Enhancement of Quality of Work And Life

NCT06573866 | Recruiting

• 1 other identifier: 115335
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Perceived self-efficacy at work

  Measured four times: at baseline, and after 6, 12 and 18 months

• Work home interference (WHI)

  Measured four times: at baseline, and after 6, 12 and 18 months

• Limitations in work

  Measured four timepoints: at baseline, and after 6, 12 and 18 months

• Work-related stress

  Measured four times: at baseline, and after 6, 12 and 18 months

• Job satisfaction

  Measured four times: at baseline, and after 6, 12 and 18 months

Other Outcomes (15)

• Healthcare and occupational service utilization

  Measured four three times: at 6, 12 and 18 months

• Productivity (loss) costs (due to absenteeism)

  Measured four times: at baseline, and after 6, 12 and 18 months

• Productivity (loss) costs (due to presenteeism and loss unpaid work)

  Measured four times: at baseline, and after 6, 12 and 18 months

Study Arms (2)

Preventive Participatory workplace intervention (PPWI)

EXPERIMENTAL

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

Behavioral: Preventive Participatory workplace intervention

Usual care control group

NO INTERVENTION

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

Interventions

Preventive Participatory workplace intervention 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.

Preventive Participatory workplace intervention (PPWI)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead
• Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA): collaborator
• The Dutch Brain Foundation: collaborator

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525 GA, Netherlands

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Spastic Paraplegia, Hereditary; Cerebellar Ataxia; Mitochondrial Diseases; Neuromuscular Diseases; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Hereditary Sensory and Motor Neuropathy; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Polyneuropathies; Peripheral Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Cerebellar Diseases; Ataxia; Dyskinesias; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Elbrich Postma, PhD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pauline van Barschot

CONTACT

+31615483989; pauline.vanbarschot@radboudumc.nl

Elbrich Postma, PhD

CONTACT

elbrich.postma@radboudumc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: July 11, 2024
• First Posted: August 27, 2024
• Study Start: October 8, 2024
• Primary Completion (Estimated): January 4, 2027
• Study Completion (Estimated): January 4, 2027
• Last Updated: May 29, 2025

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: After completion of the measurements and analysis, relevant and anonymised research data will be placed on the RDR.
• 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.

Locations

NL (1)