Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05583994 |
| Other study ID # |
308776 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
July 13, 2022 |
| Est. completion date |
March 31, 2023 |
Study information
| Verified date |
April 2023 |
| Source |
University of Southampton |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 (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.
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.
