Enhancement of Quality of Work And Life
- Conditions
- Parkinson DiseaseHereditary Spastic ParaparesisParkinsonismCerebellar Ataxia
- Interventions
- Behavioral: Participatory workplace intervention
- Registration Number
- NCT06573866
- Lead Sponsor
- Radboud University Medical Center
- 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 neurodegenerative movement disorders (hereafter referred to as movement 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 movement 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 four types of movement disorders will be included: Parkinson's Disease (PD), Atypical Parkinsonism (AP), cerebellar ataxia (CA) and hereditary spastic paraparesis (HSP).
- 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 neurodegenerative movement disorders (hereafter referred to as movement disorders). This negatively impacts their quality of life. People with movement 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 movement 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 movement 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 four types of movement disorders will be included: Parkinson's Disease (PD), Atypical Parkinsonism (AP), cerebellar ataxia (CA) and hereditary spastic paraparesis (HSP). 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 NdMD. 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 124
- having a confirmed diagnosis PD, AP, AC or HSP diagnosis by the neurologist;
- being 18-65 years of age;
- 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).
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Participatory workplace intervention (PWI) Participatory workplace intervention Participants in the PWI group will receive the PWI and continue to receive usual care.
- Primary Outcome Measures
Name Time Method Need for recovery after work 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).
- Secondary Outcome Measures
Name Time Method Absenteeism Measured four times: at baseline, and after 6, 12 and 18 months 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.
Presenteeism Measured four times: at baseline, and after 6, 12 and 18 months 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).
Perceived self-efficacy at work Measured four times: at baseline, and after 6, 12 and 18 months 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.
Work home interference (WHI) Measured four times: at baseline, and after 6, 12 and 18 months Work home interference (WHI) is measured with the subscale negative work-home interaction of the Survey Work-home Interaction - NijmeGen (SWING).
Limitations in work Measured four timepoints: at baseline, and after 6, 12 and 18 months Limitations in work is measured with the Dutch language version of the Work Limitations Questionnaire (WLQ-mdlv).
Work-related stress Measured four times: at baseline, and after 6, 12 and 18 months 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.
Job satisfaction Measured four times: at baseline, and after 6, 12 and 18 months 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.
Perceived balance in daily activities (i.e. life balance) Measured four times: at baseline, and after 6, 12 and 18 months 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).
Health-related Quality of Life (QoL) Measured four times: at baseline, and after 6, 12 and 18 months Health-related QoL is measured with the EuroQuality of Life Five Dimension (EuroQol 5D (EQ-5D-5L)).
Overall life satisfaction Measured four times: at baseline, and after 6, 12 and 18 months 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.
Trial Locations
- Locations (1)
Radboudumc
🇳🇱NIjmegen, Gelderland, Netherlands