balance, Randomized controlled trial, Need for recovery, Sustainable work participation, Preventive work intervention
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), The Dutch Brain Foundation
- Study start
- 8 Oct 2024 (actual)
- Primary completion
- 4 Mar 2027 (estimated)
- Study completion
- 4 Mar 2027 (estimated)
- First posted
- 27 Aug 2024 (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.
Work participation is essential for quality of life, providing purpose, social interaction, financial security, and shaping social status. Work participation is increasingly compromised in people with slowly progressive chronic disorders (hereafter referred to as progressive disorders). This negatively impacts their quality of life. Early work-related support, focused on sustainable work-retention, has the potential to enhance work participation in people with progressive disorders. Therefore, this study investigates the (cost)effectiveness of the Preventive Participatory Workplace Intervention (PPWI), a personalized work intervention to enhance sustainable work participation. The investigators perform an 18-month randomized controlled trial (RCT). In addition, the investigators perform a process evaluation and an economic evaluation alongside the RCT. 124 Dutch working persons with three types of movement disorders (Parkinson's Disease (PD), cerebellar ataxia (CA) and hereditary spastic paraparesis (HSP)) and with slowly progressive neuromuscular and mitochondrial disorders will be included.
Detailed description
Work participation is essential for quality of life, providing purpose, social interaction, financial security, and shaping social status and personal identity. Work participation is increasingly compromised in people with progressive disorders. This negatively impacts their quality of life. People with slowly progressive chronic disorders (hereafter referred to as progressive disorders) lack (structural) work-related support. Early work-related support, focused on sustainable work-retention, has the potential to enhance work participation in people with progressive disorders. Therefore, the EQuAL-study (Enhancement of Quality of work And Life) investigates the (cost)effectiveness of the Preventive Participatory Workplace Intervention (PPWI), a personalized intervention to enhance sustainable work participation in people with progressive disorders. The aim of the study is to investigate study effects of the PPWI on need for recovery after work (primary endpoint), perceived self-efficacy at work, work-related well-being, quality of life and absenteeism (secondary outcomes). In addition, the PPWI's cost-effectiveness and cost-utility and its the process of implementation and mechanisms of impact will be explored (second and third aim, respectively). To address these aims, the investigators perform an 18 month randomized controlled trial (RCT). A cost and process evaluation will be performed alongside the RCT. 124 Dutch working persons with types of movement disorders will be included: Parkinson's Disease (PD), cerebellar ataxia (CA), and hereditary spastic paraparesis (HSP) and with slowly progressive neuromuscular and mitochondrial disorders. Participants will be recruited from approximately twelve regions across the Netherlands. Participants will be randomised to either the PPWI or an usual care control group in a 1:1 ratio. The PPWI is a process intervention in which a trained process facilitator guides an employee and their manager in identifying work-related obstacles or changes and finding solutions to overcome or manage these obstacles. Its primary goal is to achieve consensus between employee and manager with respect to the most obstructive obstacles for functioning at work and feasible solutions. There are no restrictions on usual care. The study will evaluate between-group differences from baseline to 18-month follow-up in need for recovery after work (primary endpoint) and self-efficacy at work and indicators of quality of life, work-related well-being, and productivity (i.e. absenteeism and presenteeism). For the second aim, the investigators will measure the costs associated with healthcare use, productivity loss, work-related adjustments, and the intervention. For the third aim, the investigators will evaluate the process in terms of implementation of the PPWI, its mechanisms of impact and the implementation context. The investigators envision the PPWI to support sustainable work retention while preserving work-life balance and quality of life for individuals with progressive disorders. Additionally, the trial will provide insights into which intervention components are effective and why. This will help potential future PPWI users in making informed decisions about whether the costs are justified by the anticipated value and benefits.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are assigned to either the PPWI (intervention) or the usual care (control) group, in a 1:1 ratio.
| Arm | Type | Receives |
|---|---|---|
| Preventive Participatory workplace intervention (PPWI) | Experimental | Behavioral: Preventive Participatory workplace interventionParticipants in the PPWI group will receive the PPWI and continue to receive usual care. |
| Usual care control group | No intervention | –The usual care control group comprises usual care. There are no restrictions on usual care. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- having a diagnosis Parkinson Disease, cerebellar ataxia, hereditairy spastic paraparesis, or a slowly progressive neuromuscular or mitochondrial disorder, confirmed by the treating physician (e.g. neurologist, rehabilitation physician)
- aged 18-65 years;
- being employed for at least 8 hours per week (at baseline). This also includes individuals who have reduced their working hours until reaching this threshold of 8 hours per week. Working time may be distributed across multiple working days;
- having the intention to continue to work during the study period of 18 months, to prevent inclusion of participants who plan to retire within the 18-month RCT period;
- being open to talk to the employer or manager about any changes or limitations in work performance (disclosing the diagnosis is not required, by law).
Key exclusion criteria (5 listed)
- individuals who are at the beginning of a sick leave procedure (under the Gatekeeper Improvement Act; Wvp);
- being fully self-employed. Partial self-employment in addition to paid employment is allowed, on the condition that the paid employment accounts for more than half of the total weekly working hours;
- having a second employer for over eight hours per week;
- proficiency in the Dutch language is not sufficient;
- severe comorbidity or health-related event that will hamper compliance to the protocol, e.g. in case of a severe cognitive impairment, a relatively abrupt transition to a very progressive manifestation of the disease, a planned surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preventive Participatory workplace interventionThe Participatory Workplace Intervention (PPWI) is a process intervention in which a trained process facilitator guides an employee and their manager in identifying work-related obstacles or changes and finding solutions to overcome or manage these obstacles. Its primary goal is to achieve consensus between employee and manager with respect to the most obstructive obstacles for functioning at work and feasible solutions. Following consensus, the stakeholders formulate and agree upon a plan of action and execute the plan. In a subsequent meeting, the implementation of the plan of action will be evaluated. Six months after the evaluation, a follow-up will take place to determine whether new obstacles have emerged and whether a new cycle of process steps should be initiated. | Behavioural | Preventive Participatory workplace intervention (PPWI) |
Primary outcome
Need for recovery after work
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Need for recovery after work is measured using the subscale need for recovery after work of the Dutch language version of the Questionnaire on the Experience and Evaluation of Work questionnaire (VBBA 2.0).
10 secondary outcomes
Perceived self-efficacy at work
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Work home interference (WHI)
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Limitations in work
Time frame: Measured four timepoints: at baseline, and after 6, 12 and 18 months
Work-related stress
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Job satisfaction
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Perceived balance in daily activities (i.e. life balance)
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Health-related Quality of Life (QoL)
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Overall life satisfaction
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Absenteeism
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Presenteeism
Time frame: Measured four times: at baseline, and after 6, 12 and 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: Yes. Relevant and anonymised research data will be shared/published in the Radboud Data Repository (RDR) to guarantee long-term accessibility to the research data of the project of this research.
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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.
Elbrich Postma, PhD principal investigator
Radboud University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preventive Participatory workplace intervention in people with Parkinson Disease and Hereditary Spastic Paraparesis, run by Radboud University Medical Center at 1 site in Netherlands.
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 5 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: under way, not looking for participants, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. 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?
This study is still under way. Results are not available in the source record yet.
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?
Need for recovery after work (time frame: Measured four times: at baseline, and after 6, 12 and 18 months). 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 14 Aug 2026.