Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06573866
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-11
Brief Title:
Enhancement of Quality of Work And Life
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Enhancement of Quality of Work And Life A Personalised Process-based Work Intervention for People With Neurodegenerative Movement Disorders
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EQuAL
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 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 NdMDs will be included Parkinsons Disease PD Atypical Parkinsonism AP ataxia 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 NdMD This negatively impacts their quality of life People with NdMD lack structural work-related support Early work-related support focused on sustainable work-retention has the potential to enhance work participation in people with NdMD Therefore the EQuAL-study Enhancement of Quality of work And Life investigates the effectiveness of the Participatory Workplace Intervention PWI a personalized intervention to enhance quality of work quality of life and work-life balance The aim of the study is to investigate study effects of the PWI on need for recovery after work primary endpoint perceived self-efficacy at work work-related well-being quality of life and absenteeism secondary outcomes Additionally the costs of not receiving the PWI will be exploratively evaluated so as the process of implementation and the interventions mechanisms of impact To address these aims the investigators perform an 18 month single-blind remote randomized controlled trial RCT In addition a process evaluation alongside the RCT will be performed 124 Dutch working persons with four types of NdMDs will be included Parkinsons Disease PD Atypical Parkinsonism AP ataxia and hereditary spastic paraparesis HSP Participants will be recruited from approximately twelve regions across the Netherlands Participants will be randomised to either the PWI or an usual care control group in a 11 ratio The PWI is a process intervention in which a trained process facilitator guides an employee and their manager in identifying work-related obstacles 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 absenteeism secondary aim For the third aim the investigators will measure the costs associated with healthcare use productivity loss work-related adjustments and the intervention For the fourth aim the investigators will evaluate the process in terms of implementation of the PWI the mechanisms of impact and the implementation context The investigators envision the PWI 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 its potential national implementation and application to other neurodegenerative diseases
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None