Enhancement of Quality of Work And Life

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-08

Study Completion Date

2027-01-04

Brief Summary

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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.

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Detailed Description

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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

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Parkinson Disease Hereditary Spastic Paraparesis Cerebellar Ataxia Mitochondrial Diseases Neuromuscular Diseases (NMD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to either the PPWI (intervention) or the usual care (control) group, in a 1:1 ratio.

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

In the beginning of the trial, the investigator was masked. However, during the trial we decided that unmasking the investigator was more feasible, as the fully automatic procedures in Castor EDC eliminate the risk of influencing allocation or data collection for effectiveness outcomes.

Study Groups

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Preventive Participatory workplace intervention (PPWI)

Participants in the PPWI group will receive the PPWI and continue to receive usual care.

Group Type EXPERIMENTAL

Preventive Participatory workplace intervention

Intervention Type BEHAVIORAL

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.

Usual care control group

The usual care control group comprises usual care. There are no restrictions on usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No