Enhancement of Quality of Work And Life
NCT Number: NCT06573866
Acronym: EQuAL
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Parkinson Disease|Ataxia|Hereditary Spastic Paraparesis|Parkinsonism
Interventions: BEHAVIORAL: Participatory workplace intervention
Sponsor: Radboud University Medical Center
Collaborators: Amsterdam University Medical Center|Netherlands Brain Foundation
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 124
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-09
Completion Date: 2027-01-04

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 (NdMD). 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 NdMD. Therefore, this study investigates the effectiveness of the Participatory Workplace Intervention (PWI), a personalized work intervention to enhance quality of work, quality of life and work-life balance. The investigators perform an 18-month single-blind remote randomized controlled trial (RCT). In addition, the investigators perform a process evaluation alongside the RCT. 124 Dutch working persons with four types of NdMD's will be included: Parkinson's Disease (PD), Atypical Parkinsonism (AP), ataxia and hereditary spastic paraparesis (HSP).

Primary Outcome Measures: 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: 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|Work-life balance, Work-life balance 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|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|Perceived balance in daily activities, Satisfaction with balance in daily activities as a parameter for quality of life, 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 with an extension with a cognitive domain (EuroQol 5D (EQ-5D+C))., 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|Absenteeism, Participants will be asked to retrieve their own absenteeism data of the past six months from their employer. The following data will be collected: the number of days absent, and the number of sick and recovery notifications and reason for absenteeism. If data on the reason for absence is not available or provided, the nature of the absenteeism will be estimated with this mix of indicators, as illness from a flu typically results in relatively short-term absence.

Absenteeism will be expressed by the number of absenteeism days and number of sick notifications., Measured four times: at baseline, and after 6, 12 and 18 months
Other Outcome Measures: Healthcare costs, Healthcare costs encompass direct costs associated with delivering healthcare, including costs for both primary and secondary care. Data on the healthcare services used will be collected with a questionnaire. The calculation of healthcare costs will be done after all data on healthcare services used is collected. The calculation involves applying tariffs determined for the services of healthcare professionals, in accordance with the cost calculation guidelines established for healthcare in the Netherlands., Measured four times: at baseline, and after 6, 12 and 18 months|Productivity (loss) costs, Productivity costs encompass the financial impact on paid labour resulting from the illness, sick leave, or disability of an otherwise productive individual and will be measured and valued with the iMTA Productivity Cost Questionnaire (iPCQ)., Measured four times: at baseline, and after 6, 12 and 18 months|Costs for work-related adjustments, Participants will be asked to retrieve data on costs for work-related adjustments from their employer., Measured four times: at baseline, and after 6, 12 and 18 months|Intervention costs, The costs for the intervention consist of the direct and indirect working hours of the intervention provider and travel time. The costs will be calculated based on the work hour registration by the intervention providers and the guidelines for healthcare professionals (for occupational therapy) in the Netherlands., Measured at 18 months after baseline|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)