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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Southampton
- Enrollment
- 264
- Locations
- 8
- Primary Endpoint
- Resources used in the community (assessing change)
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
Participants cannot be blinded to the intervention they are receiving. Outcome assessors and the main investigators are blinded to group allocation and will not have access to the intervention treatment lists. Only the statistician performing the randomization, the team member supporting the coordinator and the coordinator who is delivering the intervention are aware of group allocation.
However, previous experience has shown that participants may occasionally and inadvertently inform assessors of the treatment they are receiving. The research team aim to reduce this effect by explicit reminders to participants before assessment visits. The research team shall ask all assessors to record their estimate of which group they think the participant belongs, and their confidence in that prediction. This will enable to test whether inadvertent loss of blinding leads to bias, and to adjust for any bias detected.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
- •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.
Exclusion Criteria
- •Participants who are currently hospitalised or acutely unwell will not be eligible to being included in the trial.
Outcomes
Primary Outcomes
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)
Secondary Outcomes
- Parkinson Disease quality of life Carer Scale (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Parkinson Disease Quality of Life 39 questionnaire (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Caregiver Burden Scale (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Health and social care resource use sheet (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Euro Quality of Life 5 Dimension (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)
- Duke University of Carolina Social support Questionnaire (assessing change)(Completed at baseline and 3 months post randomisation follow-up assessment)