Enhancement of Quality of Work And Life (NCT06573866) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Enhancement of Quality of Work And Life
Netherlands124 participantsStarted 2024-10-08
Plain-language 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 (Parkinson's Disease (PD), cerebellar ataxia (CA) and hereditary spastic paraparesis (HSP)) and with slowly progressive neuromuscular and mitochondrial disorders will be included.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on 'need for recovery after work' in people with conditions like Parkinson's disease, hereditary spastic paraparesis, or neuromuscular diseases — given my specific diagnosis, does my doctor think my situation fits closely enough with what this study is actually measuring to make it worth pursuing?
2Since the trial is listed as 'active not recruiting,' is there any way to find out if a waitlist exists, or whether a similar study on work quality and fatigue management might be open and accepting patients right now?
3This study is categorized as Phase NA, which often means it's not testing a drug or device but rather a behavioral or quality-of-life intervention — can my doctor explain what that likely means for what I'd actually be doing as a participant, and whether the demands would be realistic given my current condition?
4Given that the trial measures 'need for recovery after work,' what standard or established supports — like occupational therapy or workplace accommodations — are already available to me right now that might address the same concerns this study is exploring?
5Even if I can't enroll at this point, would my doctor be willing to review any published results or protocols from this trial to inform how we manage fatigue and work-life balance as part of my ongoing care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Need for recovery after work
Timeframe: Measured four times: at baseline, and after 6, 12 and 18 months