Clinical trial NCT06573866: Enhancement of Quality of Work And Life
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: The Dutch Brain Foundation
First posted: 2024-08-27
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants are assigned to either the PPWI (intervention) or the usual care (control) group, in a 1:1 ratio.
Primary purpose: SUPPORTIVE_CARE

Brief 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). 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Need for recovery after work
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
Secondary outcomes:
measure: Perceived self-efficacy at work
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Work home interference (WHI)
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Limitations in work
timeFrame: Measured four timepoints: at baseline, and after 6, 12 and 18 months
measure: Work-related stress
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Job satisfaction
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Perceived balance in daily activities (i.e. life balance)
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Health-related Quality of Life (QoL)
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Overall life satisfaction
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Absenteeism
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Presenteeism
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
Other outcomes:
measure: Healthcare and occupational service utilization
timeFrame: Measured four three times: at 6, 12 and 18 months
measure: Productivity (loss) costs (due to absenteeism)
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Productivity (loss) costs (due to presenteeism and loss unpaid work)
timeFrame: Measured four times: at baseline, and after 6, 12 and 18 months
measure: Costs for work-related adjustments
timeFrame: Measured one timepoint: at 18 months
measure: Intervention costs
timeFrame: 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.
measure: Recruitment (process evaluation outcome)
timeFrame: Pre-intervention (2 weeks before start recruitment),during recruitment period (monthly registration), 2 weeks after end recruitment period.
measure: Reach (process evaluation outcome)
timeFrame: 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.
measure: Dose delivered (process evaluation outcome)
timeFrame: 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.
measure: Dose received (process evaluation outcome)
timeFrame: Post-intervention (at 18 months after baseline)
measure: Fidelity (process evaluation outcome)
timeFrame: 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.
measure: Quality of delivery (process evaluation outcome)
timeFrame: Post-intervention (at 18 months after baseline)
measure: Satisfaction with the intervention (process evaluation outcome)
timeFrame: Post-intervention (at 18 months after baseline)
measure: Perceived impact (process evaluation outcome)
timeFrame: Post-intervention (in period of 18-20 months after baseline)
measure: Perceived benefit for participants (process evaluation outcome)
timeFrame: 1 year after inclusion of last participants
measure: Facilitators and barriers (process evaluation outcome)
timeFrame: Post-intervention (in period of 18-20 months after baseline)
Locations:
city: NIjmegen
country: Netherlands
facility: Radboudumc
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Elbrich Postma, PhD
role: PRINCIPAL_INVESTIGATOR
References: