Parkinson DiseaseNCT03905954
The Impact of a Diagnosis of Parkinson's on Work
An observational study of Parkinson Disease, run by Oxford Brookes University at 1 site in United Kingdom.
Trial summary
Parkinson's disease leads to loss of employment on average within less than 10 years of disease onset and has been found to be associated with an increased absence from work. This combined with hospitalisation; use of secondary health services; drug usage; and caregivers needing to give up work contributed to the… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Parkinson Disease
- How many people
- 696 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 11 Apr 2019to 4 Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A (European) community based convenience sample. The survey will be available to the European Parkinson's Disease Association (EPDA) network using the Members' forum and website and will be sign posted through ongoing Member Outreach communication channels.
Who may be able to join
- Diagnosis of Parkinson
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Oxford Brookes University
Oxford, Oxfordshire, OX3 0SB
About this study
Parkinson's disease leads to loss of employment on average within less than 10 years of disease onset and has been found to be associated with an increased absence from work. This combined with hospitalisation; use of secondary health services; drug usage; and caregivers needing to give up work contributed to the costs associated with the conditions. It has been estimated that early support for working age newly diagnosed would cost the government about 1.5 million Euro in the UK but might lead to a potential cost saving of over half a billion over 5 years.
The study will explore the impact of a Parkinson diagnosis on employment. The study will be survey based and will include demographic questions: age, age at diagnosis of PD, educational level, and Nationality; questions pertaining to employment type, history, and reasons for leaving if this happened; and also general health.
- Conditions
- Parkinson Disease
- Being tested
- Usual care
- Keywords
- employment, work, diagnosis, early support
- Medical subject headings
- Parkinson Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Usual careOther
For this cross sectional survey, participants will be receiving usual care according to there health care systems
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Diagnosis | Usual care Receives: Other: Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Main occupation in the last 7 days
Questions asks: 'Which of these descriptions applies to your main occupation in the last seven days? and has the following options.
'In paid work (OR AWAY TEMPORARILY) (employee, self-employed, working for your family business) Unemployed and actively looking for a job Unemployed, wanting a job but not actively looking for a job Permanently sick or disabled In community or military service Doing housework, looking after children or other persons Retired In paid work (OR AWAY TEMPORARILY) (employee, self-employed, working for your family business) Unemployed and actively looking for a job Unemployed, wanting a job but not actively looking for a job Permanently sick or disabled In community or military service Doing housework, looking after children or other persons Retired Student
Measured: baseline only (cross sectional)
Secondary outcomes (9)
Type of Work
Questions asks: 'Which category would best describe your current main occupation or skill set?' Managers or directors Professionals Technicians and Associate Professionals Clerical Support Workers Services and Sales Workers Skilled Agricultural, Forestry, and Fishery Workers Craft and Related Trades Workers Plant and Machine Operators and Assemblers Elementary Occupations eg salespersons, domestic, helpers, porters Armed Forces Occupations
Measured: baseline only (cross sectional)
Symptom Severity-Distress
0-10 visual analogue scale (0 worst - 10 best)
Measured: baseline only (cross sectional)
Symptom Severity-Pain
0-10 visual analogue scale (0 worst - 10 best)
Measured: baseline only (cross sectional)
Symptom Severity-Fatigue
0-10 visual analogue scale (0 worst - 10 best)
Measured: baseline only (cross sectional)
Symptom Severity-Depression
0-10 visual analogue scale (0 worst - 10 best)
Measured: baseline only (cross sectional)
Symptom Severity-Anxiety
0-10 visual analogue scale (0 worst - 10 best)
Measured: baseline only (cross sectional)
Symptom Severity - Sleep
0-10 visual analogue scale (0 worst - 10 best)
Measured: baseline only (cross sectional)
Single Item Physical activity
Days per week of physical activity lasting 30 minutes or longer on a 0-7 integer scale
Measured: baseline only (cross sectional)
Single Item Diet
Portions of fruit and vegetables consume per day on a 0-5+ integer scale
Measured: baseline only (cross sectional)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2019
- Study start11 Apr 2019
- Primary completion4 Nov 2019
- Study completion4 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 696 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oxford Brookes University
- Sponsor type
- University, hospital or other
- Collaborators
- European Parkinson's Therapy Centre
- Responsible party
- Principal investigator, Dr Johnny Collett, Oxford Brookes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03905954
- Sponsor's protocol ID
- MOReS-EPTC-EPDA
- Status last verified
- Mar 2020
- First submitted
- 4 Apr 2019
- Last updated
- 3 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Diagnosis of Parkinson's on Work
- ClinicalTrials.gov ID
- NCT03905954
- Acronym / sponsor ID
- MOReS-EPTC-EPDA
- Conditions
- Parkinson Disease
- Keywords
- employment, work, diagnosis, early support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 696 participants (actual)
- Lead sponsor
- Oxford Brookes UniversityUniversity, hospital or other
- Collaborators
- European Parkinson's Therapy Centre
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 4 Nov 2019 (actual)
- Study completion
- 4 Nov 2019 (actual)
- First posted
- 8 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Parkinson's disease leads to loss of employment on average within less than 10 years of disease onset and has been found to be associated with an increased absence from work. This combined with hospitalisation; use of secondary health services; drug usage; and caregivers needing to give up work contributed to the costs associated with the conditions. It has been estimated that early support for working age newly diagnosed would cost the government about 1.5 million Euro in the UK but might lead to a potential cost saving of over half a billion over 5 years.
The study will explore the impact of a Parkinson diagnosis on employment. The study will be survey based and will include demographic questions: age, age at diagnosis of PD, educational level, and Nationality; questions pertaining to employment type, history, and reasons for leaving if this happened; and also general health.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Diagnosis | – | Other: Usual careUsual care |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A (European) community based convenience sample. The survey will be available to the European Parkinson's Disease Association (EPDA) network using the Members' forum and website and will be sign posted through ongoing Member Outreach communication channels.
Key inclusion criteria (1 listed)
- Diagnosis of Parkinson
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual careFor this cross sectional survey, participants will be receiving usual care according to there health care systems | Other | Parkinson's Diagnosis |
Primary outcome
Main occupation in the last 7 days
Time frame: baseline only (cross sectional)
Questions asks: 'Which of these descriptions applies to your main occupation in the last seven days? and has the following options. 'In paid work (OR AWAY TEMPORARILY) (employee, self-employed, working for your family business) Unemployed and actively looking for a job Unemployed, wanting a job but not actively looking for a job Permanently sick or disabled In community or military service Doing housework, looking after children or other persons Retired In paid work (OR AWAY TEMPORARILY) (employee, self-employed, working for your family business) Unemployed and actively looking for a job Unemployed, wanting a job but not actively looking for a job Permanently sick or disabled In community or military service Doing housework, looking after children or other persons Retired Student
9 secondary outcomes
Type of Work
Time frame: baseline only (cross sectional)
Symptom Severity-Distress
Time frame: baseline only (cross sectional)
Symptom Severity-Pain
Time frame: baseline only (cross sectional)
Symptom Severity-Fatigue
Time frame: baseline only (cross sectional)
Symptom Severity-Depression
Time frame: baseline only (cross sectional)
Symptom Severity-Anxiety
Time frame: baseline only (cross sectional)
Symptom Severity - Sleep
Time frame: baseline only (cross sectional)
Single Item Physical activity
Time frame: baseline only (cross sectional)
Single Item Diet
Time frame: baseline only (cross sectional)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Oxford Brookes University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main occupation in the last 7 days (time frame: baseline only (cross sectional)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2020.