Optimising Community Resources and Support to Enhance Living With Parkinson's Disease

NCT05583994 | Completed DMC

• 1 other identifier: 308776
• Study Type: interventional
• Target: 264
• Locations: 2 countries
• Sites: 4

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.

Conditions

Parkinson Disease

Keywords

community; Parkinson's Disease; Carers

Outcome Measures

Primary Outcomes (1)

• 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)

  Completed at baseline and 3 months post randomisation follow-up assessment

Secondary Outcomes (6)

• Parkinson Disease Quality of Life 39 questionnaire (assessing change)

  Completed at baseline and 3 months post randomisation follow-up assessment

• Parkinson Disease quality of life Carer Scale (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

• Duke University of Carolina Social support Questionnaire (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

Study Arms (2)

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.

Other: Optim Park Intervention

Interventions

Optim Park Intervention OTHER

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.

Optim Park Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants who are currently hospitalised or acutely unwell will not be eligible to being included in the trial.

Sponsors & Collaborators

• University of Southampton: lead
• Solent NHS Trust: collaborator
• Salisbury NHS Foundation Trust: collaborator

Study Sites (4)

Hospital Universitario la Princesa, Madrid, Spain

Madrid, 28006, Spain

Location

Autonomous University of Madrid/Nursing Department

Madrid, 28029, Spain

Location

Salisbury NHS Foundation Trust

Salisbury, Hampshire, SP28BJ, United Kingdom

Location

University of Southampton

Southampton, Hampshire, SO17 1BJ, United Kingdom

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Control and intervention groups (usual care vs new intervention)

Study Record Dates

• First Submitted: September 1, 2022
• First Posted: October 18, 2022
• Study Start: July 13, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Locations

ES (2); GB (2)