Parkinson DiseaseOPTIM-PARKIINCT05583994
Optimising Community Resources and Support to Enhance Living With Parkinson's Disease
A study testing Optim Park Intervention in people with Parkinson Disease, run by University of Southampton at 4 sites in 2 countries.
Trial summary
This is a multi-centre, single-blinded, randomized, controlled trial for PwPD (people with Parkinson's Disease) to compare (i) OPTIM-PARK II (a novel personalized treatment based on the latest published research evidence and results from our extensive development work undertaken in OPTIM-PARK I) and routine care with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Optim Park Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 264 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 13 Jul 2022to 31 Mar 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- PwPD are eligible to be included in the trial if they meet the following criteria:
- Have a confirmed Consultant's diagnosis of Parkinson's disease.
- Live at home.
- Able to give informed consent.
- Able to understand and follow commands.
- Willing to take part in the Optim Park II intervention.
Show all 12Show fewer
- Carers of PwPD are eligible to be included in the trial if they meet the following criteria:
- The PwPD they are caring for has given informed consent.
- Live at home.
- Able to give informed consent.
- Able to understand and follow commands.
- Willing to take part in the Optim Park II intervention.
Who cannot join
- Participants who are currently hospitalised or acutely unwell will not be eligible to being included in the trial.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Spain2 sites
Hospital Universitario la Princesa, Madrid, Spain
Madrid, 28006
Autonomous University of Madrid/Nursing Department
Madrid, 28029
United Kingdom2 sites
Salisbury NHS Foundation Trust
Salisbury, Hampshire, SP28BJ
University of Southampton
Southampton, Hampshire, SO17 1BJ
About this study
Official title: OPTIM-PARK II -A New Intervention for Optimisation of Community Resources and Systems of Support to Enhance the Process of Living With Parkinson's Disease: a Feasibility Trial
This is a multi-centre, single-blinded, randomized, controlled trial for PwPD (people with Parkinson's Disease) to compare (i) OPTIM-PARK II (a novel personalized treatment based on the latest published research evidence and results from our extensive development work undertaken in OPTIM-PARK I) and routine care with (ii) routine care alone. The research team will provide a personalized list of available resources to the routine care arm at the end of the trial. The trial aims to recruit 60 PwPD and their carers (n=60) in the UK. This trial took place in 4 countries (Denmark, Norway, Spain and UK) but only Spain and UK included control groups, data collection in these two countries started in October 2022, after the iterative phase of the trial.
At the screening visit participants will be asked whether they would also be willing to take part in an additional qualitative study. A subgroup of participants will be selected from those that have indicated a willingness to take part in the qualitative study. Also, at the screening visit participants will be asked whether they have a carer. Having a carer is not a pre-requisite for PwPD being recruited into the trial. It is likely that some PwPD in the trial may not have a suitable carer. Where one is available, they will be invited to join the trial: if there is more than one, the main family carer, as identified by the PwPD, will be approached.
Read the detailed description
This is a multi-centre, single-blinded, randomised, controlled trial for PwPD to compare (i) OPTIM-PARK II (a novel personalised treatment based on the latest published research evidence and results from our extensive development work undertaken in OPTIM-PARK I) and routine care with (ii) routine care alone. The research team will provide a personalised list of available resources to the routine care arm at the end of the trial. The trial aims to recruit 60 PwPD and their carers (n=60) in the UK. This trial took place in 4 countries (Denmark, Norway, Spain and UK) but only Spain and UK included control groups, data collection in these two countries started in October 2022, after the iterative phase of the trial.
Participants allocated to the control group will received usual care and participants in the intervention group the Optim Park intervention.
This intervention will consist of the following:
First consultation with PwPD and carer "entrance" at point of entry to the study
The initial consultation with the PwPD and the carer will be a face-to-face consultation in the participants own home or at the clinic/primary care centre/community hub based on participants preference.
This consultation will include steps which are detailed below.
Step 1. Welcome and clarification of expectations PwPD and their carer will be welcomed to the Optim-Park II intervention. In this step, the coordinator and the PwPD and the carer will get to know each other and the clarification of expectations for this intervention will take place. The coordinator will outline that the consultation is intended to allow participants to gain information about available public and private services, community and volunteer-based resources that are available to them. In this step, the coordinator will record the resources that the PwPD and carer have already accessed or used in the past and will record this in the resource log.
Step 2. Personalised assessment and needs clarification A personalised assessment will be carried out with PwPD and carers in collaboration with the coordinator to explore and identify their needs.
For PwPD To enable this process, the PwPD and the coordinator will have access to the Living with long term conditions scale (completed during the baseline assessment) which they can use as a conversation starter to encourage PwPD to reflect on their experience of living with PD. The coordinator might also use the map of resources for clarification of needs.
For carers The carer and the coordinator will have access use the Carer Support Needs Assessment Tool (CSNAT) (completed during the baseline assessment) which they can use as a conversation starter to explore in which areas the carer require support to enable them to care for the PwPD and to preserve their own health and well-being within their caregiving role. The coordinator might also use the map of resources for clarification of needs.
Step 3. Choice of focus Based on the personalised assessment and needs clarification the coordinator, in collaboration with the PwPD and the carer, will identify the main 3 issues/areas they each want to address or need the most help and support. The coordinator will document each of their 3 issues using the Log of resources. This way the coordinators and PwPD and the carer can revisit this in the following consultations.
Step 4. Information selection Together the coordinator, PwPD and carer will decide about what resources would like to be informed about or referred to in order to tackle the main issues/areas identified in Step 2. The coordinator will in collaboration with the PwPD and carer identify which resources could best address accommodate their issues/areas of focus. Together the coordinator, the PwPD and the carer will select resources from the map of resources that are considered appropriate and acceptable for the PwPD and the carer. The coordinator will use the Log of resources to help the PwPD and the carer identify and record what were chosen to be most beneficial to their current situation and according to their expressed needs.
Step 5. Enable use of resources The coordinator will inform the PwPD and their carer about the resources and professional services available that they have selected in the previous step, and about how to access those resources/services. The coordinator will provide clear and concise information and not use technical language and outline potential individual benefits that the PwPD and carer could achieve and how this might support addressing the problems identified in step 2.
The Coordinator will use the Map of Resources to inform the PwPD and carer of the resource options available in their area. The information provided by the Coordinator may be complemented with the delivery of printed or digital material (eg: web pages; and a copy of the Map of Resources in a version designed for PwPD and carer).
The Coordinator will use the Log to record the information they have provided to PwPD and carer about community resources and professional services.
The main objective of this step is that PwPD and carers are informed so that they can use the resources as and when they want to access them. In addition, referrals, signposting and first contact can also be made in this step based on the personalized assessment of needs.
Step 6. Intervention Follow-ups The Coordinator in collaboration with PwPD and carers can decide and make the next appointment depending on when and how the next follow-up consultation will take place. It is recommended to specify the day, time and place of the next consultation before ending the initial consultation. The PwPD and their carer will be informed that they can contact the coordinator with any problems and queries via phone or email at any point without having to make another appointment.
Second consultation: Intervention "as needed" This second consultation will be initiated by the coordinator if they have not heard back from the PwPD by phone in the middle of the 3-month follow-up.
The coordinator will ask the PwPD and carer about any thoughts and progress made or problems encountered following their discussion in the previous consultation. In particular, the coordinator might ask about the three problems identified in the initial consultation and doubts or uncertainties that have arisen after their initial consultation.
If the PwPD and carer have not found the identified resources useful or helpful, the coordinator will offer to inform them of other or different resources. If the PwPD or carer are struggling to make the first contact or engaging with available resources, the coordinator will offer to support the participants. At the end of this phone call consultation, the coordinator in collaboration with PwPD and carers will decide on the date, place and time of the next and last consultation.
Third consultation: Intervention exit This third and final consultation will be face-to-face in the participants own home or at the clinic/primary care centre, by phone or digital, based on participant preference 3 months after entry to the intervention.
The coordinator will ask the PwPD and Carer about their progress made in dealing with the main 3 problems identified during the initial consultations. The coordinator will record which resources were accessed, continued or discontinued and record how useful participants found these resources in relation to addressing the main 3 problems identified.
At the end of the meeting, the coordinator will answer any final questions and ensure that participants have a copy of the map of local resources.
- Conditions
- Parkinson Disease
- Being tested
- Optim Park Intervention
- Keywords
- community, Parkinson's Disease, Carers
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optim Park InterventionOther
For participants receiving the Optim-Park II intervention, the aim is to enhance the process of living with Parkinson's Disease for the person with PD and the family-carer by building a multisectoral care pathway, with a special focus on how to optimize the use of resources and systems of support in the community in disadvantaged populations in UK.
| Study group | Role | What they receive |
|---|---|---|
| Usual care ( control) | No intervention | All participants in the trial will continue with their usual care as deemed appropriate by health care providers, this will usually comprise attendance at medical clinics, medication, and visits from PD nurse specialists. Participants may attend group activities or access resources as part of their usual care, though from experience such sessions are rarely intensive or prolonged. Participants will be asked to record their usual care and encouraged to avoid changing that practice unless specifically requested by a health care worker during the time they are participating in the trial. |
| Optim Park Intervention | Experimental | A central component of the Optim-Park II intervention is to offer a single point of contact with a coordinator (appointed for the purpose of delivering the Optim-Park II intervention) to assess participants needs, have a discussion with participants to identify 3 main problems/targets PwPD and carers would most like to address based on their needs and then link up and refer participants to available community resources.
The coordinators will deliver the Optim-Park intervention for PwPD and their carers in three consultations: a consultation after the baseline assessment and randomization has been undertaken at the point of "entrance" to the study; a consultation in the middle of this period; and a follow-up consultation at "exit" at 3 months. Each consultation can last between 30 min and up to 2 hours. Each consultation can be with the pair of PwPD and carer or if appropriate, separately. Receives: Other: Optim Park Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resources used in the community (assessing change)
Resources identified and used as recorded in the Resource log (by the coordinator) and in the resource log diary (by patients and carers)
Measured: Completed at baseline and 3 months post randomisation follow-up assessment
Secondary outcomes (6)
Parkinson Disease Quality of Life 39 questionnaire (assessing change)
Quality of Life Person with Parkinson Disease (0-100) (lower scores better Quality of Life)
Measured: Completed at baseline and 3 months post randomisation follow-up assessment
Parkinson Disease quality of life Carer Scale (assessing change)
Quality of Life Carer (0-100) (lower scores better Quality of Life)
Measured: Completed at baseline and 3 months post randomisation follow-up assessment
Caregiver Burden Scale (assessing change)
Caregiver Burden (0-84) (higher scores indicate more burden)
Measured: Completed at baseline and 3 months post randomisation follow-up assessment
Duke University of Carolina Social support Questionnaire (assessing change)
Social support (1-5 average score) (higher scores meaning better social support)
Measured: Completed at baseline and 3 months post randomisation follow-up assessment
Health and social care resource use sheet (assessing change)
Economic analysis
Measured: Completed at baseline and 3 months post randomisation follow-up assessment
Euro Quality of Life 5 Dimension (assessing change)
Economic analysis (1-15 individual questions (1 best posible score) and Visual Analogue Scale (0-100, 100 best health possible)
Measured: Completed at baseline and 3 months post randomisation follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2022
- Study start13 Jul 2022
- Primary completion31 Mar 2023
- Study completion31 Mar 2023
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Control and intervention groups (usual care vs new intervention)
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 264 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Southampton
- Sponsor type
- University, hospital or other
- Collaborators
- Solent NHS Trust, Salisbury NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583994
- Sponsor's protocol ID
- 308776
- Acronym
- OPTIM-PARKII
- Status last verified
- Apr 2023
- First submitted
- 1 Sep 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIM-PARK II -A New Intervention for Optimisation of Community Resources and Systems of Support to Enhance the Process of Living With Parkinson's Disease: a Feasibility Trial
- ClinicalTrials.gov ID
- NCT05583994
- Acronym / sponsor ID
- OPTIM-PARKII / 308776
- Conditions
- Parkinson Disease
- Keywords
- community, Parkinson's Disease, Carers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 264 participants (actual)
- Lead sponsor
- University of SouthamptonUniversity, hospital or other
- Collaborators
- Solent NHS Trust, Salisbury NHS Foundation Trust
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 18 Oct 2022 (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.
This is a multi-centre, single-blinded, randomized, controlled trial for PwPD (people with Parkinson's Disease) to compare (i) OPTIM-PARK II (a novel personalized treatment based on the latest published research evidence and results from our extensive development work undertaken in OPTIM-PARK I) and routine care with (ii) routine care alone. The research team will provide a personalized list of available resources to the routine care arm at the end of the trial. The trial aims to recruit 60 PwPD and their carers (n=60) in the UK. This trial took place in 4 countries (Denmark, Norway, Spain and UK) but only Spain and UK included control groups, data collection in these two countries started in October 2022, after the iterative phase of the trial.
At the screening visit participants will be asked whether they would also be willing to take part in an additional qualitative study. A subgroup of participants will be selected from those that have indicated a willingness to take part in the qualitative study. Also, at the screening visit participants will be asked whether they have a carer. Having a carer is not a pre-requisite for PwPD being recruited into the trial. It is likely that some PwPD in the trial may not have a suitable carer. Where one is available, they will be invited to join the trial: if there is more than one, the main family carer, as identified by the PwPD, will be approached.
Detailed description
This is a multi-centre, single-blinded, randomised, controlled trial for PwPD to compare (i) OPTIM-PARK II (a novel personalised treatment based on the latest published research evidence and results from our extensive development work undertaken in OPTIM-PARK I) and routine care with (ii) routine care alone. The research team will provide a personalised list of available resources to the routine care arm at the end of the trial. The trial aims to recruit 60 PwPD and their carers (n=60) in the UK. This trial took place in 4 countries (Denmark, Norway, Spain and UK) but only Spain and UK included control groups, data collection in these two countries started in October 2022, after the iterative phase of the trial.
Participants allocated to the control group will received usual care and participants in the intervention group the Optim Park intervention.
This intervention will consist of the following:
First consultation with PwPD and carer "entrance" at point of entry to the study
The initial consultation with the PwPD and the carer will be a face-to-face consultation in the participants own home or at the clinic/primary care centre/community hub based on participants preference.
This consultation will include steps which are detailed below.
Step 1. Welcome and clarification of expectations PwPD and their carer will be welcomed to the Optim-Park II intervention. In this step, the coordinator and the PwPD and the carer will get to know each other and the clarification of expectations for this intervention will take place. The coordinator will outline that the consultation is intended to allow participants to gain information about available public and private services, community and volunteer-based resources that are available to them. In this step, the coordinator will record the resources that the PwPD and carer have already accessed or used in the past and will record this in the resource log.
Step 2. Personalised assessment and needs clarification A personalised assessment will be carried out with PwPD and carers in collaboration with the coordinator to explore and identify their needs.
For PwPD To enable this process, the PwPD and the coordinator will have access to the Living with long term conditions scale (completed during the baseline assessment) which they can use as a conversation starter to encourage PwPD to reflect on their experience of living with PD. The coordinator might also use the map of resources for clarification of needs.
For carers The carer and the coordinator will have access use the Carer Support Needs Assessment Tool (CSNAT) (completed during the baseline assessment) which they can use as a conversation starter to explore in which areas the carer require support to enable them to care for the PwPD and to preserve their own health and well-being within their caregiving role. The coordinator might also use the map of resources for clarification of needs.
Step 3. Choice of focus Based on the personalised assessment and needs clarification the coordinator, in collaboration with the PwPD and the carer, will identify the main 3 issues/areas they each want to address or need the most help and support. The coordinator will document each of their 3 issues using the Log of resources. This way the coordinators and PwPD and the carer can revisit this in the following consultations.
Step 4. Information selection Together the coordinator, PwPD and carer will decide about what resources would like to be informed about or referred to in order to tackle the main issues/areas identified in Step 2. The coordinator will in collaboration with the PwPD and carer identify which resources could best address accommodate their issues/areas of focus. Together the coordinator, the PwPD and the carer will select resources from the map of resources that are considered appropriate and acceptable for the PwPD and the carer. The coordinator will use the Log of resources to help the PwPD and the carer identify and record what were chosen to be most beneficial to their current situation and according to their expressed needs.
Step 5. Enable use of resources The coordinator will inform the PwPD and their carer about the resources and professional services available that they have selected in the previous step, and about how to access those resources/services. The coordinator will provide clear and concise information and not use technical language and outline potential individual benefits that the PwPD and carer could achieve and how this might support addressing the problems identified in step 2.
The Coordinator will use the Map of Resources to inform the PwPD and carer of the resource options available in their area. The information provided by the Coordinator may be complemented with the delivery of printed or digital material (eg: web pages; and a copy of the Map of Resources in a version designed for PwPD and carer).
The Coordinator will use the Log to record the information they have provided to PwPD and carer about community resources and professional services.
The main objective of this step is that PwPD and carers are informed so that they can use the resources as and when they want to access them. In addition, referrals, signposting and first contact can also be made in this step based on the personalized assessment of needs.
Step 6. Intervention Follow-ups The Coordinator in collaboration with PwPD and carers can decide and make the next appointment depending on when and how the next follow-up consultation will take place. It is recommended to specify the day, time and place of the next consultation before ending the initial consultation. The PwPD and their carer will be informed that they can contact the coordinator with any problems and queries via phone or email at any point without having to make another appointment.
Second consultation: Intervention "as needed" This second consultation will be initiated by the coordinator if they have not heard back from the PwPD by phone in the middle of the 3-month follow-up.
The coordinator will ask the PwPD and carer about any thoughts and progress made or problems encountered following their discussion in the previous consultation. In particular, the coordinator might ask about the three problems identified in the initial consultation and doubts or uncertainties that have arisen after their initial consultation.
If the PwPD and carer have not found the identified resources useful or helpful, the coordinator will offer to inform them of other or different resources. If the PwPD or carer are struggling to make the first contact or engaging with available resources, the coordinator will offer to support the participants. At the end of this phone call consultation, the coordinator in collaboration with PwPD and carers will decide on the date, place and time of the next and last consultation.
Third consultation: Intervention exit This third and final consultation will be face-to-face in the participants own home or at the clinic/primary care centre, by phone or digital, based on participant preference 3 months after entry to the intervention.
The coordinator will ask the PwPD and Carer about their progress made in dealing with the main 3 problems identified during the initial consultations. The coordinator will record which resources were accessed, continued or discontinued and record how useful participants found these resources in relation to addressing the main 3 problems identified.
At the end of the meeting, the coordinator will answer any final questions and ensure that participants have a copy of the map of local resources.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Control and intervention groups (usual care vs new intervention)
| Arm | Type | Receives |
|---|---|---|
| Usual care ( control) | No intervention | –All participants in the trial will continue with their usual care as deemed appropriate by health care providers, this will usually comprise attendance at medical clinics, medication, and visits from PD nurse specialists. Participants may attend group activities or access resources as part of their usual care, though from experience such sessions are rarely intensive or prolonged. Participants will be asked to record their usual care and encouraged to avoid changing that practice unless specifically requested by a health care worker during the time they are participating in the trial. |
| Optim Park Intervention | Experimental | Other: Optim Park InterventionA central component of the Optim-Park II intervention is to offer a single point of contact with a coordinator (appointed for the purpose of delivering the Optim-Park II intervention) to assess participants needs, have a discussion with participants to identify 3 main problems/targets PwPD and carers would most like to address based on their needs and then link up and refer participants to available community resources. The coordinators will deliver the Optim-Park intervention for PwPD and their carers in three consultations: a consultation after the baseline assessment and randomization has been undertaken at the point of "entrance" to the study; a consultation in the middle of this period; and a follow-up consultation at "exit" at 3 months. Each consultation can last between 30 min and up to 2 hours. Each consultation can be with the pair of PwPD and carer or if appropriate, separately. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- PwPD are eligible to be included in the trial if they meet the following criteria:
- Carers of PwPD are eligible to be included in the trial if they meet the following criteria:
- The PwPD they are caring for has given informed consent.
- Live at home.
- Able to give informed consent.
Key exclusion criteria (1 listed)
- Participants who are currently hospitalised or acutely unwell will not be eligible to being included in the trial.
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 |
|---|---|---|
| Optim Park InterventionFor participants receiving the Optim-Park II intervention, the aim is to enhance the process of living with Parkinson's Disease for the person with PD and the family-carer by building a multisectoral care pathway, with a special focus on how to optimize the use of resources and systems of support in the community in disadvantaged populations in UK. | Other | Optim Park Intervention |
Primary outcome
Resources used in the community (assessing change)
Time frame: Completed at baseline and 3 months post randomisation follow-up assessment
Resources identified and used as recorded in the Resource log (by the coordinator) and in the resource log diary (by patients and carers)
6 secondary outcomes
Parkinson Disease Quality of Life 39 questionnaire (assessing change)
Time frame: Completed at baseline and 3 months post randomisation follow-up assessment
Parkinson Disease quality of life Carer Scale (assessing change)
Time frame: Completed at baseline and 3 months post randomisation follow-up assessment
Caregiver Burden Scale (assessing change)
Time frame: Completed at baseline and 3 months post randomisation follow-up assessment
Duke University of Carolina Social support Questionnaire (assessing change)
Time frame: Completed at baseline and 3 months post randomisation follow-up assessment
Health and social care resource use sheet (assessing change)
Time frame: Completed at baseline and 3 months post randomisation follow-up assessment
Euro Quality of Life 5 Dimension (assessing change)
Time frame: Completed at baseline and 3 months post randomisation follow-up assessment
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 1 May 2023.
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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.
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optim Park Intervention in people with Parkinson Disease, run by University of Southampton at 4 sites in 2 countries.
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 12 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 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Spain, 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?
Resources used in the community (assessing change) (time frame: Completed at baseline and 3 months post randomisation follow-up assessment). 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 1 May 2023.