Enhancement of Quality of Work And Life (EQuAL)

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 will be included: Parkinson's Disease (PD), cerebellar ataxia (CA) and hereditary spastic paraparesis (HSP) and with slowly progressive neuromuscular and mitochondrial disorders.

Study Overview

• Status: Recruiting
• Conditions: Mitochondrial Diseases; Parkinson Disease; Cerebellar Ataxia; Hereditary Spastic Paraparesis; Neuromuscular Diseases (NMD)
• Intervention / Treatment: Behavioral: Preventive Participatory workplace intervention

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 Type: Interventional
• Enrollment (Estimated): 124
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Pauline van Barschot; Phone Number: +31615483989; Email: pauline.vanbarschot@radboudumc.nl
• Study Contact Backup: Name: Elbrich Postma, PhD; Email: elbrich.postma@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • NIjmegen, Gelderland, Netherlands, 6525 GA
      • Recruiting
      • Radboudumc
      • Contact: Pauline van Barschot; Phone Number: +31615483989; Email: pauline.vanbarschot@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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).

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual care control group; The usual care control group comprises usual care. There are no restrictions on usual care.
Experimental: Preventive Participatory workplace intervention (PPWI); Participants in the PPWI group will receive the PPWI and continue to receive usual care.	Behavioral: Preventive Participatory workplace intervention; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 four times: at baseline, and after 6, 12 and 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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 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 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 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 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 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 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 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 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 four times: at baseline, and after 6, 12 and 18 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment (process evaluation outcome)	Recruitment strategies that are used to reach and recruit participants. The recruitment strategies are registered by the investigator.	Pre-intervention (2 weeks before start recruitment),during recruitment period (monthly registration), 2 weeks after end recruitment period.
Reach (process evaluation outcome)	Proportion of the target audience that participates in the intervention. Reach is determined, based on: the number of individuals invited to participate in the trial, number of individuals potentially interested and the number of participants who participated (in the intervention group). Data on these variables are registered by the intervention providers.	Weekly registration, from the date of randomization of the first participant until the date of randomization of the last participant, assessed up to 18 months.
Dose delivered (process evaluation outcome)	Dose delivered is determined by the amount of meetings planned and intervention steps provided according to the protocol by the intervention providers. Dose delivered is determined, based on: the number of meetings that have taken place and the number of process steps that have been performed. Data on these variables will be retrieved from the intervention providers, by questionnaires.	After every intervention-session with a participant, from the date on which the first participant starts with the intervention until 18 months after the date of inclusion of the last participant.
Dose received (process evaluation outcome)	Dose received is the extent to which participants actively engage with the intervention. Dose received is determined, based on: the extent to which all stakeholders involved have implemented the solutions as proposed during the participatory workplace intervention. Data on this outcome is retrieved by both participants and intervention providers, by questionnaires.	Post-intervention (at 18 months after baseline)
Fidelity (process evaluation outcome)	Fidelity is the extent to which the intervention steps are delivered according to the protocol. Fidelity is determined, based on: whether the predefined fidelity criteria have been reached. Data on fidelity is retrieved from the intervention providers, by a questionnaire.	After every intervention-session with a participant, from the date on which the first participant starts with the intervention until 18 months after the date of inclusion of the last participant.
Quality of delivery (process evaluation outcome)	Perceived quality of the delivery of the intervention by the intervention providers. Data on quality will be retrieved from participants, by a questionnaire.	Post-intervention (at 18 months after baseline)
Satisfaction with the intervention (process evaluation outcome)	Satisfaction with the intervention in general, intervention steps, materials of the intervention, the intervention provider and the solutions that came out of the intervention. Data on satisfaction with the intervention will be retrieved from participants, by a questionnaire.	Post-intervention (at 18 months after baseline)
Perceived impact (process evaluation outcome)	Perceived impact/effect is determined, based on: whether and how participants experienced that the intervention improved working and/or living conditions and functioning and which components of the intervention contributed to that (or not) Data on perceived impact of the intervention will be retrieved from (a subset of) participants, through semi-structured in-depth interviews.	Post-intervention (in period of 18-20 months after baseline)
Perceived benefit for participants (process evaluation outcome)	Perceived benefit for participants is determined, based on: whether and how intervention providers perceived that the intervention improved working and/or living conditions and functioning of participants and which components of the intervention contributed to that (or not). Data on perceived benefit will be retrieved from the intervention providers, through focus-group interviews.	1 year after inclusion of last participants
Facilitators and barriers (process evaluation outcome)	Factors that either facilitate or hamper functioning and implementation of the intervention. Data will be retrieved from both intervention providers through focus-group interviews and from (a subset of) participants, through semi-structured in-depth interviews.	Post-intervention (in period of 18-20 months after baseline)
Healthcare and occupational service utilization	Primary and secondary healthcare and occupational service utilization (e.g. appointment with a rehabilitation physician, a physiotherapist or an occupational physician) will be measured through questionnaires. Participants will be asked to keep track of their healthcare and occupational service utilization over the past six months prior to each measurement. For this purpose, we provide participants with a scheme. Healthcare costs will be obtained by multiplying the utilization quantities with the costs per quantity, based on the cost calculation guidelines established for healthcare in the Netherlands in 2024. Occupational service utilization costs are calculated using tariffs for occupational service professionals.	Measured four three times: at 6, 12 and 18 months
Productivity (loss) costs (due to absenteeism)	Absenteeism data that are collected for the purpose of the effect evaluation, will be included as a third component. For the absenteeism costs, different calculation approaches will be used for the societal and employer's perspective (for the purpose of the economic evaluation). The societal perspective applies the iPCQ calculation guidelines, using the friction cost method. This method is based on the assumption that employees on long-term sick leave are eventually replaced. As a result, productivity losses primarily occur during the period required for an employer to replace an absent employee, known as the friction period. For the employer's perspective, absenteeism costs will be estimated using the Human Capital Approach (HCA).	Measured four times: at baseline, and after 6, 12 and 18 months
Productivity (loss) costs (due to presenteeism and loss unpaid work)	Productivity loss due to presenteeism and loss unpaid work will be measured and valued using two iMTA Productivity Cost Questionnaire (iPCQ) modules [50], measuring productivity losses of paid work due to presenteeism and losses related to unpaid work. Costs will be calculated according to the iPCQ calculation guidelines and a standard production costs per hour.	Measured four times: at baseline, and after 6, 12 and 18 months
Costs for work-related adjustments	Prior to T3, participants will be asked to retrieve data on work-related adjustments of the entire study period from their employer. The employer will be responsible for approving requested adjustments and must have documented the approval and any acquisition of the adjustments. Adjustments include material adjustments, such as an adapted desk chair, as well as adjustments like employing an assistant who takes over certain tasks. At T3, participants will fill in these requested data through a questionnaire. If costs for the adjustments are not provided together with the adjustment-data by the employer, average costs for acquisition of the adjustments will be used.	Measured one timepoint: at 18 months
Intervention costs	Data on time spent on the PPWI trajectory by process facilitators will be collected continuously through checklists. Process facilitators will report the actual (direct) time and indirect participant-related time spent per meeting, and, if applicable, the travel time. The intervention costs will be calculated by multiplying the hours registered by the process facilitators with the tariffs for occupational therapy in the Netherlands.	After every intervention-session with a participant, from the date on which the first participant starts with the intervention until 18 months after the date of inclusion of the last participant.

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); The Dutch Brain Foundation
• Investigators: Principal Investigator: Elbrich Postma, PhD, Radboud University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2024
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2027

Study Registration Dates

• First Submitted: July 11, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2025
• Last Update Submitted That Met QC Criteria: May 22, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: Quality of life; Randomized controlled trial; Work; Neurodegenerative disorders; Work-life balance; Need for recovery; Sustainable work participation; Preventive work intervention
• Additional Relevant MeSH Terms: Synucleinopathies; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Neurodegenerative Diseases; Movement Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Dyskinesias; Cerebellar Diseases; Paresis; Parkinson Disease; Ataxia; Cerebellar Ataxia; Paraparesis; Paraparesis, Spastic; Mitochondrial Diseases; Neuromuscular Diseases
• Other Study ID Numbers: 115335

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: After completion of the measurements and analysis, relevant and anonymised research data will be placed on the RDR.
• IPD Sharing Access Criteria: The pseudonymized research data will be accessible in the RDR under restricted access. This means that researchers who are interested in re-use of the data are asked to contact the central contact person for permission. Approval is given after a signed agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No